TBD Meeting (3187-19)

PHILADELPHIA – Elagolix has emerged as an effective second-tier treatment option for patients with dysmenorrhea attributed to endometriosis, Charles E. Miller, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

Although clinicians need prior authorization and evidence of treatment failure before prescribing Elagolix, the drug is a viable option as a second-tier treatment for patients with endometriosis-associated dysmenorrhea, said Dr. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. “We have a drug that is very effective, that has a very low adverse event profile, and is tolerated by the vast majority of our patients.”

First-line options

NSAIDs are first-line treatment for endometriosis-related dysmenorrhea, with acetaminophen used in cases where NSAIDs are contraindicated or cause side effects such as gastrointestinal issues. Hormonal contraceptives also can be used as first-line treatment, divided into estrogen/progestin and progestin-only options that can be combined. Evidence from the literature has shown oral pills decrease pain, compared with placebo, but the decrease is not dose dependent, said Dr. Miller.

“We also know that if you use it continuously or prolonged, we find that there is going to be greater success with dysmenorrhea, and that ultimately you would use a higher-dose pill because of the greater risk of breakthrough when using a lesser dose in a continuous fashion,” he said. “Obviously if you’re not having menses, you’re not going to have dysmenorrhea.”

Other estrogen/progestin hormonal contraception such as the vaginal ring or transdermal patch also have been shown to decrease dysmenorrhea from endometriosis, with one study showing a reduction from 17% to 6% in moderate to severe dysmenorrhea in patients using the vaginal ring, compared with patients receiving oral contraceptives. In a separate randomized, controlled trial, “dysmenorrhea was more common in patch users, so it doesn’t appear that the patch is quite as effective in terms of reducing dysmenorrhea,” said Dr. Miller (JAMA. 2001 May 9. doi: 10.1001/jama.285.18.2347).

Compared with combination hormone therapy, there has been less research conducted on progestin-only hormone contraceptives on reducing dysmenorrhea from endometriosis. For example, there is little evidence for depot medroxyprogesterone acetate in reducing dysmenorrhea, but rather with it causing amenorrhea; one study showed a 50% amenorrhea rate at 1 year. “The disadvantage, however, in our infertile population is ultimately getting the menses back,” said Dr. Miller.

IUDs using levonorgestrel appear comparable with gonadotropin-releasing hormone (GnRH) agonists in reducing endometriosis-related pain; in one study, most women treated with either of these had visual analogue scores of less than 3 at 6 months of treatment. Between 68% and 75% of women with dysmenorrhea who receive an implantable contraceptive device with etonogestrel report decreased pain, and one meta-analysis reported 75% of women had “complete resolution of dysmenorrhea.” Concerning progestin-only pills, they can be used for endometriosis-related dysmenorrhea, but they are “problematic in that there’s a lot of breakthrough bleeding, and often times that is associated with pain,” said Dr. Miller.

Second-tier options

Injectable GnRH agonists are effective options as second-tier treatments for endometriosis-related dysmenorrhea, but patients are at risk of developing postmenopausal symptoms such as hot flashes, insomnia, spotting, and decreased libido. “One advantage to that is, over the years and particularly something that I’ve done with my endometriosis-related dysmenorrhea, is to utilize add-back with these patients,” said Dr. Miller, who noted that patients on 2.5 mg of norethindrone acetate and 0.5 mg of ethinyl estradiol“do very well” with that combination of add-back therapy.

Elagolix is the most recent second-tier treatment option for these patients, and was studied in the Elaris EM-I and Elaris EM-II trials in a once-daily dose of 150 mg and a twice-daily dose of 200 mg. In Elaris EM-1, 76% of patients in the 200-mg elagolix group had a clinical response, compared with 46% in the 150-mg group and 20% in the placebo group (N Engl J Med. 2017 Jul 6. doi: 10.1056/NEJMoa1700089). However, patients should not be on elagolix at 200 mg for more than 6 months, while patients receiving elagolix at 150 mg can stay on the treatment for up to 2 years.

Patients taking elagolix also showed postmenopausal symptoms, with 24% in the 150-mg group and 46% in the 200-mg group experiencing hot flashes, compared with 9% of patients in the placebo group. While 6% of patients in the 150-mg group and 10% in the 200-mg group discontinued because of adverse events, 1% and 3% of patients in the 150-mg and 200-mg group discontinued because of hot flashes or night sweats, respectively. “Symptoms are well tolerated, far different than in comparison with leuprolide acetate and GnRH agonists,” said Dr. Miller.

There also is a benefit to how patients recover from bone mineral density (BMD) changes after remaining on elagolix, Dr. Miller noted. In patients who received elagolix for 12 months at doses of 150 mg and 200 mg, there was an increase in lumbar spine BMD recovered 6 months after discontinuation, with patients in the 150-mg group experiencing a recovery close to baseline BMD levels. Among patients who discontinued treatment, there also was a quick resumption in menses for both groups: 87% of patients in the 150 mg group and 88% of patients in the 200-mg group who discontinued treatment after 6 months had resumed menses by 2 months after discontinuation, while 95% of patients in the 150-mg and 91% in the 200-mg group who discontinued after 12 months resumed menses by 2 months after discontinuation.

Dr. Miller reported relationships with AbbVie, Allergan, Blue Seas Med Spa, Espiner Medical, Gynesonics, Halt Medical, Hologic, Karl Storz, Medtronic, and Richard Wolf in the form of consultancies, grants, speakers’ bureau appointments, stock options, royalties, and ownership interests.

PHILADELPHIA – Elagolix has emerged as an effective second-tier treatment option for patients with dysmenorrhea attributed to endometriosis, Charles E. Miller, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

Although clinicians need prior authorization and evidence of treatment failure before prescribing Elagolix, the drug is a viable option as a second-tier treatment for patients with endometriosis-associated dysmenorrhea, said Dr. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. “We have a drug that is very effective, that has a very low adverse event profile, and is tolerated by the vast majority of our patients.”

First-line options

NSAIDs are first-line treatment for endometriosis-related dysmenorrhea, with acetaminophen used in cases where NSAIDs are contraindicated or cause side effects such as gastrointestinal issues. Hormonal contraceptives also can be used as first-line treatment, divided into estrogen/progestin and progestin-only options that can be combined. Evidence from the literature has shown oral pills decrease pain, compared with placebo, but the decrease is not dose dependent, said Dr. Miller.

“We also know that if you use it continuously or prolonged, we find that there is going to be greater success with dysmenorrhea, and that ultimately you would use a higher-dose pill because of the greater risk of breakthrough when using a lesser dose in a continuous fashion,” he said. “Obviously if you’re not having menses, you’re not going to have dysmenorrhea.”

Other estrogen/progestin hormonal contraception such as the vaginal ring or transdermal patch also have been shown to decrease dysmenorrhea from endometriosis, with one study showing a reduction from 17% to 6% in moderate to severe dysmenorrhea in patients using the vaginal ring, compared with patients receiving oral contraceptives. In a separate randomized, controlled trial, “dysmenorrhea was more common in patch users, so it doesn’t appear that the patch is quite as effective in terms of reducing dysmenorrhea,” said Dr. Miller (JAMA. 2001 May 9. doi: 10.1001/jama.285.18.2347).

Compared with combination hormone therapy, there has been less research conducted on progestin-only hormone contraceptives on reducing dysmenorrhea from endometriosis. For example, there is little evidence for depot medroxyprogesterone acetate in reducing dysmenorrhea, but rather with it causing amenorrhea; one study showed a 50% amenorrhea rate at 1 year. “The disadvantage, however, in our infertile population is ultimately getting the menses back,” said Dr. Miller.

IUDs using levonorgestrel appear comparable with gonadotropin-releasing hormone (GnRH) agonists in reducing endometriosis-related pain; in one study, most women treated with either of these had visual analogue scores of less than 3 at 6 months of treatment. Between 68% and 75% of women with dysmenorrhea who receive an implantable contraceptive device with etonogestrel report decreased pain, and one meta-analysis reported 75% of women had “complete resolution of dysmenorrhea.” Concerning progestin-only pills, they can be used for endometriosis-related dysmenorrhea, but they are “problematic in that there’s a lot of breakthrough bleeding, and often times that is associated with pain,” said Dr. Miller.

Second-tier options

Injectable GnRH agonists are effective options as second-tier treatments for endometriosis-related dysmenorrhea, but patients are at risk of developing postmenopausal symptoms such as hot flashes, insomnia, spotting, and decreased libido. “One advantage to that is, over the years and particularly something that I’ve done with my endometriosis-related dysmenorrhea, is to utilize add-back with these patients,” said Dr. Miller, who noted that patients on 2.5 mg of norethindrone acetate and 0.5 mg of ethinyl estradiol“do very well” with that combination of add-back therapy.

Elagolix is the most recent second-tier treatment option for these patients, and was studied in the Elaris EM-I and Elaris EM-II trials in a once-daily dose of 150 mg and a twice-daily dose of 200 mg. In Elaris EM-1, 76% of patients in the 200-mg elagolix group had a clinical response, compared with 46% in the 150-mg group and 20% in the placebo group (N Engl J Med. 2017 Jul 6. doi: 10.1056/NEJMoa1700089). However, patients should not be on elagolix at 200 mg for more than 6 months, while patients receiving elagolix at 150 mg can stay on the treatment for up to 2 years.

Patients taking elagolix also showed postmenopausal symptoms, with 24% in the 150-mg group and 46% in the 200-mg group experiencing hot flashes, compared with 9% of patients in the placebo group. While 6% of patients in the 150-mg group and 10% in the 200-mg group discontinued because of adverse events, 1% and 3% of patients in the 150-mg and 200-mg group discontinued because of hot flashes or night sweats, respectively. “Symptoms are well tolerated, far different than in comparison with leuprolide acetate and GnRH agonists,” said Dr. Miller.

There also is a benefit to how patients recover from bone mineral density (BMD) changes after remaining on elagolix, Dr. Miller noted. In patients who received elagolix for 12 months at doses of 150 mg and 200 mg, there was an increase in lumbar spine BMD recovered 6 months after discontinuation, with patients in the 150-mg group experiencing a recovery close to baseline BMD levels. Among patients who discontinued treatment, there also was a quick resumption in menses for both groups: 87% of patients in the 150 mg group and 88% of patients in the 200-mg group who discontinued treatment after 6 months had resumed menses by 2 months after discontinuation, while 95% of patients in the 150-mg and 91% in the 200-mg group who discontinued after 12 months resumed menses by 2 months after discontinuation.

Dr. Miller reported relationships with AbbVie, Allergan, Blue Seas Med Spa, Espiner Medical, Gynesonics, Halt Medical, Hologic, Karl Storz, Medtronic, and Richard Wolf in the form of consultancies, grants, speakers’ bureau appointments, stock options, royalties, and ownership interests.

PHILADELPHIA – Elagolix has emerged as an effective second-tier treatment option for patients with dysmenorrhea attributed to endometriosis, Charles E. Miller, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

Although clinicians need prior authorization and evidence of treatment failure before prescribing Elagolix, the drug is a viable option as a second-tier treatment for patients with endometriosis-associated dysmenorrhea, said Dr. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. “We have a drug that is very effective, that has a very low adverse event profile, and is tolerated by the vast majority of our patients.”

First-line options

NSAIDs are first-line treatment for endometriosis-related dysmenorrhea, with acetaminophen used in cases where NSAIDs are contraindicated or cause side effects such as gastrointestinal issues. Hormonal contraceptives also can be used as first-line treatment, divided into estrogen/progestin and progestin-only options that can be combined. Evidence from the literature has shown oral pills decrease pain, compared with placebo, but the decrease is not dose dependent, said Dr. Miller.

“We also know that if you use it continuously or prolonged, we find that there is going to be greater success with dysmenorrhea, and that ultimately you would use a higher-dose pill because of the greater risk of breakthrough when using a lesser dose in a continuous fashion,” he said. “Obviously if you’re not having menses, you’re not going to have dysmenorrhea.”

Other estrogen/progestin hormonal contraception such as the vaginal ring or transdermal patch also have been shown to decrease dysmenorrhea from endometriosis, with one study showing a reduction from 17% to 6% in moderate to severe dysmenorrhea in patients using the vaginal ring, compared with patients receiving oral contraceptives. In a separate randomized, controlled trial, “dysmenorrhea was more common in patch users, so it doesn’t appear that the patch is quite as effective in terms of reducing dysmenorrhea,” said Dr. Miller (JAMA. 2001 May 9. doi: 10.1001/jama.285.18.2347).

Compared with combination hormone therapy, there has been less research conducted on progestin-only hormone contraceptives on reducing dysmenorrhea from endometriosis. For example, there is little evidence for depot medroxyprogesterone acetate in reducing dysmenorrhea, but rather with it causing amenorrhea; one study showed a 50% amenorrhea rate at 1 year. “The disadvantage, however, in our infertile population is ultimately getting the menses back,” said Dr. Miller.

IUDs using levonorgestrel appear comparable with gonadotropin-releasing hormone (GnRH) agonists in reducing endometriosis-related pain; in one study, most women treated with either of these had visual analogue scores of less than 3 at 6 months of treatment. Between 68% and 75% of women with dysmenorrhea who receive an implantable contraceptive device with etonogestrel report decreased pain, and one meta-analysis reported 75% of women had “complete resolution of dysmenorrhea.” Concerning progestin-only pills, they can be used for endometriosis-related dysmenorrhea, but they are “problematic in that there’s a lot of breakthrough bleeding, and often times that is associated with pain,” said Dr. Miller.

Second-tier options

Injectable GnRH agonists are effective options as second-tier treatments for endometriosis-related dysmenorrhea, but patients are at risk of developing postmenopausal symptoms such as hot flashes, insomnia, spotting, and decreased libido. “One advantage to that is, over the years and particularly something that I’ve done with my endometriosis-related dysmenorrhea, is to utilize add-back with these patients,” said Dr. Miller, who noted that patients on 2.5 mg of norethindrone acetate and 0.5 mg of ethinyl estradiol“do very well” with that combination of add-back therapy.

Elagolix is the most recent second-tier treatment option for these patients, and was studied in the Elaris EM-I and Elaris EM-II trials in a once-daily dose of 150 mg and a twice-daily dose of 200 mg. In Elaris EM-1, 76% of patients in the 200-mg elagolix group had a clinical response, compared with 46% in the 150-mg group and 20% in the placebo group (N Engl J Med. 2017 Jul 6. doi: 10.1056/NEJMoa1700089). However, patients should not be on elagolix at 200 mg for more than 6 months, while patients receiving elagolix at 150 mg can stay on the treatment for up to 2 years.

