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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
VIDEO: Vitrification makes oocyte banking a reality
MUNICH – Quick freezing of oocytes without ice formation–vitrification–has been a "breakthrough" for oocyte banking for both autologous fertility preservation and for oocyte donations, Ana Cobo, Ph.D., said in a video interview during the annual meeting of the European Society of Human Reproduction and Embryology.
Results of studies done by Dr. Cobo and her associates have shown that children born from vitrified oocytes have similar outcomes compared with children born from fresh oocytes. Many women who receive embryos made from donated oocytes are older and may have age-related obstetric complications, but these have no relationship to vitrification itself. Nor are their complications exacerbated by vitrification, said Dr. Cobo, director of the cryopreservation laboratory at the Instituto Valenciano de Infertilidad in Valencia, Spain.
A major advantage of using vitrified oocytes instead of fresh is that cryopreservation makes it much easier to synchronize placement of an appropriately aged embryo with the optimal period of receptivity during the recipient’s cycle, Dr. Cobo said.
Dr. Cobo had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
MUNICH – Quick freezing of oocytes without ice formation–vitrification–has been a "breakthrough" for oocyte banking for both autologous fertility preservation and for oocyte donations, Ana Cobo, Ph.D., said in a video interview during the annual meeting of the European Society of Human Reproduction and Embryology.
Results of studies done by Dr. Cobo and her associates have shown that children born from vitrified oocytes have similar outcomes compared with children born from fresh oocytes. Many women who receive embryos made from donated oocytes are older and may have age-related obstetric complications, but these have no relationship to vitrification itself. Nor are their complications exacerbated by vitrification, said Dr. Cobo, director of the cryopreservation laboratory at the Instituto Valenciano de Infertilidad in Valencia, Spain.
A major advantage of using vitrified oocytes instead of fresh is that cryopreservation makes it much easier to synchronize placement of an appropriately aged embryo with the optimal period of receptivity during the recipient’s cycle, Dr. Cobo said.
Dr. Cobo had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
MUNICH – Quick freezing of oocytes without ice formation–vitrification–has been a "breakthrough" for oocyte banking for both autologous fertility preservation and for oocyte donations, Ana Cobo, Ph.D., said in a video interview during the annual meeting of the European Society of Human Reproduction and Embryology.
Results of studies done by Dr. Cobo and her associates have shown that children born from vitrified oocytes have similar outcomes compared with children born from fresh oocytes. Many women who receive embryos made from donated oocytes are older and may have age-related obstetric complications, but these have no relationship to vitrification itself. Nor are their complications exacerbated by vitrification, said Dr. Cobo, director of the cryopreservation laboratory at the Instituto Valenciano de Infertilidad in Valencia, Spain.
A major advantage of using vitrified oocytes instead of fresh is that cryopreservation makes it much easier to synchronize placement of an appropriately aged embryo with the optimal period of receptivity during the recipient’s cycle, Dr. Cobo said.
Dr. Cobo had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
AT ESHRE 2014
Fertility treatment was associated with limited cancer risks
MUNICH – Hormones and drugs used for fertility treatment of women caused no overall excess of cancers in either the treated women or their children during relatively long follow-up in two large, separate epidemiologic studies.
But results from each of the two studies also showed some evidence of an increased incidence of a few specific types of cancers from two ovarian-stimulating agents, suggesting a need for caution and continued surveillance.
One study, which used a case-control design to analyze data from several Danish national registries, showed that children born to women treated with progesterone had a significantly elevated incidence of leukemias in general, of acute lymphoblastic leukemia specifically, and also of sympathetic nervous system tumors such as neuroblastomas, Marie Hargreave, Ph.D., said at the annual meeting of the European Society of Human Reproduction and Embryology.
"Taking into account the biological plausibility that fertility drugs could cause cancer in children, these results are strong enough to cause concern," said Dr. Hargreave, a researcher at the Danish Cancer Society Research Center.
The second report, a retrospective analysis of cancer cases among nearly 10,000 women who underwent ovulation stimulation at any of five U.S. fertility centers and were followed for 30 years, showed that two very specific subgroups of woman had a significantly increased number of cancers associated with treatment by the ovulation-stimulating drug clomiphene citrate, a selective estrogen-receptor modulator. Nulligravid women treated with clomiphene who then remained nulligravid through follow-up had a significantly increased rate of ovarian cancer, but not breast or endometrial cancer, reported Dr. Humberto Scoccia, professor of ob.gyn. and medical director of the in vitro fertilization program at the University of Illinois in Chicago.