Patients taking elagolix also showed postmenopausal symptoms, with 24% in the 150-mg group and 46% in the 200-mg group experiencing hot flashes, compared with 9% of patients in the placebo group. While 6% of patients in the 150-mg group and 10% in the 200-mg group discontinued because of adverse events, 1% and 3% of patients in the 150-mg and 200-mg group discontinued because of hot flashes or night sweats, respectively. “Symptoms are well tolerated, far different than in comparison with leuprolide acetate and GnRH agonists,” said Dr. Miller.

There also is a benefit to how patients recover from bone mineral density (BMD) changes after remaining on elagolix, Dr. Miller noted. In patients who received elagolix for 12 months at doses of 150 mg and 200 mg, there was an increase in lumbar spine BMD recovered 6 months after discontinuation, with patients in the 150-mg group experiencing a recovery close to baseline BMD levels. Among patients who discontinued treatment, there also was a quick resumption in menses for both groups: 87% of patients in the 150 mg group and 88% of patients in the 200-mg group who discontinued treatment after 6 months had resumed menses by 2 months after discontinuation, while 95% of patients in the 150-mg and 91% in the 200-mg group who discontinued after 12 months resumed menses by 2 months after discontinuation.

Dr. Miller reported relationships with AbbVie, Allergan, Blue Seas Med Spa, Espiner Medical, Gynesonics, Halt Medical, Hologic, Karl Storz, Medtronic, and Richard Wolf in the form of consultancies, grants, speakers’ bureau appointments, stock options, royalties, and ownership interests.

PHILADELPHIA – Postmenopausal women are at risk of numerous medical conditions after the onset of menopause, but many ob.gyns feel uncomfortable treating those patients, according to a keynote speaker at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The population of women entering menopause continues to rise, and they are at risk for developing chronic diseases about a decade after the onset of menopause, said Rogerio A. Lobo, MD, professor of obstetrics and gynecology at Columbia University, New York.

“For me, from a primary care perspective, there’s a major opportunity for all of us providers at the onset of menopause to identify risks and initiate preventive strategies,” he said.

These newly menopausal women are at risk for diseases across multiple specialty areas, which include obesity, metabolic syndrome, diabetes, cardiovascular disease, osteoporosis, chronic arthritis, dementia, cognitive decline, depression, and cancer. “My focus along these lines is really longevity, reduction in mortality as well as quality of life,” said Dr. Lobo.

Understanding of the benefits of estrogen therapy for postmenopausal women began with work in two studies in the 1990s. One paper by Meir J. Stampfer, MD, and associates on 15 studies examining the effects of hormone therapy on coronary heart disease (CHD) found that the relative risk of estrogen therapy on the disease was 0.50 (95% confidence interval, 0.43-0.56) after adjusting for only prospective and angiographic studies (Prev Med. 1991;20[1]:47-63).

A second paper by Deborah Grady, MD, MPH, and associates found that hormone therapy with estrogen plus progestin decreased the risk of CHD and hip fracture in women but increased the risk of endometrial and breast cancer, and carried a recommendation for using estrogen plus progestin for women who have received a hysterectomy or who are at high risk for CHD (Ann Intern Med. 1992 Dec 15;117[12]:1016-37).

In the early 2000s, data from the Women’s Health Initiative (WHI) began to show a different story: Therapy with estrogen plus progestin was shown to carry risks of early harm in postmenopausal women, and one study by JoAnn E. Manson, MD, DrPH, and associates had a hazard ratio of 1.24 (nominal 95% confidence interval, 1.00-1.54) for CHD in postmenopausal women aged 50-79 years receiving the combined therapy (N Engl J Med. 2003;349:523-34).

The confidence intervals were later adjusted so the association was not significant, but the results led to conclusions that hormone therapy was harmful to women and increased risk of breast cancer, declining cognition, and dementia, as well as cardiovascular diseases such as coronary disease, stroke and thrombosis.

“That was the dogma for many people to this day, but it was clearly a rush to judgment,” said Dr. Lobo. “More harm than good was done for the field.”

The contradictory findings from the WHI and other studies may be explained by the timing of hormone therapy, Dr. Lobo explained. In the ELITE trial, 643 postmenopausal women, stratified into early-postmenopausal (less than 6 years) and late-postmenopausal (equal to or greater than 10 years) groups, received 1 mg of daily oral 17-beta-estradiol with 45 mg of progesterone vaginal gel or placebo. Researchers found that it was beneficial for preventing the progression of subclinical atherosclerosis when therapy was initiated in early but not in late menopause (N Eng J Med. 2016; 374:1221-31).

Estrogen also has benefits for the brain, and might help improve rates of cognitive decline and Alzheimer’s disease in postmenopausal women, Dr. Lobo said. Of the 1,768 women in the Cache County Study who described their use of hormone therapy after menopause, 176 women developed Alzheimer’s; however, use of hormone therapy within 5 years of menopause was associated with a 30% reduced risk of Alzheimer’s (95% confidence interval, 0.49-0.99) and had better benefits for long-term use up to 10 years. But this effect was not present in women who started hormone therapy 5 years or more after onset of menopause (Neurology. 2012 Oct 30. doi: 10.1212/WNL.0b013e318271f823).

Clinicians also should look at the risk of hormone therapy in terms of absolute real risk rather than relative risk. “In WHI, even though many of these events were not statistically significant, even if they assumed they were, the absolute numbers were 7-8 events per 10,000 women per year,” he said. “Those, according to WHI, are rare events if they’re even true.”

“For breast cancer, which is a big concern a lot of women have, endogenous risk factors are much higher than what hormones do,” he added.

Yet clinicians continue to act on data from the WHI, Dr. Lobo noted. In fact, many ob.gyns. report that they are uncomfortable treating women with symptoms associated with menopause.

“Post WHI, we have lost at least a generation of providers who do not deal with menopause,” he added. “Three out of four women who seek help for symptoms don’t receive it. The practice of menopause has largely disappeared from for many, many practices.”

The American Society for Reproductive Medicine used to have a “menopause day,” but the society no longer offers a track for menopause, Dr. Lobo said. One solution aimed at addressing the absence of training might be a menopause curriculum for ob.gyn. residents to help them initiate prevention strategies for postmenopausal women and have the confidence to manage this patient population. Dr. Lobo cited one study from Johns Hopkins where ob.gyn. residents underwent a 2-year menopause medicine curriculum and scored significantly higher on posttest scores after completing the program (78.7% vs. 57.3%; P less than .05). After the curriculum, 85.7% also reported they were more comfortable treating patients with menopause (Menopause. 2016 Mar. 23[3]:275-9).

Work also needs to be done on the front of understanding which hormone therapies are most effective for postmenopausal women. While there is currently no one hormone therapy to specifically recommend, in the future, pharmacogenetics and genetic or molecular risk analyses will play a role in knowing which products to prescribe. “It can be done, to be able to have a clear path for longevity and improved quality of life,” Dr. Lobo said.

Dr. Lobo reported serving as a consultant to Amgen, Mithra, Sojournix, and TherapeuticsMD. In addition, his institution is receiving support from Bayer and the National Institutes of Health for a clinical trial.

PHILADELPHIA – Postmenopausal women are at risk of numerous medical conditions after the onset of menopause, but many ob.gyns feel uncomfortable treating those patients, according to a keynote speaker at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The population of women entering menopause continues to rise, and they are at risk for developing chronic diseases about a decade after the onset of menopause, said Rogerio A. Lobo, MD, professor of obstetrics and gynecology at Columbia University, New York.

“For me, from a primary care perspective, there’s a major opportunity for all of us providers at the onset of menopause to identify risks and initiate preventive strategies,” he said.

These newly menopausal women are at risk for diseases across multiple specialty areas, which include obesity, metabolic syndrome, diabetes, cardiovascular disease, osteoporosis, chronic arthritis, dementia, cognitive decline, depression, and cancer. “My focus along these lines is really longevity, reduction in mortality as well as quality of life,” said Dr. Lobo.

Understanding of the benefits of estrogen therapy for postmenopausal women began with work in two studies in the 1990s. One paper by Meir J. Stampfer, MD, and associates on 15 studies examining the effects of hormone therapy on coronary heart disease (CHD) found that the relative risk of estrogen therapy on the disease was 0.50 (95% confidence interval, 0.43-0.56) after adjusting for only prospective and angiographic studies (Prev Med. 1991;20[1]:47-63).

A second paper by Deborah Grady, MD, MPH, and associates found that hormone therapy with estrogen plus progestin decreased the risk of CHD and hip fracture in women but increased the risk of endometrial and breast cancer, and carried a recommendation for using estrogen plus progestin for women who have received a hysterectomy or who are at high risk for CHD (Ann Intern Med. 1992 Dec 15;117[12]:1016-37).

In the early 2000s, data from the Women’s Health Initiative (WHI) began to show a different story: Therapy with estrogen plus progestin was shown to carry risks of early harm in postmenopausal women, and one study by JoAnn E. Manson, MD, DrPH, and associates had a hazard ratio of 1.24 (nominal 95% confidence interval, 1.00-1.54) for CHD in postmenopausal women aged 50-79 years receiving the combined therapy (N Engl J Med. 2003;349:523-34).

The confidence intervals were later adjusted so the association was not significant, but the results led to conclusions that hormone therapy was harmful to women and increased risk of breast cancer, declining cognition, and dementia, as well as cardiovascular diseases such as coronary disease, stroke and thrombosis.

“That was the dogma for many people to this day, but it was clearly a rush to judgment,” said Dr. Lobo. “More harm than good was done for the field.”

The contradictory findings from the WHI and other studies may be explained by the timing of hormone therapy, Dr. Lobo explained. In the ELITE trial, 643 postmenopausal women, stratified into early-postmenopausal (less than 6 years) and late-postmenopausal (equal to or greater than 10 years) groups, received 1 mg of daily oral 17-beta-estradiol with 45 mg of progesterone vaginal gel or placebo. Researchers found that it was beneficial for preventing the progression of subclinical atherosclerosis when therapy was initiated in early but not in late menopause (N Eng J Med. 2016; 374:1221-31).

Estrogen also has benefits for the brain, and might help improve rates of cognitive decline and Alzheimer’s disease in postmenopausal women, Dr. Lobo said. Of the 1,768 women in the Cache County Study who described their use of hormone therapy after menopause, 176 women developed Alzheimer’s; however, use of hormone therapy within 5 years of menopause was associated with a 30% reduced risk of Alzheimer’s (95% confidence interval, 0.49-0.99) and had better benefits for long-term use up to 10 years. But this effect was not present in women who started hormone therapy 5 years or more after onset of menopause (Neurology. 2012 Oct 30. doi: 10.1212/WNL.0b013e318271f823).

Clinicians also should look at the risk of hormone therapy in terms of absolute real risk rather than relative risk. “In WHI, even though many of these events were not statistically significant, even if they assumed they were, the absolute numbers were 7-8 events per 10,000 women per year,” he said. “Those, according to WHI, are rare events if they’re even true.”

“For breast cancer, which is a big concern a lot of women have, endogenous risk factors are much higher than what hormones do,” he added.

Yet clinicians continue to act on data from the WHI, Dr. Lobo noted. In fact, many ob.gyns. report that they are uncomfortable treating women with symptoms associated with menopause.

“Post WHI, we have lost at least a generation of providers who do not deal with menopause,” he added. “Three out of four women who seek help for symptoms don’t receive it. The practice of menopause has largely disappeared from for many, many practices.”

The American Society for Reproductive Medicine used to have a “menopause day,” but the society no longer offers a track for menopause, Dr. Lobo said. One solution aimed at addressing the absence of training might be a menopause curriculum for ob.gyn. residents to help them initiate prevention strategies for postmenopausal women and have the confidence to manage this patient population. Dr. Lobo cited one study from Johns Hopkins where ob.gyn. residents underwent a 2-year menopause medicine curriculum and scored significantly higher on posttest scores after completing the program (78.7% vs. 57.3%; P less than .05). After the curriculum, 85.7% also reported they were more comfortable treating patients with menopause (Menopause. 2016 Mar. 23[3]:275-9).

Work also needs to be done on the front of understanding which hormone therapies are most effective for postmenopausal women. While there is currently no one hormone therapy to specifically recommend, in the future, pharmacogenetics and genetic or molecular risk analyses will play a role in knowing which products to prescribe. “It can be done, to be able to have a clear path for longevity and improved quality of life,” Dr. Lobo said.

Dr. Lobo reported serving as a consultant to Amgen, Mithra, Sojournix, and TherapeuticsMD. In addition, his institution is receiving support from Bayer and the National Institutes of Health for a clinical trial.

PHILADELPHIA – Postmenopausal women are at risk of numerous medical conditions after the onset of menopause, but many ob.gyns feel uncomfortable treating those patients, according to a keynote speaker at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The population of women entering menopause continues to rise, and they are at risk for developing chronic diseases about a decade after the onset of menopause, said Rogerio A. Lobo, MD, professor of obstetrics and gynecology at Columbia University, New York.

“For me, from a primary care perspective, there’s a major opportunity for all of us providers at the onset of menopause to identify risks and initiate preventive strategies,” he said.

These newly menopausal women are at risk for diseases across multiple specialty areas, which include obesity, metabolic syndrome, diabetes, cardiovascular disease, osteoporosis, chronic arthritis, dementia, cognitive decline, depression, and cancer. “My focus along these lines is really longevity, reduction in mortality as well as quality of life,” said Dr. Lobo.

Understanding of the benefits of estrogen therapy for postmenopausal women began with work in two studies in the 1990s. One paper by Meir J. Stampfer, MD, and associates on 15 studies examining the effects of hormone therapy on coronary heart disease (CHD) found that the relative risk of estrogen therapy on the disease was 0.50 (95% confidence interval, 0.43-0.56) after adjusting for only prospective and angiographic studies (Prev Med. 1991;20[1]:47-63).

A second paper by Deborah Grady, MD, MPH, and associates found that hormone therapy with estrogen plus progestin decreased the risk of CHD and hip fracture in women but increased the risk of endometrial and breast cancer, and carried a recommendation for using estrogen plus progestin for women who have received a hysterectomy or who are at high risk for CHD (Ann Intern Med. 1992 Dec 15;117[12]:1016-37).

In the early 2000s, data from the Women’s Health Initiative (WHI) began to show a different story: Therapy with estrogen plus progestin was shown to carry risks of early harm in postmenopausal women, and one study by JoAnn E. Manson, MD, DrPH, and associates had a hazard ratio of 1.24 (nominal 95% confidence interval, 1.00-1.54) for CHD in postmenopausal women aged 50-79 years receiving the combined therapy (N Engl J Med. 2003;349:523-34).

The confidence intervals were later adjusted so the association was not significant, but the results led to conclusions that hormone therapy was harmful to women and increased risk of breast cancer, declining cognition, and dementia, as well as cardiovascular diseases such as coronary disease, stroke and thrombosis.