In addition, the small group of 31 women who developed invasive breast cancer during follow-up showed a statistically significant increased rate of this cancer among the women who received clomiphene for 12 or more ovulatory cycles.
However, women in the study received treatment during 1965-1988, an era when clomiphene was used more often and at higher dosages than is typical today, when the maximum number of clomiphene-treatment cycles usually tops out at six, Dr. Scoccia said.
The Danish study used data collected from several national registries on nearly 91,000 children born to mothers who had fertility treatment during 1964-2006. The study focused on 148 of these children who developed cancer as children or young adults, and compared the treatments that their mothers had received with 1,289 cancer-free children born to mothers who had fertility treatment.
The overall findings showed no significantly increased risk for any type of cancer linked with any drug or hormone exposure the mothers received – "quite reassuring results," Dr. Hargreave said.
However, a more granular analysis revealed a few cancers linked to maternal progesterone treatment. Children born to mothers who received progesterone during three or more ovulatory cycles had a statistically significant, fourfold increased rate of all types of leukemias. Cases of acute lymphoblastic leukemia specifically occurred at a significantly increased rate in children whose mothers had received any progesterone exposure, and among children whose mothers received the hormone during three or more cycles, the rate was nearly 10-fold higher than the rate seen in children whose mothers had no progesterone.
In addition, any maternal progesterone exposure also was linked to a significant, nearly sixfold increased rate of sympathetic nervous system tumors in the children. No other drug or hormones used – including clomiphene and various gonadotropins – showed any significant links to offspring cancers.
"This is the largest study reported to date with data on specific fertility drugs, as it had an appropriate reference group," children who remained cancer free but were born to mothers who underwent fertility treatment, Dr. Hargreave noted. She also cautioned that the subanalyses for specific cancer and treatment types involved relatively small numbers of cases.
"Some of the numbers in the subgroup analyses are so small that the findings need to be interpreted with caution," Dr. Scoccia commented during the session. "Multiple prior studies looked at progesterone and did not see a problem," he noted.
"More study of progesterone is needed, as this is the first large epidemiologic study to show this effect," Dr. Hargreave said. "What is important in this study is that we saw no overall increase in cancer rates."
The U.S. study reported by Dr. Scoccia reviewed 9,892 women treated at any of five U.S. fertility clinics during 1965-1988 who also completed a questionnaire in 2000, resulting in follow-up for a median of 30 years from when they received ovulation stimulation. During follow-up, 749 women developed breast cancer, 118 developed endometrial cancer, and 85 developed ovarian cancer.
Among women who received clomiphene, the analysis showed no overall, significantly increased risk of any cancer. But when the analysis broke out the incidence of these three cancer types individually, it showed that the subgroup of women who were nulligravid at treatment and remained nulligravid throughout follow-up had a significant, 3.6-fold increased risk of ovarian cancer, compared with women who did not receive clomiphene. But Dr. Scoccia cautioned that only 13 women were in this subgroup.
A second subgroup analysis that looked specifically at the 31 women who developed invasive breast cancer showed that women who received clomiphene during 12 or more ovulatory cycles had a 69% higher rate of invasive breast cancer than did those who never received clomiphene.
Dr. Scoccia also found that none of the analyses of women who had received a gonadotropin showed any subgroup with an increased rate of cancer.
"Overall, these findings are reassuring," he said, but cautioned that because the women averaged 30 years of age at the time they received fertility treatment, even after 30 years of follow-up these women generally remained younger than the peak age for incidence of these cancer types; hence, further follow-up of the cohort will help further define whether they face increased lifetime cancer rates. He also noted that the higher cancer rates seen with increased clomiphene treatment may link to more resistant infertility among these women rather to than the clomiphene they received, but added "we don’t think it is explained by more resistant infertility alone."
Dr. Hargreave and Dr. Scoccia had no disclosures.
On Twitter @mitchelzoler
MUNICH – Hormones and drugs used for fertility treatment of women caused no overall excess of cancers in either the treated women or their children during relatively long follow-up in two large, separate epidemiologic studies.