“That was the dogma for many people to this day, but it was clearly a rush to judgment,” said Dr. Lobo. “More harm than good was done for the field.”

The contradictory findings from the WHI and other studies may be explained by the timing of hormone therapy, Dr. Lobo explained. In the ELITE trial, 643 postmenopausal women, stratified into early-postmenopausal (less than 6 years) and late-postmenopausal (equal to or greater than 10 years) groups, received 1 mg of daily oral 17-beta-estradiol with 45 mg of progesterone vaginal gel or placebo. Researchers found that it was beneficial for preventing the progression of subclinical atherosclerosis when therapy was initiated in early but not in late menopause (N Eng J Med. 2016; 374:1221-31).

Estrogen also has benefits for the brain, and might help improve rates of cognitive decline and Alzheimer’s disease in postmenopausal women, Dr. Lobo said. Of the 1,768 women in the Cache County Study who described their use of hormone therapy after menopause, 176 women developed Alzheimer’s; however, use of hormone therapy within 5 years of menopause was associated with a 30% reduced risk of Alzheimer’s (95% confidence interval, 0.49-0.99) and had better benefits for long-term use up to 10 years. But this effect was not present in women who started hormone therapy 5 years or more after onset of menopause (Neurology. 2012 Oct 30. doi: 10.1212/WNL.0b013e318271f823).

Clinicians also should look at the risk of hormone therapy in terms of absolute real risk rather than relative risk. “In WHI, even though many of these events were not statistically significant, even if they assumed they were, the absolute numbers were 7-8 events per 10,000 women per year,” he said. “Those, according to WHI, are rare events if they’re even true.”

“For breast cancer, which is a big concern a lot of women have, endogenous risk factors are much higher than what hormones do,” he added.

Yet clinicians continue to act on data from the WHI, Dr. Lobo noted. In fact, many ob.gyns. report that they are uncomfortable treating women with symptoms associated with menopause.

“Post WHI, we have lost at least a generation of providers who do not deal with menopause,” he added. “Three out of four women who seek help for symptoms don’t receive it. The practice of menopause has largely disappeared from for many, many practices.”

The American Society for Reproductive Medicine used to have a “menopause day,” but the society no longer offers a track for menopause, Dr. Lobo said. One solution aimed at addressing the absence of training might be a menopause curriculum for ob.gyn. residents to help them initiate prevention strategies for postmenopausal women and have the confidence to manage this patient population. Dr. Lobo cited one study from Johns Hopkins where ob.gyn. residents underwent a 2-year menopause medicine curriculum and scored significantly higher on posttest scores after completing the program (78.7% vs. 57.3%; P less than .05). After the curriculum, 85.7% also reported they were more comfortable treating patients with menopause (Menopause. 2016 Mar. 23[3]:275-9).

Work also needs to be done on the front of understanding which hormone therapies are most effective for postmenopausal women. While there is currently no one hormone therapy to specifically recommend, in the future, pharmacogenetics and genetic or molecular risk analyses will play a role in knowing which products to prescribe. “It can be done, to be able to have a clear path for longevity and improved quality of life,” Dr. Lobo said.

Dr. Lobo reported serving as a consultant to Amgen, Mithra, Sojournix, and TherapeuticsMD. In addition, his institution is receiving support from Bayer and the National Institutes of Health for a clinical trial.

PHILADELPHIA – Women who underwent either hysterectomy or myomectomy had similar short-term outcomes between 6 weeks and 12 weeks after surgery despite different baseline characteristics, according to recent results from the COMPARE-UF study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Both hysterectomy and myomectomy can substantially improve women’s quality of life scores and substantially reduce symptom severity,” reported Wanda K. Nicholson, MD, MPH, lead investigator for COMPARE-UF and professor of general obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Researchers included 1,295 women in the COMPARE-UF study who were at least 30 years old, not attempting pregnancy, and undergoing hysterectomy or myomectomy for treatment of fibroids. Overall, 727 patients underwent hysterectomy, and 568 patients underwent myomectomy.

The researchers measured QoL and symptom severity using the Uterine Fibroid Scale-QoL, the EQ-5D, and Visual Analog Scale (VAS). The UFS-QoL contained subscales for concern, activities, energy and mood, control, self-consciousness, and sexual function, while the EQ-5D had subscales for mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

After surgery, UFS-QoL overall scores were similar in both hysterectomy and myomectomy groups between 6 weeks and 12 weeks (77 vs. 76), but there was less postsurgery symptom severity in the hysterectomy group over the same time period (16 vs. 20; P less than .05). However, both groups had a significant improvement in overall UFS-QoL post surgery (hysterectomy, 31; myomectomy, 30) and in UFS-QoL symptom severity (hysterectomy, 41; myomectomy, 37), Dr. Nicholson noted. EQ-5D VAS scores also were similar in both hysterectomy and myomectomy groups after treatment (82 vs. 79), and showed a 10.9 score improvement in hysterectomy patients and an 8.6 score improvement in myomectomy patients.

“This is really important, because it shows that, regardless of which procedure that you’ve chosen, at least at short-term follow up, it appears that you will have improvement in quality of life,” she said.

When researchers analyzed the UFS-QoL subscale scores, they found patients who underwent abdominal myomectomy scored better than abdominal hysterectomy on the activities subscale (79 vs. 72; P equals .01) and energy/mood subscale (82 vs. 75; P equals .03). In examining minimally invasive procedures, Dr. Nicholson and colleagues found higher improvements in health-related QoL scores among patients undergoing minimally invasive hysterectomy (45-80 vs. 45 vs. 75), and these patients also had lower symptom severity, compared with patients who underwent myomectomy (59-13 vs. 58-21).

“At least at the short-term follow-up, we think that some of that difference that we see in minimally invasive procedures vs. nonminimally invasive may be in part due to women’s perceptions or what their expectations are having minimally invasive surgery, and how they might feel in the short-term follow-up period,” said Dr. Nicholson.

These similar short-term outcomes occurred even though there were significant differences in baseline patient characteristics for the hysterectomy and myomectomy groups, with women undergoing hysterectomy being significantly younger (40 years) than patients undergoing hysterectomy (45 years). Differences also were significant between hysterectomy and myomectomy groups in the percentage of patients who were white (50% vs. 41%; P less than .01), African-American (38% vs. 41%; P less than .01) or other races (12% vs. 18%; P less than .01). There also were significant differences in baseline body mass index between hysterectomy (31 kg/m²) and myomectomy (29 kg/m²) groups.

Patients in both groups further differed in presurgery quality-of-life (QoL) scores.

Women in the hysterectomy group had lower presurgery overall QoL (44 vs. 50), greater symptom severity (60 vs. 52), and lower VAS (69 vs. 73) scores, compared with the myomectomy group (P less than .05). This difference continued in the UFS-QoL subscale scores, where women in the hysterectomy group had significantly lower scores in the concern (38 vs. 45), activities (46 vs. 52), energy/mood (45 vs. 51), control (48 vs. 52), self-consciousness (41 vs. 50), and sexual function (45 vs. 50) subscales, compared with women in the myomectomy group (P less than .05). The researchers used propensity scoring to adjust for baseline characteristics, and inverse propensity weighting to adjust for potential confounding in the multivariate analysis.

COMPARE-UF is funded by the Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), and the National Institutes of Health. Dr. Nicholson reported no relevant conflicts of interest.

SOURCE: Nicholson WK et al. ASRM 2019, Abstract SYT07.

PHILADELPHIA – Women who underwent either hysterectomy or myomectomy had similar short-term outcomes between 6 weeks and 12 weeks after surgery despite different baseline characteristics, according to recent results from the COMPARE-UF study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Both hysterectomy and myomectomy can substantially improve women’s quality of life scores and substantially reduce symptom severity,” reported Wanda K. Nicholson, MD, MPH, lead investigator for COMPARE-UF and professor of general obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Researchers included 1,295 women in the COMPARE-UF study who were at least 30 years old, not attempting pregnancy, and undergoing hysterectomy or myomectomy for treatment of fibroids. Overall, 727 patients underwent hysterectomy, and 568 patients underwent myomectomy.

The researchers measured QoL and symptom severity using the Uterine Fibroid Scale-QoL, the EQ-5D, and Visual Analog Scale (VAS). The UFS-QoL contained subscales for concern, activities, energy and mood, control, self-consciousness, and sexual function, while the EQ-5D had subscales for mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

After surgery, UFS-QoL overall scores were similar in both hysterectomy and myomectomy groups between 6 weeks and 12 weeks (77 vs. 76), but there was less postsurgery symptom severity in the hysterectomy group over the same time period (16 vs. 20; P less than .05). However, both groups had a significant improvement in overall UFS-QoL post surgery (hysterectomy, 31; myomectomy, 30) and in UFS-QoL symptom severity (hysterectomy, 41; myomectomy, 37), Dr. Nicholson noted. EQ-5D VAS scores also were similar in both hysterectomy and myomectomy groups after treatment (82 vs. 79), and showed a 10.9 score improvement in hysterectomy patients and an 8.6 score improvement in myomectomy patients.

“This is really important, because it shows that, regardless of which procedure that you’ve chosen, at least at short-term follow up, it appears that you will have improvement in quality of life,” she said.

When researchers analyzed the UFS-QoL subscale scores, they found patients who underwent abdominal myomectomy scored better than abdominal hysterectomy on the activities subscale (79 vs. 72; P equals .01) and energy/mood subscale (82 vs. 75; P equals .03). In examining minimally invasive procedures, Dr. Nicholson and colleagues found higher improvements in health-related QoL scores among patients undergoing minimally invasive hysterectomy (45-80 vs. 45 vs. 75), and these patients also had lower symptom severity, compared with patients who underwent myomectomy (59-13 vs. 58-21).

“At least at the short-term follow-up, we think that some of that difference that we see in minimally invasive procedures vs. nonminimally invasive may be in part due to women’s perceptions or what their expectations are having minimally invasive surgery, and how they might feel in the short-term follow-up period,” said Dr. Nicholson.

These similar short-term outcomes occurred even though there were significant differences in baseline patient characteristics for the hysterectomy and myomectomy groups, with women undergoing hysterectomy being significantly younger (40 years) than patients undergoing hysterectomy (45 years). Differences also were significant between hysterectomy and myomectomy groups in the percentage of patients who were white (50% vs. 41%; P less than .01), African-American (38% vs. 41%; P less than .01) or other races (12% vs. 18%; P less than .01). There also were significant differences in baseline body mass index between hysterectomy (31 kg/m²) and myomectomy (29 kg/m²) groups.

Patients in both groups further differed in presurgery quality-of-life (QoL) scores.

Women in the hysterectomy group had lower presurgery overall QoL (44 vs. 50), greater symptom severity (60 vs. 52), and lower VAS (69 vs. 73) scores, compared with the myomectomy group (P less than .05). This difference continued in the UFS-QoL subscale scores, where women in the hysterectomy group had significantly lower scores in the concern (38 vs. 45), activities (46 vs. 52), energy/mood (45 vs. 51), control (48 vs. 52), self-consciousness (41 vs. 50), and sexual function (45 vs. 50) subscales, compared with women in the myomectomy group (P less than .05). The researchers used propensity scoring to adjust for baseline characteristics, and inverse propensity weighting to adjust for potential confounding in the multivariate analysis.

COMPARE-UF is funded by the Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), and the National Institutes of Health. Dr. Nicholson reported no relevant conflicts of interest.

SOURCE: Nicholson WK et al. ASRM 2019, Abstract SYT07.

PHILADELPHIA – Women who underwent either hysterectomy or myomectomy had similar short-term outcomes between 6 weeks and 12 weeks after surgery despite different baseline characteristics, according to recent results from the COMPARE-UF study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Both hysterectomy and myomectomy can substantially improve women’s quality of life scores and substantially reduce symptom severity,” reported Wanda K. Nicholson, MD, MPH, lead investigator for COMPARE-UF and professor of general obstetrics and gynecology at the University of North Carolina at Chapel Hill.

Researchers included 1,295 women in the COMPARE-UF study who were at least 30 years old, not attempting pregnancy, and undergoing hysterectomy or myomectomy for treatment of fibroids. Overall, 727 patients underwent hysterectomy, and 568 patients underwent myomectomy.

The researchers measured QoL and symptom severity using the Uterine Fibroid Scale-QoL, the EQ-5D, and Visual Analog Scale (VAS). The UFS-QoL contained subscales for concern, activities, energy and mood, control, self-consciousness, and sexual function, while the EQ-5D had subscales for mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

After surgery, UFS-QoL overall scores were similar in both hysterectomy and myomectomy groups between 6 weeks and 12 weeks (77 vs. 76), but there was less postsurgery symptom severity in the hysterectomy group over the same time period (16 vs. 20; P less than .05). However, both groups had a significant improvement in overall UFS-QoL post surgery (hysterectomy, 31; myomectomy, 30) and in UFS-QoL symptom severity (hysterectomy, 41; myomectomy, 37), Dr. Nicholson noted. EQ-5D VAS scores also were similar in both hysterectomy and myomectomy groups after treatment (82 vs. 79), and showed a 10.9 score improvement in hysterectomy patients and an 8.6 score improvement in myomectomy patients.

“This is really important, because it shows that, regardless of which procedure that you’ve chosen, at least at short-term follow up, it appears that you will have improvement in quality of life,” she said.

When researchers analyzed the UFS-QoL subscale scores, they found patients who underwent abdominal myomectomy scored better than abdominal hysterectomy on the activities subscale (79 vs. 72; P equals .01) and energy/mood subscale (82 vs. 75; P equals .03). In examining minimally invasive procedures, Dr. Nicholson and colleagues found higher improvements in health-related QoL scores among patients undergoing minimally invasive hysterectomy (45-80 vs. 45 vs. 75), and these patients also had lower symptom severity, compared with patients who underwent myomectomy (59-13 vs. 58-21).

“At least at the short-term follow-up, we think that some of that difference that we see in minimally invasive procedures vs. nonminimally invasive may be in part due to women’s perceptions or what their expectations are having minimally invasive surgery, and how they might feel in the short-term follow-up period,” said Dr. Nicholson.

These similar short-term outcomes occurred even though there were significant differences in baseline patient characteristics for the hysterectomy and myomectomy groups, with women undergoing hysterectomy being significantly younger (40 years) than patients undergoing hysterectomy (45 years). Differences also were significant between hysterectomy and myomectomy groups in the percentage of patients who were white (50% vs. 41%; P less than .01), African-American (38% vs. 41%; P less than .01) or other races (12% vs. 18%; P less than .01). There also were significant differences in baseline body mass index between hysterectomy (31 kg/m²) and myomectomy (29 kg/m²) groups.

Patients in both groups further differed in presurgery quality-of-life (QoL) scores.