But results from each of the two studies also showed some evidence of an increased incidence of a few specific types of cancers from two ovarian-stimulating agents, suggesting a need for caution and continued surveillance.
One study, which used a case-control design to analyze data from several Danish national registries, showed that children born to women treated with progesterone had a significantly elevated incidence of leukemias in general, of acute lymphoblastic leukemia specifically, and also of sympathetic nervous system tumors such as neuroblastomas, Marie Hargreave, Ph.D., said at the annual meeting of the European Society of Human Reproduction and Embryology.
"Taking into account the biological plausibility that fertility drugs could cause cancer in children, these results are strong enough to cause concern," said Dr. Hargreave, a researcher at the Danish Cancer Society Research Center.
The second report, a retrospective analysis of cancer cases among nearly 10,000 women who underwent ovulation stimulation at any of five U.S. fertility centers and were followed for 30 years, showed that two very specific subgroups of woman had a significantly increased number of cancers associated with treatment by the ovulation-stimulating drug clomiphene citrate, a selective estrogen-receptor modulator. Nulligravid women treated with clomiphene who then remained nulligravid through follow-up had a significantly increased rate of ovarian cancer, but not breast or endometrial cancer, reported Dr. Humberto Scoccia, professor of ob.gyn. and medical director of the in vitro fertilization program at the University of Illinois in Chicago.
In addition, the small group of 31 women who developed invasive breast cancer during follow-up showed a statistically significant increased rate of this cancer among the women who received clomiphene for 12 or more ovulatory cycles.
However, women in the study received treatment during 1965-1988, an era when clomiphene was used more often and at higher dosages than is typical today, when the maximum number of clomiphene-treatment cycles usually tops out at six, Dr. Scoccia said.
The Danish study used data collected from several national registries on nearly 91,000 children born to mothers who had fertility treatment during 1964-2006. The study focused on 148 of these children who developed cancer as children or young adults, and compared the treatments that their mothers had received with 1,289 cancer-free children born to mothers who had fertility treatment.
The overall findings showed no significantly increased risk for any type of cancer linked with any drug or hormone exposure the mothers received – "quite reassuring results," Dr. Hargreave said.
However, a more granular analysis revealed a few cancers linked to maternal progesterone treatment. Children born to mothers who received progesterone during three or more ovulatory cycles had a statistically significant, fourfold increased rate of all types of leukemias. Cases of acute lymphoblastic leukemia specifically occurred at a significantly increased rate in children whose mothers had received any progesterone exposure, and among children whose mothers received the hormone during three or more cycles, the rate was nearly 10-fold higher than the rate seen in children whose mothers had no progesterone.
In addition, any maternal progesterone exposure also was linked to a significant, nearly sixfold increased rate of sympathetic nervous system tumors in the children. No other drug or hormones used – including clomiphene and various gonadotropins – showed any significant links to offspring cancers.
"This is the largest study reported to date with data on specific fertility drugs, as it had an appropriate reference group," children who remained cancer free but were born to mothers who underwent fertility treatment, Dr. Hargreave noted. She also cautioned that the subanalyses for specific cancer and treatment types involved relatively small numbers of cases.
"Some of the numbers in the subgroup analyses are so small that the findings need to be interpreted with caution," Dr. Scoccia commented during the session. "Multiple prior studies looked at progesterone and did not see a problem," he noted.
"More study of progesterone is needed, as this is the first large epidemiologic study to show this effect," Dr. Hargreave said. "What is important in this study is that we saw no overall increase in cancer rates."
The U.S. study reported by Dr. Scoccia reviewed 9,892 women treated at any of five U.S. fertility clinics during 1965-1988 who also completed a questionnaire in 2000, resulting in follow-up for a median of 30 years from when they received ovulation stimulation. During follow-up, 749 women developed breast cancer, 118 developed endometrial cancer, and 85 developed ovarian cancer.
Among women who received clomiphene, the analysis showed no overall, significantly increased risk of any cancer. But when the analysis broke out the incidence of these three cancer types individually, it showed that the subgroup of women who were nulligravid at treatment and remained nulligravid throughout follow-up had a significant, 3.6-fold increased risk of ovarian cancer, compared with women who did not receive clomiphene. But Dr. Scoccia cautioned that only 13 women were in this subgroup.
A second subgroup analysis that looked specifically at the 31 women who developed invasive breast cancer showed that women who received clomiphene during 12 or more ovulatory cycles had a 69% higher rate of invasive breast cancer than did those who never received clomiphene.
Dr. Scoccia also found that none of the analyses of women who had received a gonadotropin showed any subgroup with an increased rate of cancer.
"Overall, these findings are reassuring," he said, but cautioned that because the women averaged 30 years of age at the time they received fertility treatment, even after 30 years of follow-up these women generally remained younger than the peak age for incidence of these cancer types; hence, further follow-up of the cohort will help further define whether they face increased lifetime cancer rates. He also noted that the higher cancer rates seen with increased clomiphene treatment may link to more resistant infertility among these women rather to than the clomiphene they received, but added "we don’t think it is explained by more resistant infertility alone."
Dr. Hargreave and Dr. Scoccia had no disclosures.
On Twitter @mitchelzoler
MUNICH – Hormones and drugs used for fertility treatment of women caused no overall excess of cancers in either the treated women or their children during relatively long follow-up in two large, separate epidemiologic studies.
But results from each of the two studies also showed some evidence of an increased incidence of a few specific types of cancers from two ovarian-stimulating agents, suggesting a need for caution and continued surveillance.
One study, which used a case-control design to analyze data from several Danish national registries, showed that children born to women treated with progesterone had a significantly elevated incidence of leukemias in general, of acute lymphoblastic leukemia specifically, and also of sympathetic nervous system tumors such as neuroblastomas, Marie Hargreave, Ph.D., said at the annual meeting of the European Society of Human Reproduction and Embryology.
"Taking into account the biological plausibility that fertility drugs could cause cancer in children, these results are strong enough to cause concern," said Dr. Hargreave, a researcher at the Danish Cancer Society Research Center.
The second report, a retrospective analysis of cancer cases among nearly 10,000 women who underwent ovulation stimulation at any of five U.S. fertility centers and were followed for 30 years, showed that two very specific subgroups of woman had a significantly increased number of cancers associated with treatment by the ovulation-stimulating drug clomiphene citrate, a selective estrogen-receptor modulator. Nulligravid women treated with clomiphene who then remained nulligravid through follow-up had a significantly increased rate of ovarian cancer, but not breast or endometrial cancer, reported Dr. Humberto Scoccia, professor of ob.gyn. and medical director of the in vitro fertilization program at the University of Illinois in Chicago.
In addition, the small group of 31 women who developed invasive breast cancer during follow-up showed a statistically significant increased rate of this cancer among the women who received clomiphene for 12 or more ovulatory cycles.
However, women in the study received treatment during 1965-1988, an era when clomiphene was used more often and at higher dosages than is typical today, when the maximum number of clomiphene-treatment cycles usually tops out at six, Dr. Scoccia said.
The Danish study used data collected from several national registries on nearly 91,000 children born to mothers who had fertility treatment during 1964-2006. The study focused on 148 of these children who developed cancer as children or young adults, and compared the treatments that their mothers had received with 1,289 cancer-free children born to mothers who had fertility treatment.
The overall findings showed no significantly increased risk for any type of cancer linked with any drug or hormone exposure the mothers received – "quite reassuring results," Dr. Hargreave said.
However, a more granular analysis revealed a few cancers linked to maternal progesterone treatment. Children born to mothers who received progesterone during three or more ovulatory cycles had a statistically significant, fourfold increased rate of all types of leukemias. Cases of acute lymphoblastic leukemia specifically occurred at a significantly increased rate in children whose mothers had received any progesterone exposure, and among children whose mothers received the hormone during three or more cycles, the rate was nearly 10-fold higher than the rate seen in children whose mothers had no progesterone.
In addition, any maternal progesterone exposure also was linked to a significant, nearly sixfold increased rate of sympathetic nervous system tumors in the children. No other drug or hormones used – including clomiphene and various gonadotropins – showed any significant links to offspring cancers.
"This is the largest study reported to date with data on specific fertility drugs, as it had an appropriate reference group," children who remained cancer free but were born to mothers who underwent fertility treatment, Dr. Hargreave noted. She also cautioned that the subanalyses for specific cancer and treatment types involved relatively small numbers of cases.
"Some of the numbers in the subgroup analyses are so small that the findings need to be interpreted with caution," Dr. Scoccia commented during the session. "Multiple prior studies looked at progesterone and did not see a problem," he noted.