Women in the hysterectomy group had lower presurgery overall QoL (44 vs. 50), greater symptom severity (60 vs. 52), and lower VAS (69 vs. 73) scores, compared with the myomectomy group (P less than .05). This difference continued in the UFS-QoL subscale scores, where women in the hysterectomy group had significantly lower scores in the concern (38 vs. 45), activities (46 vs. 52), energy/mood (45 vs. 51), control (48 vs. 52), self-consciousness (41 vs. 50), and sexual function (45 vs. 50) subscales, compared with women in the myomectomy group (P less than .05). The researchers used propensity scoring to adjust for baseline characteristics, and inverse propensity weighting to adjust for potential confounding in the multivariate analysis.

COMPARE-UF is funded by the Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), and the National Institutes of Health. Dr. Nicholson reported no relevant conflicts of interest.

SOURCE: Nicholson WK et al. ASRM 2019, Abstract SYT07.

PHILADELPHIA – A multidisciplinary approach is needed to care for gender-diverse transgender adolescents interested in fertility preservation, Leena Nahata, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Counseling transgender youth about fertility preservation creates a number of clinical and ethical challenges for pediatric providers, especially in the absence of longitudinal data, said Dr. Nahata, medical director of the fertility and reproductive health program at Nationwide Children’s Hospital, Columbus, Ohio. “We’re trying to counsel these youth and their parents about long-term outcomes of hormone therapies. However, despite the lack of data, not treating them also is not a viable option.”

Another concern among transgender individuals, Dr. Nahata said, is a high risk of mental health issues. Approximately one-third of transgender individuals experience depression, and between one-third and one-half have suicidal ideation or attempted suicide.

“It’s important to realize that these risks are not inevitable,” she said. Support from parents, peers, and social groups; engaging with the health care system; and having access to puberty suppression, gender-affirming hormones, and surgery are protective outcomes for mental health concerns. “It’s because of this that so many of us feel obligated to move on with treatments even in a setting of a lack of data.”

According to 2017 guidelines from the Endocrine Society on gender-dysphoric and gender-incongruent persons, patients can begin gonadotropin-releasing hormone (GnRH) agonists at Tanner Stage 2 of puberty (J Clin Endocrinol Metab. 2017 Nov. doi: 10.1210/jc.2017-01658). Before starting treatment, a mental health provider should confirm gender dysphoria or incongruence, and determine whether the patient has “sufficient mental capacity” to understand the long-term consequences of treatment with gender-affirming hormones such as estrogen and testosterone because the effects are partially irreversible, including a potential loss of fertility. Most pediatric patients will have this ability by 16 years old, but some programs across the country begin treatment between 13.5 years and 14 years of age, said Dr. Nahata. One consideration of beginning GnRH agonists and then moving directly to gender-affirming hormone therapy, there may not be an opportunity to explore fertility preservation.

Dr. Nahata acknowledged the data for the long-term effects of testosterone and estrogen on fertility is “murky,” but despite a lack of data, the American Society for Reproductive Medicine released an ethics statement in 2015 affirming that transgender patients “have the same interests as other persons in having children and in accessing fertility services for fertility preservation and reproduction” and pediatric providers “should offer fertility preservation options to individuals before gender transition” (Fertil Steril. 2015 Sep 9. doi: 10.1016/j.fertnstert.2015.08.021).

There also is mixed evidence that transgender individuals take advantage of fertility preservation services, whether offered or not. Two studies from Belgium that surveyed transgender individuals on parenthood preferences found 54% of adult trans men had a desire for children and that 38% of adult trans men and 51% of adult trans women would consider fertility preservation if it was an option. However, Dr. Nahata said a retrospective study from her own group of 50 adolescent trans males and 23 adolescent trans females found 99% of the cohort was counseled on fertility preservation, but only 3% (2 patients) attempted fertility preservation, and both were trans females (J Adolesc Health. 2017 Jul. doi: 10.1016/j.jadohealth.2016.12.012).

Another study examining use of fertility preservation in trans females in the Netherlands by Brik et al. found a much higher use of fertility preservation, with 38% of patients attempting cryopreservation after counseling (J Adolesc Health. 2019 May. doi: 10.1016/j.jadohealth.2018.11.008). “It’s unclear whether this is a regional difference or whether things are actually shifting over a short period of time,” said Dr. Nahata.

Attitudes about fertility preservation among gender-diverse transgender youth also impact its use in this patient population. A survey of transgender youth found less than 40% preferred adoption to biological parenthood, but said their feelings might change as time passes. However, more than half wanted more information on their family-building options. For other transgender youth aged 12-19 years, having children was their “lowest life priority,” compared with having friends, their health, and other issues in their lives, said Dr. Nahata.

In a 24-item survey Dr. Nahata and her team administered to 44 trans nonbinary adolescents, the most common reasons for not seeking fertility preservation were feelings of being too young, not wanting to be a parent or have a biological child, not wanting to delay treatment, and not being able to afford the cost of fertility preservation.

“This just speaks to the complexities of counseling in this population, and the importance of having a multidisciplinary team to see these youth and families to do more comprehensive counseling,” she said.

Dr. Nahata reported no relevant conflicts of interest.

PHILADELPHIA – A multidisciplinary approach is needed to care for gender-diverse transgender adolescents interested in fertility preservation, Leena Nahata, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Counseling transgender youth about fertility preservation creates a number of clinical and ethical challenges for pediatric providers, especially in the absence of longitudinal data, said Dr. Nahata, medical director of the fertility and reproductive health program at Nationwide Children’s Hospital, Columbus, Ohio. “We’re trying to counsel these youth and their parents about long-term outcomes of hormone therapies. However, despite the lack of data, not treating them also is not a viable option.”

Another concern among transgender individuals, Dr. Nahata said, is a high risk of mental health issues. Approximately one-third of transgender individuals experience depression, and between one-third and one-half have suicidal ideation or attempted suicide.

“It’s important to realize that these risks are not inevitable,” she said. Support from parents, peers, and social groups; engaging with the health care system; and having access to puberty suppression, gender-affirming hormones, and surgery are protective outcomes for mental health concerns. “It’s because of this that so many of us feel obligated to move on with treatments even in a setting of a lack of data.”

According to 2017 guidelines from the Endocrine Society on gender-dysphoric and gender-incongruent persons, patients can begin gonadotropin-releasing hormone (GnRH) agonists at Tanner Stage 2 of puberty (J Clin Endocrinol Metab. 2017 Nov. doi: 10.1210/jc.2017-01658). Before starting treatment, a mental health provider should confirm gender dysphoria or incongruence, and determine whether the patient has “sufficient mental capacity” to understand the long-term consequences of treatment with gender-affirming hormones such as estrogen and testosterone because the effects are partially irreversible, including a potential loss of fertility. Most pediatric patients will have this ability by 16 years old, but some programs across the country begin treatment between 13.5 years and 14 years of age, said Dr. Nahata. One consideration of beginning GnRH agonists and then moving directly to gender-affirming hormone therapy, there may not be an opportunity to explore fertility preservation.

Dr. Nahata acknowledged the data for the long-term effects of testosterone and estrogen on fertility is “murky,” but despite a lack of data, the American Society for Reproductive Medicine released an ethics statement in 2015 affirming that transgender patients “have the same interests as other persons in having children and in accessing fertility services for fertility preservation and reproduction” and pediatric providers “should offer fertility preservation options to individuals before gender transition” (Fertil Steril. 2015 Sep 9. doi: 10.1016/j.fertnstert.2015.08.021).

There also is mixed evidence that transgender individuals take advantage of fertility preservation services, whether offered or not. Two studies from Belgium that surveyed transgender individuals on parenthood preferences found 54% of adult trans men had a desire for children and that 38% of adult trans men and 51% of adult trans women would consider fertility preservation if it was an option. However, Dr. Nahata said a retrospective study from her own group of 50 adolescent trans males and 23 adolescent trans females found 99% of the cohort was counseled on fertility preservation, but only 3% (2 patients) attempted fertility preservation, and both were trans females (J Adolesc Health. 2017 Jul. doi: 10.1016/j.jadohealth.2016.12.012).

Another study examining use of fertility preservation in trans females in the Netherlands by Brik et al. found a much higher use of fertility preservation, with 38% of patients attempting cryopreservation after counseling (J Adolesc Health. 2019 May. doi: 10.1016/j.jadohealth.2018.11.008). “It’s unclear whether this is a regional difference or whether things are actually shifting over a short period of time,” said Dr. Nahata.

Attitudes about fertility preservation among gender-diverse transgender youth also impact its use in this patient population. A survey of transgender youth found less than 40% preferred adoption to biological parenthood, but said their feelings might change as time passes. However, more than half wanted more information on their family-building options. For other transgender youth aged 12-19 years, having children was their “lowest life priority,” compared with having friends, their health, and other issues in their lives, said Dr. Nahata.

In a 24-item survey Dr. Nahata and her team administered to 44 trans nonbinary adolescents, the most common reasons for not seeking fertility preservation were feelings of being too young, not wanting to be a parent or have a biological child, not wanting to delay treatment, and not being able to afford the cost of fertility preservation.

“This just speaks to the complexities of counseling in this population, and the importance of having a multidisciplinary team to see these youth and families to do more comprehensive counseling,” she said.

Dr. Nahata reported no relevant conflicts of interest.

PHILADELPHIA – A multidisciplinary approach is needed to care for gender-diverse transgender adolescents interested in fertility preservation, Leena Nahata, MD, said at the annual meeting of the American Society for Reproductive Medicine.

Counseling transgender youth about fertility preservation creates a number of clinical and ethical challenges for pediatric providers, especially in the absence of longitudinal data, said Dr. Nahata, medical director of the fertility and reproductive health program at Nationwide Children’s Hospital, Columbus, Ohio. “We’re trying to counsel these youth and their parents about long-term outcomes of hormone therapies. However, despite the lack of data, not treating them also is not a viable option.”

Another concern among transgender individuals, Dr. Nahata said, is a high risk of mental health issues. Approximately one-third of transgender individuals experience depression, and between one-third and one-half have suicidal ideation or attempted suicide.

“It’s important to realize that these risks are not inevitable,” she said. Support from parents, peers, and social groups; engaging with the health care system; and having access to puberty suppression, gender-affirming hormones, and surgery are protective outcomes for mental health concerns. “It’s because of this that so many of us feel obligated to move on with treatments even in a setting of a lack of data.”

According to 2017 guidelines from the Endocrine Society on gender-dysphoric and gender-incongruent persons, patients can begin gonadotropin-releasing hormone (GnRH) agonists at Tanner Stage 2 of puberty (J Clin Endocrinol Metab. 2017 Nov. doi: 10.1210/jc.2017-01658). Before starting treatment, a mental health provider should confirm gender dysphoria or incongruence, and determine whether the patient has “sufficient mental capacity” to understand the long-term consequences of treatment with gender-affirming hormones such as estrogen and testosterone because the effects are partially irreversible, including a potential loss of fertility. Most pediatric patients will have this ability by 16 years old, but some programs across the country begin treatment between 13.5 years and 14 years of age, said Dr. Nahata. One consideration of beginning GnRH agonists and then moving directly to gender-affirming hormone therapy, there may not be an opportunity to explore fertility preservation.

Dr. Nahata acknowledged the data for the long-term effects of testosterone and estrogen on fertility is “murky,” but despite a lack of data, the American Society for Reproductive Medicine released an ethics statement in 2015 affirming that transgender patients “have the same interests as other persons in having children and in accessing fertility services for fertility preservation and reproduction” and pediatric providers “should offer fertility preservation options to individuals before gender transition” (Fertil Steril. 2015 Sep 9. doi: 10.1016/j.fertnstert.2015.08.021).

There also is mixed evidence that transgender individuals take advantage of fertility preservation services, whether offered or not. Two studies from Belgium that surveyed transgender individuals on parenthood preferences found 54% of adult trans men had a desire for children and that 38% of adult trans men and 51% of adult trans women would consider fertility preservation if it was an option. However, Dr. Nahata said a retrospective study from her own group of 50 adolescent trans males and 23 adolescent trans females found 99% of the cohort was counseled on fertility preservation, but only 3% (2 patients) attempted fertility preservation, and both were trans females (J Adolesc Health. 2017 Jul. doi: 10.1016/j.jadohealth.2016.12.012).

Another study examining use of fertility preservation in trans females in the Netherlands by Brik et al. found a much higher use of fertility preservation, with 38% of patients attempting cryopreservation after counseling (J Adolesc Health. 2019 May. doi: 10.1016/j.jadohealth.2018.11.008). “It’s unclear whether this is a regional difference or whether things are actually shifting over a short period of time,” said Dr. Nahata.

Attitudes about fertility preservation among gender-diverse transgender youth also impact its use in this patient population. A survey of transgender youth found less than 40% preferred adoption to biological parenthood, but said their feelings might change as time passes. However, more than half wanted more information on their family-building options. For other transgender youth aged 12-19 years, having children was their “lowest life priority,” compared with having friends, their health, and other issues in their lives, said Dr. Nahata.

In a 24-item survey Dr. Nahata and her team administered to 44 trans nonbinary adolescents, the most common reasons for not seeking fertility preservation were feelings of being too young, not wanting to be a parent or have a biological child, not wanting to delay treatment, and not being able to afford the cost of fertility preservation.

“This just speaks to the complexities of counseling in this population, and the importance of having a multidisciplinary team to see these youth and families to do more comprehensive counseling,” she said.

Dr. Nahata reported no relevant conflicts of interest.

PHILADELPHIA – Ovarian tissue cryopreservation should no longer be considered experimental, Sherman J. Silber, MD, said at the annual meeting of the American Society for Reproductive Medicine.

That claim is based on more than 20 years of experience at his center performing the procedure and results he presented from patients for whom frozen ovarian tissue has been reimplanted resulting in a spontaneous pregnancy.

“For prepubertal girls with cancer and for patients who have already had a preliminary round of chemotherapy, ovarian tissue freezing is the only method available to preserve their fertility,” said Dr. Silber, of the Infertility Center of St. Louis in Chesterfield, Missouri. “It is also the only method available to preserve their fertility.”

“I have very strong feelings about this,” he added. “It has huge societal implications for insurance payments.”

Dr. Silber presented results of ovarian tissue freezing and reimplantation at his center beginning in 1997, where 115 patients between the ages of 2 and 35 years underwent the procedure using the same technique. Of these patients, 14 women came back years later to have their frozen ovary cortex reimplanted. Dr. Silber and his group followed these patients monthly for more than 2 years after reimplantation for signs of return of menses, hormonal changes, pregnancy, and live birth.

Most of the patients who chose ovarian tissue freezing had cancer. Eight patients underwent the procedure after being diagnosed with solid tissue cancer and three had leukemia, while two patients underwent ovarian tissue freezing due to premature ovarian failure, and one because of multiple sclerosis. Patients who underwent reimplantation were menopausal for at least 3 years, said Dr. Silber.