"More study of progesterone is needed, as this is the first large epidemiologic study to show this effect," Dr. Hargreave said. "What is important in this study is that we saw no overall increase in cancer rates."
The U.S. study reported by Dr. Scoccia reviewed 9,892 women treated at any of five U.S. fertility clinics during 1965-1988 who also completed a questionnaire in 2000, resulting in follow-up for a median of 30 years from when they received ovulation stimulation. During follow-up, 749 women developed breast cancer, 118 developed endometrial cancer, and 85 developed ovarian cancer.
Among women who received clomiphene, the analysis showed no overall, significantly increased risk of any cancer. But when the analysis broke out the incidence of these three cancer types individually, it showed that the subgroup of women who were nulligravid at treatment and remained nulligravid throughout follow-up had a significant, 3.6-fold increased risk of ovarian cancer, compared with women who did not receive clomiphene. But Dr. Scoccia cautioned that only 13 women were in this subgroup.
A second subgroup analysis that looked specifically at the 31 women who developed invasive breast cancer showed that women who received clomiphene during 12 or more ovulatory cycles had a 69% higher rate of invasive breast cancer than did those who never received clomiphene.
Dr. Scoccia also found that none of the analyses of women who had received a gonadotropin showed any subgroup with an increased rate of cancer.
"Overall, these findings are reassuring," he said, but cautioned that because the women averaged 30 years of age at the time they received fertility treatment, even after 30 years of follow-up these women generally remained younger than the peak age for incidence of these cancer types; hence, further follow-up of the cohort will help further define whether they face increased lifetime cancer rates. He also noted that the higher cancer rates seen with increased clomiphene treatment may link to more resistant infertility among these women rather to than the clomiphene they received, but added "we don’t think it is explained by more resistant infertility alone."
Dr. Hargreave and Dr. Scoccia had no disclosures.
On Twitter @mitchelzoler
AT ESHRE 2014
Key clinical point: Results from two large epidemiologic studies suggest fertility treatment posed a limited cancer risk to women and their children.
Major finding: Clomiphene treatment linked with a 3.6-fold increased risk for ovarian cancer, and prolonged use linked with a 69% higher rate of invasive breast cancer. Progesterone treatment was linked with increased leukemias and sympathetic nervous system cancers in the children of treated mothers.
Data source: One study reviewed 9,892 women treated at five U.S. centers during 1965-1988. A second study ran a case-control analysis of 1,437 Danish children born to mothers who underwent fertility treatment.
Disclosures: Dr. Hargreave and Dr. Scoccia had no disclosures.
Children’s Psychiatric Disorders Linked With Moms’ Fertility Problems
MUNICH – Children born to mothers who required fertility treatment had a significantly higher rate of psychiatric disorders, compared with children born to mothers without fertility problems, based on population-wide registry data collected in Denmark.
Although psychiatric disorders occurred a third more often in children born to mothers treated at fertility clinics, this "modest" increase should not deter women with fertility problems from seeking treatment and becoming pregnant, Allan Jensen, Ph.D., said in a video interview at the annual meeting of the European Society of Human Reproduction and Embryology.
The increased risk of psychiatric disorders probably springs from the underlying infertility of these women and damaged genes that they may carry, rather than because of any fertility treatments they received, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center, Copenhagen.
Dr. Jensen said that he had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
MUNICH – Children born to mothers who required fertility treatment had a significantly higher rate of psychiatric disorders, compared with children born to mothers without fertility problems, based on population-wide registry data collected in Denmark.
Although psychiatric disorders occurred a third more often in children born to mothers treated at fertility clinics, this "modest" increase should not deter women with fertility problems from seeking treatment and becoming pregnant, Allan Jensen, Ph.D., said in a video interview at the annual meeting of the European Society of Human Reproduction and Embryology.
The increased risk of psychiatric disorders probably springs from the underlying infertility of these women and damaged genes that they may carry, rather than because of any fertility treatments they received, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center, Copenhagen.
Dr. Jensen said that he had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
MUNICH – Children born to mothers who required fertility treatment had a significantly higher rate of psychiatric disorders, compared with children born to mothers without fertility problems, based on population-wide registry data collected in Denmark.
Although psychiatric disorders occurred a third more often in children born to mothers treated at fertility clinics, this "modest" increase should not deter women with fertility problems from seeking treatment and becoming pregnant, Allan Jensen, Ph.D., said in a video interview at the annual meeting of the European Society of Human Reproduction and Embryology.
The increased risk of psychiatric disorders probably springs from the underlying infertility of these women and damaged genes that they may carry, rather than because of any fertility treatments they received, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center, Copenhagen.
Dr. Jensen said that he had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
AT ESHRE 2014
VIDEO: Children’s psychiatric disorders linked with moms’ fertility problems
MUNICH – Children born to mothers who required fertility treatment had a significantly higher rate of psychiatric disorders, compared with children born to mothers without fertility problems, based on population-wide registry data collected in Denmark.
Although psychiatric disorders occurred a third more often in children born to mothers treated at fertility clinics, this "modest" increase should not deter women with fertility problems from seeking treatment and becoming pregnant, Allan Jensen, Ph.D., said in a video interview at the annual meeting of the European Society of Human Reproduction and Embryology.
The increased risk of psychiatric disorders probably springs from the underlying infertility of these women and damaged genes that they may carry, rather than because of any fertility treatments they received, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center, Copenhagen.
Dr. Jensen said that he had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
MUNICH – Children born to mothers who required fertility treatment had a significantly higher rate of psychiatric disorders, compared with children born to mothers without fertility problems, based on population-wide registry data collected in Denmark.
Although psychiatric disorders occurred a third more often in children born to mothers treated at fertility clinics, this "modest" increase should not deter women with fertility problems from seeking treatment and becoming pregnant, Allan Jensen, Ph.D., said in a video interview at the annual meeting of the European Society of Human Reproduction and Embryology.
The increased risk of psychiatric disorders probably springs from the underlying infertility of these women and damaged genes that they may carry, rather than because of any fertility treatments they received, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center, Copenhagen.
Dr. Jensen said that he had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
MUNICH – Children born to mothers who required fertility treatment had a significantly higher rate of psychiatric disorders, compared with children born to mothers without fertility problems, based on population-wide registry data collected in Denmark.
Although psychiatric disorders occurred a third more often in children born to mothers treated at fertility clinics, this "modest" increase should not deter women with fertility problems from seeking treatment and becoming pregnant, Allan Jensen, Ph.D., said in a video interview at the annual meeting of the European Society of Human Reproduction and Embryology.
The increased risk of psychiatric disorders probably springs from the underlying infertility of these women and damaged genes that they may carry, rather than because of any fertility treatments they received, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center, Copenhagen.
Dr. Jensen said that he had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
AT ESHRE 2014
Transcatheter mitral valve replacement reboots
PARIS – Transcatheter mitral valve replacement finally took off this year, but it may keep a low profile short-term as investigators gain more clinical experience with transcatheter systems and slowly start to define the right types of patients for this procedure.
Transcatheter mitral valve replacement (TMVR) had something of a false start 2 years ago when CardiAQ announced the first clinical case of a patient with severe mitral valve regurgitation who underwent valve replacement using a transcatheter system at the Heart Centre of Rigshospitalet University Hospital, Copenhagen. Further details of that first case have not yet been reported. It was not until this past May that a second patient underwent TMVR performed by the same Danish team, using a second-generation CardiAQ system.
Also this year came reports on two new TMVR systems, each used for the first time clinically, with five patients treated with the Fortis system made by Edwards Lifesciences, and two treated with the Tiara system made by Neovasc.
"We are finally on the journey of assessment of multiple transcatheter mitral valves. We’ve been saying that for a number of years, but it seems like now we truly will see progress in the mitral space," Dr. Martyn Thomas said during a talk at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
At the meeting, Dr. Thomas, an interventional cardiologist at St. Thomas’ Hospital, London, and his associate Vinayak Bapat, a cardiac surgeon, reported the experience with five patients treated with the Fortis valve system, including three patients treated by them and their colleagues in London, one patient in Bern, Switzerland, and a fifth who had been treated in Toronto just 4 days before their report at the meeting.
"We have shown that we can deploy the valve, that the valve functions; and we have one patient who is gradually improving, so I believe that the principle is now there as long as we can find the patients" best suited to TMVR, Dr. Thomas said.