Dr. Silber also described the technique used for reimplantation. After the cortical tissue was thawed, the tissue was quilted into one piece from three to five slices using 9-0 nylon interrupted sutures. The quilted tissue was then sutured to the medulla after the surgeon completely removed the dead cortex from the other ovary. “Hemostasis was achieved with micro bipolar forceps,” said Dr. Silber. “Constant irrigation was employed with pulsed heparinized media because we wanted to avoid adhesions, and we wanted to try for spontaneous pregnancy rather than IVF.”

“Then, we put [the quilted ovarian slices] on to the medulla on the other side in such a way that the fallopian tube would be able to reach and catch any egg that’s ovulated during that time,” he added.

Dr. Silber and his group found that, over time, follicle-stimulating hormone (FSH) levels sharply decreased to normal or near-normal levels between 69 days and 133 days after the procedure while Anti-Müllerian hormone (AMH) levels dramatically rose to higher levels between 133 days and 227 days post-procedure before dropping to very low levels, “and the AMH remained at low levels despite the fact that [transplants] would last 8 to 10 years,” said Dr. Silber.

Of the 14 cases where frozen ovarian tissue was reimplanted, 11 patients (78%) achieved pregnancy, 10 patients (71%) delivered healthy babies, and 1 patient (9%) experienced a miscarriage. All patients had spontaneous pregnancies, and none used in vitro fertilization (IVF), noted Dr. Silber. There were 2 patients who had four children from transplanted ovarian tissue, and 2 of 3 patients with leukemia had a total of five children.

Additionally, Dr. Silber’s group examined the literature for other examples of ovarian tissue reimplantation after cryopreservation to determine how many live births resulted from the procedure. They found an additional 170 live births in addition to the 15 live births at their center, with a pregnancy rate ranging from 31% to 71% in different studies. Cancer was not transmitted from mother to child in any case, said Dr. Silber.

Compared with egg freezing, there is a benefit to performing ovarian tissue freezing, even after chemotherapy has begun, noted Dr. Silber. The cost of ovarian tissue freezing is also roughly one-tenth that of egg freezing, and the procedure is less burdensome than multiple cycles with the potential for ovarian hyperstimulation, and it restores the hormone function and the fertility of eggs after reimplantation.

“Because the greater primordial follicle recruitment decreases as the ovarian reserve decreases, you can put a piece of ovary tissue back every 8 years, and a woman can have endocrine function until she’s 100 years old,” said Dr. Silber.

Dr. Silber reported no relevant conflicts of interest.

obnews@mdedge.com

SOURCE: Silber SJ. ASRM 2019. Abstract O-203.

PHILADELPHIA – Ovarian tissue cryopreservation should no longer be considered experimental, Sherman J. Silber, MD, said at the annual meeting of the American Society for Reproductive Medicine.

That claim is based on more than 20 years of experience at his center performing the procedure and results he presented from patients for whom frozen ovarian tissue has been reimplanted resulting in a spontaneous pregnancy.

“For prepubertal girls with cancer and for patients who have already had a preliminary round of chemotherapy, ovarian tissue freezing is the only method available to preserve their fertility,” said Dr. Silber, of the Infertility Center of St. Louis in Chesterfield, Missouri. “It is also the only method available to preserve their fertility.”

“I have very strong feelings about this,” he added. “It has huge societal implications for insurance payments.”

Dr. Silber presented results of ovarian tissue freezing and reimplantation at his center beginning in 1997, where 115 patients between the ages of 2 and 35 years underwent the procedure using the same technique. Of these patients, 14 women came back years later to have their frozen ovary cortex reimplanted. Dr. Silber and his group followed these patients monthly for more than 2 years after reimplantation for signs of return of menses, hormonal changes, pregnancy, and live birth.

Most of the patients who chose ovarian tissue freezing had cancer. Eight patients underwent the procedure after being diagnosed with solid tissue cancer and three had leukemia, while two patients underwent ovarian tissue freezing due to premature ovarian failure, and one because of multiple sclerosis. Patients who underwent reimplantation were menopausal for at least 3 years, said Dr. Silber.

Dr. Silber also described the technique used for reimplantation. After the cortical tissue was thawed, the tissue was quilted into one piece from three to five slices using 9-0 nylon interrupted sutures. The quilted tissue was then sutured to the medulla after the surgeon completely removed the dead cortex from the other ovary. “Hemostasis was achieved with micro bipolar forceps,” said Dr. Silber. “Constant irrigation was employed with pulsed heparinized media because we wanted to avoid adhesions, and we wanted to try for spontaneous pregnancy rather than IVF.”

“Then, we put [the quilted ovarian slices] on to the medulla on the other side in such a way that the fallopian tube would be able to reach and catch any egg that’s ovulated during that time,” he added.

Dr. Silber and his group found that, over time, follicle-stimulating hormone (FSH) levels sharply decreased to normal or near-normal levels between 69 days and 133 days after the procedure while Anti-Müllerian hormone (AMH) levels dramatically rose to higher levels between 133 days and 227 days post-procedure before dropping to very low levels, “and the AMH remained at low levels despite the fact that [transplants] would last 8 to 10 years,” said Dr. Silber.

Of the 14 cases where frozen ovarian tissue was reimplanted, 11 patients (78%) achieved pregnancy, 10 patients (71%) delivered healthy babies, and 1 patient (9%) experienced a miscarriage. All patients had spontaneous pregnancies, and none used in vitro fertilization (IVF), noted Dr. Silber. There were 2 patients who had four children from transplanted ovarian tissue, and 2 of 3 patients with leukemia had a total of five children.

Additionally, Dr. Silber’s group examined the literature for other examples of ovarian tissue reimplantation after cryopreservation to determine how many live births resulted from the procedure. They found an additional 170 live births in addition to the 15 live births at their center, with a pregnancy rate ranging from 31% to 71% in different studies. Cancer was not transmitted from mother to child in any case, said Dr. Silber.

Compared with egg freezing, there is a benefit to performing ovarian tissue freezing, even after chemotherapy has begun, noted Dr. Silber. The cost of ovarian tissue freezing is also roughly one-tenth that of egg freezing, and the procedure is less burdensome than multiple cycles with the potential for ovarian hyperstimulation, and it restores the hormone function and the fertility of eggs after reimplantation.

“Because the greater primordial follicle recruitment decreases as the ovarian reserve decreases, you can put a piece of ovary tissue back every 8 years, and a woman can have endocrine function until she’s 100 years old,” said Dr. Silber.

Dr. Silber reported no relevant conflicts of interest.

obnews@mdedge.com

SOURCE: Silber SJ. ASRM 2019. Abstract O-203.

PHILADELPHIA – Ovarian tissue cryopreservation should no longer be considered experimental, Sherman J. Silber, MD, said at the annual meeting of the American Society for Reproductive Medicine.

That claim is based on more than 20 years of experience at his center performing the procedure and results he presented from patients for whom frozen ovarian tissue has been reimplanted resulting in a spontaneous pregnancy.

“For prepubertal girls with cancer and for patients who have already had a preliminary round of chemotherapy, ovarian tissue freezing is the only method available to preserve their fertility,” said Dr. Silber, of the Infertility Center of St. Louis in Chesterfield, Missouri. “It is also the only method available to preserve their fertility.”

“I have very strong feelings about this,” he added. “It has huge societal implications for insurance payments.”

Dr. Silber presented results of ovarian tissue freezing and reimplantation at his center beginning in 1997, where 115 patients between the ages of 2 and 35 years underwent the procedure using the same technique. Of these patients, 14 women came back years later to have their frozen ovary cortex reimplanted. Dr. Silber and his group followed these patients monthly for more than 2 years after reimplantation for signs of return of menses, hormonal changes, pregnancy, and live birth.

Most of the patients who chose ovarian tissue freezing had cancer. Eight patients underwent the procedure after being diagnosed with solid tissue cancer and three had leukemia, while two patients underwent ovarian tissue freezing due to premature ovarian failure, and one because of multiple sclerosis. Patients who underwent reimplantation were menopausal for at least 3 years, said Dr. Silber.

Dr. Silber also described the technique used for reimplantation. After the cortical tissue was thawed, the tissue was quilted into one piece from three to five slices using 9-0 nylon interrupted sutures. The quilted tissue was then sutured to the medulla after the surgeon completely removed the dead cortex from the other ovary. “Hemostasis was achieved with micro bipolar forceps,” said Dr. Silber. “Constant irrigation was employed with pulsed heparinized media because we wanted to avoid adhesions, and we wanted to try for spontaneous pregnancy rather than IVF.”

“Then, we put [the quilted ovarian slices] on to the medulla on the other side in such a way that the fallopian tube would be able to reach and catch any egg that’s ovulated during that time,” he added.

Dr. Silber and his group found that, over time, follicle-stimulating hormone (FSH) levels sharply decreased to normal or near-normal levels between 69 days and 133 days after the procedure while Anti-Müllerian hormone (AMH) levels dramatically rose to higher levels between 133 days and 227 days post-procedure before dropping to very low levels, “and the AMH remained at low levels despite the fact that [transplants] would last 8 to 10 years,” said Dr. Silber.

Of the 14 cases where frozen ovarian tissue was reimplanted, 11 patients (78%) achieved pregnancy, 10 patients (71%) delivered healthy babies, and 1 patient (9%) experienced a miscarriage. All patients had spontaneous pregnancies, and none used in vitro fertilization (IVF), noted Dr. Silber. There were 2 patients who had four children from transplanted ovarian tissue, and 2 of 3 patients with leukemia had a total of five children.

Additionally, Dr. Silber’s group examined the literature for other examples of ovarian tissue reimplantation after cryopreservation to determine how many live births resulted from the procedure. They found an additional 170 live births in addition to the 15 live births at their center, with a pregnancy rate ranging from 31% to 71% in different studies. Cancer was not transmitted from mother to child in any case, said Dr. Silber.

Compared with egg freezing, there is a benefit to performing ovarian tissue freezing, even after chemotherapy has begun, noted Dr. Silber. The cost of ovarian tissue freezing is also roughly one-tenth that of egg freezing, and the procedure is less burdensome than multiple cycles with the potential for ovarian hyperstimulation, and it restores the hormone function and the fertility of eggs after reimplantation.

“Because the greater primordial follicle recruitment decreases as the ovarian reserve decreases, you can put a piece of ovary tissue back every 8 years, and a woman can have endocrine function until she’s 100 years old,” said Dr. Silber.

Dr. Silber reported no relevant conflicts of interest.

obnews@mdedge.com

SOURCE: Silber SJ. ASRM 2019. Abstract O-203.

PHILADELPHIA – When the male partner used marijuana one or more times per week before conception, couples had a higher rate of spontaneous abortion, compared with infrequent use or no use of marijuana by the male partner, Alyssa F. Harlow, MPH, reported at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The male partner’s use of marijuana “one or more times per week in the past 2 months during the preconception period in our study was associated with an increased risk of spontaneous abortion,” said Ms. Harlow, a PhD candidate at Boston University. “The association attenuated for later pregnancy losses, and persisted for those with shorter [pregnancy] attempt time at [study] entry.”

Ms. Harlow and colleagues prospectively collected data from 1,535 couples in the Pregnancy Study Online (PRESTO) study, a preconception cohort study examining risk factors for adverse pregnancy outcomes. PRESTO enrolled women aged 21-45 years and their male partners aged 21 years or older who were attempting to conceive without the use of fertility treatment.

The researchers administered a screening and baseline questionnaire to the women, who then included their male partners in the study. The male partners completed their own baseline questionnaire that asked about demographics, medical history, and lifestyle or behavioral factors including marijuana use. The questions centering around marijuana use asked whether the partner had used marijuana within the past 2 months, and the frequency of marijuana use during that period.

Women in PRESTO were followed every 8 weeks until a pregnancy occurred, or up to 12 months if no pregnancy occurred. If they became pregnant, the women were asked additional questions at less than 12 weeks’ gestation and then again at 32 weeks’ gestation, including questions about any miscarriages, and how long a pregnancy lasted if a miscarriage did occur.

At baseline, 1,267 couples (83%) reported no marijuana use by male partners, 140 couples (9%) reported use less than 1 time per week, and 128 couples (8%) reported marijuana use at least 1 time per week. Men at baseline were similar in age and body mass index among groups, but men who used marijuana were more likely to be cigarette smokers (24% vs. 4%), were more likely to have partners who were cigarette smokers (11% vs. 2%), and were more likely to have partners who use marijuana (43% vs. 3%), compared with couples where the male partners did not use marijuana. Male partners who used marijuana also were less likely to be taking a daily multivitamin (25% vs. 37%), and were more likely to have been diagnosed with anxiety (14% vs. 7%) or depression (20% vs. 9%) compared with male partners who did not use marijuana.

Overall, 269 spontaneous abortions (17.5%) occurred during the study period, and couples where male partners used marijuana one or more times per week had approximately twice the rate of spontaneous abortions, compared with no marijuana use (hazard ratio, 1.99; 95% confidence interval).

Couples in which men who used marijuana less than 1 time per week had a slightly increased risk of spontaneous abortion, but this did not reach statistical significance.

When the results were adjusted for female nonusers of marijuana, the results were “essentially identical,” said Ms. Harlow.

Couples who were trying to conceive for three or fewer cycles at baseline (1,045 couples) had a lower rate of spontaneous abortion than that of couples trying for three or more cycles (490 couples). When the results were stratified by gestational age at loss, the results persisted for couples with a pregnancy loss at less than 8 weeks (1,533 couples), but the effect of marijuana use was reduced for couples with a loss at 8 weeks or more (1,113 couples).

Ms. Harlow noted several limitations to the study, including lack of data on time-varying marijuana use, potential selection bias, and residual confounding. There also is likely misclassification of exposure among some participants because marijuana use was self-reported, she added.

Ms. Harlow reported no relevant conflicts of interest.

SOURCE: Harlow AF et al. ASRM 2019. Abstract O-4.

PHILADELPHIA – When the male partner used marijuana one or more times per week before conception, couples had a higher rate of spontaneous abortion, compared with infrequent use or no use of marijuana by the male partner, Alyssa F. Harlow, MPH, reported at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The male partner’s use of marijuana “one or more times per week in the past 2 months during the preconception period in our study was associated with an increased risk of spontaneous abortion,” said Ms. Harlow, a PhD candidate at Boston University. “The association attenuated for later pregnancy losses, and persisted for those with shorter [pregnancy] attempt time at [study] entry.”

Ms. Harlow and colleagues prospectively collected data from 1,535 couples in the Pregnancy Study Online (PRESTO) study, a preconception cohort study examining risk factors for adverse pregnancy outcomes. PRESTO enrolled women aged 21-45 years and their male partners aged 21 years or older who were attempting to conceive without the use of fertility treatment.

The researchers administered a screening and baseline questionnaire to the women, who then included their male partners in the study. The male partners completed their own baseline questionnaire that asked about demographics, medical history, and lifestyle or behavioral factors including marijuana use. The questions centering around marijuana use asked whether the partner had used marijuana within the past 2 months, and the frequency of marijuana use during that period.

Women in PRESTO were followed every 8 weeks until a pregnancy occurred, or up to 12 months if no pregnancy occurred. If they became pregnant, the women were asked additional questions at less than 12 weeks’ gestation and then again at 32 weeks’ gestation, including questions about any miscarriages, and how long a pregnancy lasted if a miscarriage did occur.

At baseline, 1,267 couples (83%) reported no marijuana use by male partners, 140 couples (9%) reported use less than 1 time per week, and 128 couples (8%) reported marijuana use at least 1 time per week. Men at baseline were similar in age and body mass index among groups, but men who used marijuana were more likely to be cigarette smokers (24% vs. 4%), were more likely to have partners who were cigarette smokers (11% vs. 2%), and were more likely to have partners who use marijuana (43% vs. 3%), compared with couples where the male partners did not use marijuana. Male partners who used marijuana also were less likely to be taking a daily multivitamin (25% vs. 37%), and were more likely to have been diagnosed with anxiety (14% vs. 7%) or depression (20% vs. 9%) compared with male partners who did not use marijuana.

Overall, 269 spontaneous abortions (17.5%) occurred during the study period, and couples where male partners used marijuana one or more times per week had approximately twice the rate of spontaneous abortions, compared with no marijuana use (hazard ratio, 1.99; 95% confidence interval).

Couples in which men who used marijuana less than 1 time per week had a slightly increased risk of spontaneous abortion, but this did not reach statistical significance.

When the results were adjusted for female nonusers of marijuana, the results were “essentially identical,” said Ms. Harlow.

Couples who were trying to conceive for three or fewer cycles at baseline (1,045 couples) had a lower rate of spontaneous abortion than that of couples trying for three or more cycles (490 couples). When the results were stratified by gestational age at loss, the results persisted for couples with a pregnancy loss at less than 8 weeks (1,533 couples), but the effect of marijuana use was reduced for couples with a loss at 8 weeks or more (1,113 couples).

Ms. Harlow noted several limitations to the study, including lack of data on time-varying marijuana use, potential selection bias, and residual confounding. There also is likely misclassification of exposure among some participants because marijuana use was self-reported, she added.

Ms. Harlow reported no relevant conflicts of interest.

SOURCE: Harlow AF et al. ASRM 2019. Abstract O-4.

PHILADELPHIA – When the male partner used marijuana one or more times per week before conception, couples had a higher rate of spontaneous abortion, compared with infrequent use or no use of marijuana by the male partner, Alyssa F. Harlow, MPH, reported at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The male partner’s use of marijuana “one or more times per week in the past 2 months during the preconception period in our study was associated with an increased risk of spontaneous abortion,” said Ms. Harlow, a PhD candidate at Boston University. “The association attenuated for later pregnancy losses, and persisted for those with shorter [pregnancy] attempt time at [study] entry.”

Ms. Harlow and colleagues prospectively collected data from 1,535 couples in the Pregnancy Study Online (PRESTO) study, a preconception cohort study examining risk factors for adverse pregnancy outcomes. PRESTO enrolled women aged 21-45 years and their male partners aged 21 years or older who were attempting to conceive without the use of fertility treatment.

The researchers administered a screening and baseline questionnaire to the women, who then included their male partners in the study. The male partners completed their own baseline questionnaire that asked about demographics, medical history, and lifestyle or behavioral factors including marijuana use. The questions centering around marijuana use asked whether the partner had used marijuana within the past 2 months, and the frequency of marijuana use during that period.

Women in PRESTO were followed every 8 weeks until a pregnancy occurred, or up to 12 months if no pregnancy occurred. If they became pregnant, the women were asked additional questions at less than 12 weeks’ gestation and then again at 32 weeks’ gestation, including questions about any miscarriages, and how long a pregnancy lasted if a miscarriage did occur.

At baseline, 1,267 couples (83%) reported no marijuana use by male partners, 140 couples (9%) reported use less than 1 time per week, and 128 couples (8%) reported marijuana use at least 1 time per week. Men at baseline were similar in age and body mass index among groups, but men who used marijuana were more likely to be cigarette smokers (24% vs. 4%), were more likely to have partners who were cigarette smokers (11% vs. 2%), and were more likely to have partners who use marijuana (43% vs. 3%), compared with couples where the male partners did not use marijuana. Male partners who used marijuana also were less likely to be taking a daily multivitamin (25% vs. 37%), and were more likely to have been diagnosed with anxiety (14% vs. 7%) or depression (20% vs. 9%) compared with male partners who did not use marijuana.

Overall, 269 spontaneous abortions (17.5%) occurred during the study period, and couples where male partners used marijuana one or more times per week had approximately twice the rate of spontaneous abortions, compared with no marijuana use (hazard ratio, 1.99; 95% confidence interval).

Couples in which men who used marijuana less than 1 time per week had a slightly increased risk of spontaneous abortion, but this did not reach statistical significance.

When the results were adjusted for female nonusers of marijuana, the results were “essentially identical,” said Ms. Harlow.

Couples who were trying to conceive for three or fewer cycles at baseline (1,045 couples) had a lower rate of spontaneous abortion than that of couples trying for three or more cycles (490 couples). When the results were stratified by gestational age at loss, the results persisted for couples with a pregnancy loss at less than 8 weeks (1,533 couples), but the effect of marijuana use was reduced for couples with a loss at 8 weeks or more (1,113 couples).

Ms. Harlow noted several limitations to the study, including lack of data on time-varying marijuana use, potential selection bias, and residual confounding. There also is likely misclassification of exposure among some participants because marijuana use was self-reported, she added.

Ms. Harlow reported no relevant conflicts of interest.

SOURCE: Harlow AF et al. ASRM 2019. Abstract O-4.

PHILADELPHIA – Women with obesity who underwent a lifestyle program targeting healthy eating and physical activity were significantly more likely to achieve pregnancy or become spontaneously pregnant, Jean-Patrice Baillargeon, MD, MSc, reported at the annual meeting of the American Society for Reproductive Medicine.

World Obesity Federation

However, women with polycystic ovary syndrome (PCOS) in the study appeared to benefit more than did women without PCOS who participated in the lifestyle program, said Dr. Baillargeon, from the University of Sherbrooke (Que.).

“Our lifestyle program targeting women with obesity seeking fertility treatments increased the chances of conceiving, mainly spontaneously. Women with PCOS seemed to benefit more from such a program,” said Dr. Baillargeon.

“These benefits occur along with small changes in weight, but important improvements in lifestyle, so lifestyle seems to be more important than weight change here,” he added.

The researchers randomized 130 women to receive the Fit-For-Fertility lifestyle program or usual care for infertility. The lifestyle program consisted of a low-intensity weekly intervention for 6 weeks in which patients met individually with a kinesiologist and nutritionist every week and also attended group sessions each week. Women in the intervention did not receive fertility treatment for the first 6 months while on the lifestyle program, and if they did not conceive during that time, they continued the program in combination with fertility treatments.

Patients were included if they were aged 18-40 years and had either infertility and a body mass index of 30 kg/m² or greater or PCOS and a BMI of 27 kg/m² or greater. Researchers excluded women planning to undergo bariatric surgery, women who were already undergoing another lifestyle intervention, and women with severe infertility or who had a male partner with severe infertility for whom in vitro fertilization was their only option for conceiving. Researchers collected data from patients at baseline and every 6 months up to 18 months, with additional visits for pregnant women scheduled at the beginning of pregnancy and at 26 weeks’ gestation. They collected baseline data on age, BMI, waist circumference, fat mass percentage, daily energy expenditure, and food frequency using the Healthy Eating Index (HEI).

Overall, 46 women in the intervention group and 52 women in the control group had a research visit at 6 months or pregnancy research visit at less than 6 months; of these, 33 women in the intervention group (65%) and 35 women in the control group (61%) had PCOS. At baseline, both PCOS and non-PCOS groups were similar; however, women in the PCOS intervention group had a lower BMI than did women without PCOS in the intervention group (37 kg/m² vs. 41 kg/m²; P less than .05), while women without PCOS in the intervention group had a higher fat mass percentage than did women with PCOS in the intervention group (46% vs. 49%; P less than .05).

With regard to weight loss, there was a 2.4% reduction in weight among all patients in the intervention group, compared with the control group (P = .003), with a 2.7% reduction in weight for the PCOS group (P = .015) and a 1.8% reduction in the non-PCOS group (P = .139). However, there were no significant differences between PCOS status and the lifestyle intervention, said Dr. Baillargeon.

At 6 months, the quality of women’s diets in the combined PCOS and non-PCOS group that participated in the lifestyle program showed significant improvement, compared with control groups (HEI, 18% vs. 5%; P less than .001). The PCOS group on its own showed significant improvement with the intervention (20% vs. 4%; P less than .001), whereas women without PCOS showed a nonsignificant improvement with the intervention (14% vs. 6%; P = .055). Daily energy expenditure improved in all groups that received the intervention, compared with the control groups, but there were no significant between-group differences in energy expenditure.

When analyzing fertility outcomes at 18 months, the pregnancy rate for all patients who received lifestyle interventions was 61%, compared with 39% in the control group (P = .02; number needed to treat, 4.5). In women with PCOS, those who underwent the lifestyle intervention had a pregnancy rate of 58%, compared with 34% in the control group (P = .05; NNT, 4.3); although women without PCOS who participated in the lifestyle program had an improved pregnancy rate over women in the control group, the results were not significant (67% vs. 46%; P = .18; NNT, 4.7).

The researchers also looked at the spontaneous pregnancy rate and found women who received the intervention had nearly three times the rate of spontaneous pregnancy, compared with women in the control group (33% vs. 12%; P = .01), while women with PCOS in the lifestyle program had nearly five times the rate of spontaneous pregnancy, compared with the control group (27% vs. 6%; P = .02). Women without PCOS in the lifestyle program had nearly twice the increased likelihood of spontaneous pregnancy, but the results were not significant (44% vs. 23%; P = .15).

Women with PCOS in the lifestyle program also had a higher live birth rate, compared with women in the control group (55% vs. 31%; P = .05; NNT, 4.3). Although women without PCOS in the lifestyle program (67% vs. 46%; P = .18; NNT, 4.7) and women in the study overall experienced higher live birth rates (51% vs. 37%; P = .14; NNT, 7.0), compared with the control group, these results were not significant, said Dr. Baillargeon.

“Such lifestyle interventions in women with obesity could significantly lower costs of fertility treatments, which is important,” concluded Dr. Baillargeon.

The Fit-For-Fertility program was funded by an unrestricted grant from Ferring.

SOURCE: Baillargeon J-P, et al. ASRM 2019. Abstract O-95.

PHILADELPHIA – Women with obesity who underwent a lifestyle program targeting healthy eating and physical activity were significantly more likely to achieve pregnancy or become spontaneously pregnant, Jean-Patrice Baillargeon, MD, MSc, reported at the annual meeting of the American Society for Reproductive Medicine.

World Obesity Federation

However, women with polycystic ovary syndrome (PCOS) in the study appeared to benefit more than did women without PCOS who participated in the lifestyle program, said Dr. Baillargeon, from the University of Sherbrooke (Que.).

“Our lifestyle program targeting women with obesity seeking fertility treatments increased the chances of conceiving, mainly spontaneously. Women with PCOS seemed to benefit more from such a program,” said Dr. Baillargeon.

“These benefits occur along with small changes in weight, but important improvements in lifestyle, so lifestyle seems to be more important than weight change here,” he added.

The researchers randomized 130 women to receive the Fit-For-Fertility lifestyle program or usual care for infertility. The lifestyle program consisted of a low-intensity weekly intervention for 6 weeks in which patients met individually with a kinesiologist and nutritionist every week and also attended group sessions each week. Women in the intervention did not receive fertility treatment for the first 6 months while on the lifestyle program, and if they did not conceive during that time, they continued the program in combination with fertility treatments.

Patients were included if they were aged 18-40 years and had either infertility and a body mass index of 30 kg/m² or greater or PCOS and a BMI of 27 kg/m² or greater. Researchers excluded women planning to undergo bariatric surgery, women who were already undergoing another lifestyle intervention, and women with severe infertility or who had a male partner with severe infertility for whom in vitro fertilization was their only option for conceiving. Researchers collected data from patients at baseline and every 6 months up to 18 months, with additional visits for pregnant women scheduled at the beginning of pregnancy and at 26 weeks’ gestation. They collected baseline data on age, BMI, waist circumference, fat mass percentage, daily energy expenditure, and food frequency using the Healthy Eating Index (HEI).

Overall, 46 women in the intervention group and 52 women in the control group had a research visit at 6 months or pregnancy research visit at less than 6 months; of these, 33 women in the intervention group (65%) and 35 women in the control group (61%) had PCOS. At baseline, both PCOS and non-PCOS groups were similar; however, women in the PCOS intervention group had a lower BMI than did women without PCOS in the intervention group (37 kg/m² vs. 41 kg/m²; P less than .05), while women without PCOS in the intervention group had a higher fat mass percentage than did women with PCOS in the intervention group (46% vs. 49%; P less than .05).

With regard to weight loss, there was a 2.4% reduction in weight among all patients in the intervention group, compared with the control group (P = .003), with a 2.7% reduction in weight for the PCOS group (P = .015) and a 1.8% reduction in the non-PCOS group (P = .139). However, there were no significant differences between PCOS status and the lifestyle intervention, said Dr. Baillargeon.

At 6 months, the quality of women’s diets in the combined PCOS and non-PCOS group that participated in the lifestyle program showed significant improvement, compared with control groups (HEI, 18% vs. 5%; P less than .001). The PCOS group on its own showed significant improvement with the intervention (20% vs. 4%; P less than .001), whereas women without PCOS showed a nonsignificant improvement with the intervention (14% vs. 6%; P = .055). Daily energy expenditure improved in all groups that received the intervention, compared with the control groups, but there were no significant between-group differences in energy expenditure.

When analyzing fertility outcomes at 18 months, the pregnancy rate for all patients who received lifestyle interventions was 61%, compared with 39% in the control group (P = .02; number needed to treat, 4.5). In women with PCOS, those who underwent the lifestyle intervention had a pregnancy rate of 58%, compared with 34% in the control group (P = .05; NNT, 4.3); although women without PCOS who participated in the lifestyle program had an improved pregnancy rate over women in the control group, the results were not significant (67% vs. 46%; P = .18; NNT, 4.7).

The researchers also looked at the spontaneous pregnancy rate and found women who received the intervention had nearly three times the rate of spontaneous pregnancy, compared with women in the control group (33% vs. 12%; P = .01), while women with PCOS in the lifestyle program had nearly five times the rate of spontaneous pregnancy, compared with the control group (27% vs. 6%; P = .02). Women without PCOS in the lifestyle program had nearly twice the increased likelihood of spontaneous pregnancy, but the results were not significant (44% vs. 23%; P = .15).

Women with PCOS in the lifestyle program also had a higher live birth rate, compared with women in the control group (55% vs. 31%; P = .05; NNT, 4.3). Although women without PCOS in the lifestyle program (67% vs. 46%; P = .18; NNT, 4.7) and women in the study overall experienced higher live birth rates (51% vs. 37%; P = .14; NNT, 7.0), compared with the control group, these results were not significant, said Dr. Baillargeon.

“Such lifestyle interventions in women with obesity could significantly lower costs of fertility treatments, which is important,” concluded Dr. Baillargeon.

The Fit-For-Fertility program was funded by an unrestricted grant from Ferring.

SOURCE: Baillargeon J-P, et al. ASRM 2019. Abstract O-95.

PHILADELPHIA – Women with obesity who underwent a lifestyle program targeting healthy eating and physical activity were significantly more likely to achieve pregnancy or become spontaneously pregnant, Jean-Patrice Baillargeon, MD, MSc, reported at the annual meeting of the American Society for Reproductive Medicine.

World Obesity Federation

However, women with polycystic ovary syndrome (PCOS) in the study appeared to benefit more than did women without PCOS who participated in the lifestyle program, said Dr. Baillargeon, from the University of Sherbrooke (Que.).

“Our lifestyle program targeting women with obesity seeking fertility treatments increased the chances of conceiving, mainly spontaneously. Women with PCOS seemed to benefit more from such a program,” said Dr. Baillargeon.

“These benefits occur along with small changes in weight, but important improvements in lifestyle, so lifestyle seems to be more important than weight change here,” he added.

The researchers randomized 130 women to receive the Fit-For-Fertility lifestyle program or usual care for infertility. The lifestyle program consisted of a low-intensity weekly intervention for 6 weeks in which patients met individually with a kinesiologist and nutritionist every week and also attended group sessions each week. Women in the intervention did not receive fertility treatment for the first 6 months while on the lifestyle program, and if they did not conceive during that time, they continued the program in combination with fertility treatments.

Patients were included if they were aged 18-40 years and had either infertility and a body mass index of 30 kg/m² or greater or PCOS and a BMI of 27 kg/m² or greater. Researchers excluded women planning to undergo bariatric surgery, women who were already undergoing another lifestyle intervention, and women with severe infertility or who had a male partner with severe infertility for whom in vitro fertilization was their only option for conceiving. Researchers collected data from patients at baseline and every 6 months up to 18 months, with additional visits for pregnant women scheduled at the beginning of pregnancy and at 26 weeks’ gestation. They collected baseline data on age, BMI, waist circumference, fat mass percentage, daily energy expenditure, and food frequency using the Healthy Eating Index (HEI).

Overall, 46 women in the intervention group and 52 women in the control group had a research visit at 6 months or pregnancy research visit at less than 6 months; of these, 33 women in the intervention group (65%) and 35 women in the control group (61%) had PCOS. At baseline, both PCOS and non-PCOS groups were similar; however, women in the PCOS intervention group had a lower BMI than did women without PCOS in the intervention group (37 kg/m² vs. 41 kg/m²; P less than .05), while women without PCOS in the intervention group had a higher fat mass percentage than did women with PCOS in the intervention group (46% vs. 49%; P less than .05).

With regard to weight loss, there was a 2.4% reduction in weight among all patients in the intervention group, compared with the control group (P = .003), with a 2.7% reduction in weight for the PCOS group (P = .015) and a 1.8% reduction in the non-PCOS group (P = .139). However, there were no significant differences between PCOS status and the lifestyle intervention, said Dr. Baillargeon.

At 6 months, the quality of women’s diets in the combined PCOS and non-PCOS group that participated in the lifestyle program showed significant improvement, compared with control groups (HEI, 18% vs. 5%; P less than .001). The PCOS group on its own showed significant improvement with the intervention (20% vs. 4%; P less than .001), whereas women without PCOS showed a nonsignificant improvement with the intervention (14% vs. 6%; P = .055). Daily energy expenditure improved in all groups that received the intervention, compared with the control groups, but there were no significant between-group differences in energy expenditure.

When analyzing fertility outcomes at 18 months, the pregnancy rate for all patients who received lifestyle interventions was 61%, compared with 39% in the control group (P = .02; number needed to treat, 4.5). In women with PCOS, those who underwent the lifestyle intervention had a pregnancy rate of 58%, compared with 34% in the control group (P = .05; NNT, 4.3); although women without PCOS who participated in the lifestyle program had an improved pregnancy rate over women in the control group, the results were not significant (67% vs. 46%; P = .18; NNT, 4.7).

The researchers also looked at the spontaneous pregnancy rate and found women who received the intervention had nearly three times the rate of spontaneous pregnancy, compared with women in the control group (33% vs. 12%; P = .01), while women with PCOS in the lifestyle program had nearly five times the rate of spontaneous pregnancy, compared with the control group (27% vs. 6%; P = .02). Women without PCOS in the lifestyle program had nearly twice the increased likelihood of spontaneous pregnancy, but the results were not significant (44% vs. 23%; P = .15).

Women with PCOS in the lifestyle program also had a higher live birth rate, compared with women in the control group (55% vs. 31%; P = .05; NNT, 4.3). Although women without PCOS in the lifestyle program (67% vs. 46%; P = .18; NNT, 4.7) and women in the study overall experienced higher live birth rates (51% vs. 37%; P = .14; NNT, 7.0), compared with the control group, these results were not significant, said Dr. Baillargeon.

“Such lifestyle interventions in women with obesity could significantly lower costs of fertility treatments, which is important,” concluded Dr. Baillargeon.

The Fit-For-Fertility program was funded by an unrestricted grant from Ferring.

SOURCE: Baillargeon J-P, et al. ASRM 2019. Abstract O-95.

PHILADELPHIA – Women with polycystic ovary syndrome (PCOS) are at a higher risk for metabolic and psychiatric comorbidities prior to pregnancy, cardiometabolic complications during pregnancy, and cardiometabolic and psychiatric complications in the postpartum period, according to results from a prize paper at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Our findings do support the ACOG [American College of Obstetricians and Gynecologists] recommendations that women with PCOS should be considered a high-risk group, and during the postpartum period should be screened for cardiovascular as well as psychiatric comorbidities,” Anuja Dokras, MD, PhD, director of the Penn Polycystic Ovary Syndrome Center at the University of Pennsylvania, Philadelphia, said in her presentation.

Dr. Dokras and colleagues performed a retrospective cohort study during 2000-2016 of patients aged 18-50 years, in the Optum claims database, which comprised 42,391 women with PCOS and 795,480 women without PCOS in 50 U.S. states. Women were included in the analysis if there were data available for at least 6 months to 1 year before pregnancy and between 6 weeks and 1 year after pregnancy. The researchers looked at risk factors prior to pregnancy, such as depression, hypertension, hyperlipidemia, diabetes, obesity, smoking, and use of assisted reproductive technology. During pregnancy, Dr. Dokras and colleagues analyzed complications such as preterm birth, multiple gestation, cesarean section, gestational hypertension and diabetes, preeclampsia and eclampsia, and depression in addition to outcomes in the postpartum period, such as hypertensive complications, thrombotic disease, peripartum cardiomyopathy, heart failure, arterial complications, perinatal and postpartum depression.

“Realizing that PCOS is underreported in administrative data sets, we looked at not only the diagnosis of PCOS but also tried to combine any menstrual irregularity and hirsutism occurring simultaneously, and then doing a sensitivity analysis and looking at the population,” said Dr. Dokras. “Similarly, knowing that misclassification can be an issue in these datasets, we did the same thing amongst the controls, looking for a single diagnosis of irregular menses and hirsutism.”

Prior to pregnancy, women with PCOS in the dataset tended to have a higher rate of obesity (14.7% vs. 4.7%), hyperlipidemia (11.3% vs. 5.3%), hypertension (6.2% vs. 2.5%), diabetes (5.3% vs. 1.2%), and depression (4.3% vs. 3.1%) and were also more likely to use assisted reproductive technology (5.2% vs. 1.0%) than were patients without PCOS (all P less than .001). During pregnancy, there was a higher rate of gestational diabetes (13.7% vs. 7.7%), preeclampsia (5.0% vs. 2.6%), preterm birth (16.9% vs. 12.2%), multiple gestation (6.6% vs. 2.5%), and cesarean section (45.1% vs. 32.9%) in patients with PCOS, compared with those without PCOS (all P less than .001).

For patients in the postpartum period, women with PCOS were more likely to experience postpartum thrombotic disease (adjusted odds ratio, 1.60; 95% confidence interval, 1.23-2.09; P = .001), hypertensive heart disease (aOR, 1.45; 95% CI, 1.04-2.01; P = .027), eclampsia (aOR, 1.45; 95% CI, 1.14-1.86; P = .003), heart failure (aOR, 1.33; 95% CI, 1.08-1.64; P = .007), preeclampsia (aOR, 1.30; 95% CI, 1.17-1.45; P = than .001), and peripartum cardiomyopathy (aOR, 1.26; 95% CI, 1.03-1.54; P = .027).

With regard to depression, women with PCOS also were at greater risk of developing perinatal (aOR, 1.27; 95% CI, 1.22-1.33) and postpartum (aOR, 1.46; 95% CI, 1.36-1.57) depression, compared with women without PCOS (both P less than .001).

Dr. Dokras acknowledged the limitations of administrative datasets and noted that prospective studies need to be conducted to verify their findings.

This study was funded by a grant from the National Institutes of Health. Dr. Dokras reported being a consultant for Medtronic, AbbVie, and Ferring.

SOURCE: Dokras A, et al. ASRM 2019. Abstract O-93.

PHILADELPHIA – Women with polycystic ovary syndrome (PCOS) are at a higher risk for metabolic and psychiatric comorbidities prior to pregnancy, cardiometabolic complications during pregnancy, and cardiometabolic and psychiatric complications in the postpartum period, according to results from a prize paper at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Our findings do support the ACOG [American College of Obstetricians and Gynecologists] recommendations that women with PCOS should be considered a high-risk group, and during the postpartum period should be screened for cardiovascular as well as psychiatric comorbidities,” Anuja Dokras, MD, PhD, director of the Penn Polycystic Ovary Syndrome Center at the University of Pennsylvania, Philadelphia, said in her presentation.

Dr. Dokras and colleagues performed a retrospective cohort study during 2000-2016 of patients aged 18-50 years, in the Optum claims database, which comprised 42,391 women with PCOS and 795,480 women without PCOS in 50 U.S. states. Women were included in the analysis if there were data available for at least 6 months to 1 year before pregnancy and between 6 weeks and 1 year after pregnancy. The researchers looked at risk factors prior to pregnancy, such as depression, hypertension, hyperlipidemia, diabetes, obesity, smoking, and use of assisted reproductive technology. During pregnancy, Dr. Dokras and colleagues analyzed complications such as preterm birth, multiple gestation, cesarean section, gestational hypertension and diabetes, preeclampsia and eclampsia, and depression in addition to outcomes in the postpartum period, such as hypertensive complications, thrombotic disease, peripartum cardiomyopathy, heart failure, arterial complications, perinatal and postpartum depression.

“Realizing that PCOS is underreported in administrative data sets, we looked at not only the diagnosis of PCOS but also tried to combine any menstrual irregularity and hirsutism occurring simultaneously, and then doing a sensitivity analysis and looking at the population,” said Dr. Dokras. “Similarly, knowing that misclassification can be an issue in these datasets, we did the same thing amongst the controls, looking for a single diagnosis of irregular menses and hirsutism.”

Prior to pregnancy, women with PCOS in the dataset tended to have a higher rate of obesity (14.7% vs. 4.7%), hyperlipidemia (11.3% vs. 5.3%), hypertension (6.2% vs. 2.5%), diabetes (5.3% vs. 1.2%), and depression (4.3% vs. 3.1%) and were also more likely to use assisted reproductive technology (5.2% vs. 1.0%) than were patients without PCOS (all P less than .001). During pregnancy, there was a higher rate of gestational diabetes (13.7% vs. 7.7%), preeclampsia (5.0% vs. 2.6%), preterm birth (16.9% vs. 12.2%), multiple gestation (6.6% vs. 2.5%), and cesarean section (45.1% vs. 32.9%) in patients with PCOS, compared with those without PCOS (all P less than .001).

For patients in the postpartum period, women with PCOS were more likely to experience postpartum thrombotic disease (adjusted odds ratio, 1.60; 95% confidence interval, 1.23-2.09; P = .001), hypertensive heart disease (aOR, 1.45; 95% CI, 1.04-2.01; P = .027), eclampsia (aOR, 1.45; 95% CI, 1.14-1.86; P = .003), heart failure (aOR, 1.33; 95% CI, 1.08-1.64; P = .007), preeclampsia (aOR, 1.30; 95% CI, 1.17-1.45; P = than .001), and peripartum cardiomyopathy (aOR, 1.26; 95% CI, 1.03-1.54; P = .027).

With regard to depression, women with PCOS also were at greater risk of developing perinatal (aOR, 1.27; 95% CI, 1.22-1.33) and postpartum (aOR, 1.46; 95% CI, 1.36-1.57) depression, compared with women without PCOS (both P less than .001).

Dr. Dokras acknowledged the limitations of administrative datasets and noted that prospective studies need to be conducted to verify their findings.

This study was funded by a grant from the National Institutes of Health. Dr. Dokras reported being a consultant for Medtronic, AbbVie, and Ferring.

SOURCE: Dokras A, et al. ASRM 2019. Abstract O-93.

PHILADELPHIA – Women with polycystic ovary syndrome (PCOS) are at a higher risk for metabolic and psychiatric comorbidities prior to pregnancy, cardiometabolic complications during pregnancy, and cardiometabolic and psychiatric complications in the postpartum period, according to results from a prize paper at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

“Our findings do support the ACOG [American College of Obstetricians and Gynecologists] recommendations that women with PCOS should be considered a high-risk group, and during the postpartum period should be screened for cardiovascular as well as psychiatric comorbidities,” Anuja Dokras, MD, PhD, director of the Penn Polycystic Ovary Syndrome Center at the University of Pennsylvania, Philadelphia, said in her presentation.

Dr. Dokras and colleagues performed a retrospective cohort study during 2000-2016 of patients aged 18-50 years, in the Optum claims database, which comprised 42,391 women with PCOS and 795,480 women without PCOS in 50 U.S. states. Women were included in the analysis if there were data available for at least 6 months to 1 year before pregnancy and between 6 weeks and 1 year after pregnancy. The researchers looked at risk factors prior to pregnancy, such as depression, hypertension, hyperlipidemia, diabetes, obesity, smoking, and use of assisted reproductive technology. During pregnancy, Dr. Dokras and colleagues analyzed complications such as preterm birth, multiple gestation, cesarean section, gestational hypertension and diabetes, preeclampsia and eclampsia, and depression in addition to outcomes in the postpartum period, such as hypertensive complications, thrombotic disease, peripartum cardiomyopathy, heart failure, arterial complications, perinatal and postpartum depression.

“Realizing that PCOS is underreported in administrative data sets, we looked at not only the diagnosis of PCOS but also tried to combine any menstrual irregularity and hirsutism occurring simultaneously, and then doing a sensitivity analysis and looking at the population,” said Dr. Dokras. “Similarly, knowing that misclassification can be an issue in these datasets, we did the same thing amongst the controls, looking for a single diagnosis of irregular menses and hirsutism.”

Prior to pregnancy, women with PCOS in the dataset tended to have a higher rate of obesity (14.7% vs. 4.7%), hyperlipidemia (11.3% vs. 5.3%), hypertension (6.2% vs. 2.5%), diabetes (5.3% vs. 1.2%), and depression (4.3% vs. 3.1%) and were also more likely to use assisted reproductive technology (5.2% vs. 1.0%) than were patients without PCOS (all P less than .001). During pregnancy, there was a higher rate of gestational diabetes (13.7% vs. 7.7%), preeclampsia (5.0% vs. 2.6%), preterm birth (16.9% vs. 12.2%), multiple gestation (6.6% vs. 2.5%), and cesarean section (45.1% vs. 32.9%) in patients with PCOS, compared with those without PCOS (all P less than .001).

For patients in the postpartum period, women with PCOS were more likely to experience postpartum thrombotic disease (adjusted odds ratio, 1.60; 95% confidence interval, 1.23-2.09; P = .001), hypertensive heart disease (aOR, 1.45; 95% CI, 1.04-2.01; P = .027), eclampsia (aOR, 1.45; 95% CI, 1.14-1.86; P = .003), heart failure (aOR, 1.33; 95% CI, 1.08-1.64; P = .007), preeclampsia (aOR, 1.30; 95% CI, 1.17-1.45; P = than .001), and peripartum cardiomyopathy (aOR, 1.26; 95% CI, 1.03-1.54; P = .027).

With regard to depression, women with PCOS also were at greater risk of developing perinatal (aOR, 1.27; 95% CI, 1.22-1.33) and postpartum (aOR, 1.46; 95% CI, 1.36-1.57) depression, compared with women without PCOS (both P less than .001).

Dr. Dokras acknowledged the limitations of administrative datasets and noted that prospective studies need to be conducted to verify their findings.

This study was funded by a grant from the National Institutes of Health. Dr. Dokras reported being a consultant for Medtronic, AbbVie, and Ferring.

SOURCE: Dokras A, et al. ASRM 2019. Abstract O-93.

PHILADELPHIA – Factors such as primary fibroid volume, fibroid stage, and uterine volume did not appear to affect the efficacy of elagolix in improving heavy menstrual bleeding associated with uterine fibroids, according to results presented at the annual meeting of the American Society for Reproductive Medicine.

Ayman Al-Hendy, MD, PhD, director of translational research at the University of Illinois at Chicago, and associates, analyzed a pooled subgroup of 790 patients from the Elaris UF-1 and UF-2 trials who received elagolix twice daily at a dose of 300 mg (199 patients), elagolix 300 mg twice daily with add-back therapy (1 mg of estradiol plus 0.5 mg of norethindrone acetate; 395 patients), and a placebo group (196 patients) for treatment of heavy menstrual bleeding. Patients were premenopausal women aged 18-51 years with more than 80 mL of menstrual blood loss per cycle. The study design included a washout period, followed by a 2.5-month to 3.5-month screening period, and patients were randomized to 6 months of treatment with placebo, elagolix alone, or elagolix with add-back therapy in a 1:1:2 ratio. Researchers evaluated whether patients had less than 80 mL of menstrual blood loss per cycle and a 50% or more reduction in menstrual blood loss per cycle by the end of the study.

In a subgroup analysis, they also analyzed primary fibroid volume, fibroid stage, and uterine volume. The median primary fibroid volume was 36.2 cm³ (range, 1.0-1,081.5 cm³). Fibroid location was classified using the International Federation of Gynecology and Obstetrics (FIGO) staging system, and researchers placed fibroids into FIGO 0-3, FIGO 4, and FIGO 5-8 groups. At baseline, characteristics between groups were similar, but the patients who received elagolix alone had a lower number of fibroids classified as FIGO 0-3 and had a greater percentage of fibroids less than 36.2 cm³. The median uterine volume was 356.5 cm³ (range, 71.6-3,347.9 cm³).

At final follow-up, 81% of patients receiving elagolix alone and 72% of patients receiving elagolix with add-back therapy responded to treatment, compared with placebo (9%).

Patients receiving elagolix plus add-back therapy responded to treatment better than placebo, and there were no significant differences in outcomes in terms of FIGO stage: Response was as follows for patients with FIGO 0-3 classified fibroids (78% of 47 patients vs. 9% of 25 patients), FIGO 4 fibroids (68% of 177 patients vs. 15% of 85 patients) and FIGO 5-8 fibroids (74% of 165 patients vs. 4% of 82 patients). The same was true in terms of both primary fibroid volume and uterine volume in patients who received elagolix plus add-back therapy, compared with those who received placebo: Patients with a primary fibroid volume of less than 36.2 cm³ (74% of 189 patients vs. 15% of 92 patients) responded similarly to elagolix plus add-back therapy as did patients with a primary fibroid volume greater than 36.2 cm³ (70% of 200 patients vs. 5% of 100 patients), and there were no significant differences between the treatment response of patients with a uterine volume less than 365.5 cm³ (75% of 203 patients vs. 15% of 88 patients) and a uterine volume greater than 365.5 cm³ (70% of 192 patients vs. 5% of 108 patients).

“These really are very encouraging results and suggests that, in women with different fibroids, elagolix with add-back therapy would be an effective treatment option despite uterine and fibroid volume and location of fibroids,” said Dr. Al-Hendy.

Dr. Al-Hendy noted there are ongoing studies analyzing elagolix with add-back in women with fibroids, in women with endometriosis, and elagolix in women with polycystic ovary syndrome.

AbbVie recently submitted a new drug application to the Food and Drug Administration for elagolix based on results from these two trials. Elagolix, an oral GnRh receptor antagonist, is an FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain.

This study was funded by AbbVie, and the company was involved in the study design, research, data collection, analysis and interpretation of the data, as well as the writing, reviewing and approving of the study for publication. The authors reported various relationships with industry, pharmaceutical companies, government entities, and other organizations.
 

SOURCE: Al-Hendy A et al. ASRM 2019, Abstract O-205.

PHILADELPHIA – Factors such as primary fibroid volume, fibroid stage, and uterine volume did not appear to affect the efficacy of elagolix in improving heavy menstrual bleeding associated with uterine fibroids, according to results presented at the annual meeting of the American Society for Reproductive Medicine.

Ayman Al-Hendy, MD, PhD, director of translational research at the University of Illinois at Chicago, and associates, analyzed a pooled subgroup of 790 patients from the Elaris UF-1 and UF-2 trials who received elagolix twice daily at a dose of 300 mg (199 patients), elagolix 300 mg twice daily with add-back therapy (1 mg of estradiol plus 0.5 mg of norethindrone acetate; 395 patients), and a placebo group (196 patients) for treatment of heavy menstrual bleeding. Patients were premenopausal women aged 18-51 years with more than 80 mL of menstrual blood loss per cycle. The study design included a washout period, followed by a 2.5-month to 3.5-month screening period, and patients were randomized to 6 months of treatment with placebo, elagolix alone, or elagolix with add-back therapy in a 1:1:2 ratio. Researchers evaluated whether patients had less than 80 mL of menstrual blood loss per cycle and a 50% or more reduction in menstrual blood loss per cycle by the end of the study.

In a subgroup analysis, they also analyzed primary fibroid volume, fibroid stage, and uterine volume. The median primary fibroid volume was 36.2 cm³ (range, 1.0-1,081.5 cm³). Fibroid location was classified using the International Federation of Gynecology and Obstetrics (FIGO) staging system, and researchers placed fibroids into FIGO 0-3, FIGO 4, and FIGO 5-8 groups. At baseline, characteristics between groups were similar, but the patients who received elagolix alone had a lower number of fibroids classified as FIGO 0-3 and had a greater percentage of fibroids less than 36.2 cm³. The median uterine volume was 356.5 cm³ (range, 71.6-3,347.9 cm³).

At final follow-up, 81% of patients receiving elagolix alone and 72% of patients receiving elagolix with add-back therapy responded to treatment, compared with placebo (9%).

Patients receiving elagolix plus add-back therapy responded to treatment better than placebo, and there were no significant differences in outcomes in terms of FIGO stage: Response was as follows for patients with FIGO 0-3 classified fibroids (78% of 47 patients vs. 9% of 25 patients), FIGO 4 fibroids (68% of 177 patients vs. 15% of 85 patients) and FIGO 5-8 fibroids (74% of 165 patients vs. 4% of 82 patients). The same was true in terms of both primary fibroid volume and uterine volume in patients who received elagolix plus add-back therapy, compared with those who received placebo: Patients with a primary fibroid volume of less than 36.2 cm³ (74% of 189 patients vs. 15% of 92 patients) responded similarly to elagolix plus add-back therapy as did patients with a primary fibroid volume greater than 36.2 cm³ (70% of 200 patients vs. 5% of 100 patients), and there were no significant differences between the treatment response of patients with a uterine volume less than 365.5 cm³ (75% of 203 patients vs. 15% of 88 patients) and a uterine volume greater than 365.5 cm³ (70% of 192 patients vs. 5% of 108 patients).

“These really are very encouraging results and suggests that, in women with different fibroids, elagolix with add-back therapy would be an effective treatment option despite uterine and fibroid volume and location of fibroids,” said Dr. Al-Hendy.

Dr. Al-Hendy noted there are ongoing studies analyzing elagolix with add-back in women with fibroids, in women with endometriosis, and elagolix in women with polycystic ovary syndrome.

AbbVie recently submitted a new drug application to the Food and Drug Administration for elagolix based on results from these two trials. Elagolix, an oral GnRh receptor antagonist, is an FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain.

This study was funded by AbbVie, and the company was involved in the study design, research, data collection, analysis and interpretation of the data, as well as the writing, reviewing and approving of the study for publication. The authors reported various relationships with industry, pharmaceutical companies, government entities, and other organizations.
 

SOURCE: Al-Hendy A et al. ASRM 2019, Abstract O-205.

PHILADELPHIA – Factors such as primary fibroid volume, fibroid stage, and uterine volume did not appear to affect the efficacy of elagolix in improving heavy menstrual bleeding associated with uterine fibroids, according to results presented at the annual meeting of the American Society for Reproductive Medicine.

Ayman Al-Hendy, MD, PhD, director of translational research at the University of Illinois at Chicago, and associates, analyzed a pooled subgroup of 790 patients from the Elaris UF-1 and UF-2 trials who received elagolix twice daily at a dose of 300 mg (199 patients), elagolix 300 mg twice daily with add-back therapy (1 mg of estradiol plus 0.5 mg of norethindrone acetate; 395 patients), and a placebo group (196 patients) for treatment of heavy menstrual bleeding. Patients were premenopausal women aged 18-51 years with more than 80 mL of menstrual blood loss per cycle. The study design included a washout period, followed by a 2.5-month to 3.5-month screening period, and patients were randomized to 6 months of treatment with placebo, elagolix alone, or elagolix with add-back therapy in a 1:1:2 ratio. Researchers evaluated whether patients had less than 80 mL of menstrual blood loss per cycle and a 50% or more reduction in menstrual blood loss per cycle by the end of the study.

In a subgroup analysis, they also analyzed primary fibroid volume, fibroid stage, and uterine volume. The median primary fibroid volume was 36.2 cm³ (range, 1.0-1,081.5 cm³). Fibroid location was classified using the International Federation of Gynecology and Obstetrics (FIGO) staging system, and researchers placed fibroids into FIGO 0-3, FIGO 4, and FIGO 5-8 groups. At baseline, characteristics between groups were similar, but the patients who received elagolix alone had a lower number of fibroids classified as FIGO 0-3 and had a greater percentage of fibroids less than 36.2 cm³. The median uterine volume was 356.5 cm³ (range, 71.6-3,347.9 cm³).

At final follow-up, 81% of patients receiving elagolix alone and 72% of patients receiving elagolix with add-back therapy responded to treatment, compared with placebo (9%).

Patients receiving elagolix plus add-back therapy responded to treatment better than placebo, and there were no significant differences in outcomes in terms of FIGO stage: Response was as follows for patients with FIGO 0-3 classified fibroids (78% of 47 patients vs. 9% of 25 patients), FIGO 4 fibroids (68% of 177 patients vs. 15% of 85 patients) and FIGO 5-8 fibroids (74% of 165 patients vs. 4% of 82 patients). The same was true in terms of both primary fibroid volume and uterine volume in patients who received elagolix plus add-back therapy, compared with those who received placebo: Patients with a primary fibroid volume of less than 36.2 cm³ (74% of 189 patients vs. 15% of 92 patients) responded similarly to elagolix plus add-back therapy as did patients with a primary fibroid volume greater than 36.2 cm³ (70% of 200 patients vs. 5% of 100 patients), and there were no significant differences between the treatment response of patients with a uterine volume less than 365.5 cm³ (75% of 203 patients vs. 15% of 88 patients) and a uterine volume greater than 365.5 cm³ (70% of 192 patients vs. 5% of 108 patients).

“These really are very encouraging results and suggests that, in women with different fibroids, elagolix with add-back therapy would be an effective treatment option despite uterine and fibroid volume and location of fibroids,” said Dr. Al-Hendy.

Dr. Al-Hendy noted there are ongoing studies analyzing elagolix with add-back in women with fibroids, in women with endometriosis, and elagolix in women with polycystic ovary syndrome.

AbbVie recently submitted a new drug application to the Food and Drug Administration for elagolix based on results from these two trials. Elagolix, an oral GnRh receptor antagonist, is an FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain.

This study was funded by AbbVie, and the company was involved in the study design, research, data collection, analysis and interpretation of the data, as well as the writing, reviewing and approving of the study for publication. The authors reported various relationships with industry, pharmaceutical companies, government entities, and other organizations.
 

SOURCE: Al-Hendy A et al. ASRM 2019, Abstract O-205.

PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.

PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.

PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.