"Patient selection is everything," he noted. The selection process is "perhaps more difficult than for transcatheter aortic valve replacement." Patients with severe mitral valve regurgitation often have substantial comorbidities such as left ventricular dysfunction, pulmonary disease, and renal disease, and these may mean a much longer delay to see patient improvement following TMVR compared with after an aortic valve is replaced, he noted.
"Valve replacement seeks to eliminate mitral regurgitation, while clip systems attempt to reduce regurgitation by about one grade. We need to do both, and the difficulty will be determining which patients should get what treatment," Dr. Thomas said in an interview. "Perhaps the highest-risk patients should undergo repair" with a clip, he suggested.
"We need to select patients who will survive the [TMVR] procedure and get through the following 3 months because we may not see any benefit for 3-6 months, in contrast to aortic valve patients who recover and improve very quickly. I believe we will develop a complex algorithm based on each patient’s anatomy that will address the procedure’s risk and its potential to eliminate mitral regurgitation. The mitral clip is a relatively safe procedure, so it will be a much more complex algorithm than for the aortic valve."
A second report at the meeting reviewed experience with the first two patients who received the Tiara TMVR system, both at St. Paul’s Hospital in Vancouver, B.C. Like the Fortis valve, the Tiara is delivered by a transapical approach. The Tiara system delivers a mitral valve via a 32F catheter; the size of the Fortis catheter has not been reported, but a spokeswoman for Edwards acknowledged that it was a similarly large catheter and that efforts are ongoing to try to cut the catheter size. The Fortis mitral valve is 29 mm in diameter, while the size of the Tiara valve has not been reported. Procedure times for the two Tiara cases were 20 minutes for the first patient and 12 minutes for the second, reported Dr. Anson W. Cheung, surgical director of cardiac transplantation at St. Paul’s. The Fortis valve cases showed a learning curve similar to that of the Tiara cases, with the Fortis procedure time falling from 93 minutes for the first patient to 34 minutes for the fourth.
"The key is to catch patients before their left ventricle burns out, and to prevent the vicious cycle of high afterloading" that can occur when the mitral valve is replaced, Dr. Cheung said. He reported that his two cases had no complications or left ventricular outflow tract obstruction, and that one patient has now survived more than 3 months and has shown improved heart function and a halving of her baseline blood level of brain natriuretic peptide.
"In patients with aortic stenosis, when you remove the obstructed [aortic] valve, they improve. In patients with mitral regurgitation, who develop very severely depressed left ventricular function, once you correct the regurgitation it increases stress on the ventricle and they can get into trouble," commented Dr. William Wijns, codirector of the Cardiovascular Center in Aalst, Belgium. "The complexity of the mitral valve problem is several orders of magnitude greater than with transcatheter aortic valve replacement," Dr. Wijns said.
Dr. Thomas has been a consultant to and has received research support from Edwards, the company developing the Fortis valve. Mr. Bapat has been a consultant to Edwards, Medtronic, and St. Jude and has received research support from Edwards. Dr. Cheung has been a consultant to and received honoraria from Neovasc, the company developing the Tiara valve. Dr. Wijns has received grant support to his institution from Edwards and 15 other companies, and he owns stock in two health care companies and a biotechnology company.
On Twitter @mitchelzoler
We had a phase of several years when the mitral valve programs were working hard to figure out how to get started. There has been a sort of critical mass of learning that has now launched the field, with reports on clinical use of three different systems coming out this year.
The procedural understanding that developed during a decade of work on transcatheter aortic valve replacement has helped us figure out how to do mitral valves by generating a broad base of technique development, for example, an understanding of how to percutaneously deliver prosthetic devices more coaxially. It sounds simple, but it had been a critical obstacle for treating the mitral valve.
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Other technical challenges of transcatheter mitral valve replacement have been designing replacement valves to fit the noncircular mitral orifice, and the absence of calcium deposits on the mitral valve to help anchor a prosthesis. There has also been improving understanding of patient selection, including which patients are best suited to transcatheter mitral valve replacement and when is the best time in the course of mitral valve disease to intervene.
Although the safety and efficacy of the mitral clip as a transcatheter approach to mitral valve repair are now established, at least half and perhaps as many as three-quarters of patients with severe mitral regurgitation are not good candidates for clip repair. This includes patients with commissural mitral regurgitation because clip placement in corners can be difficult, patients with large jet origins that can be too big to grab with a clip, and patients with calcified mitral valve leaflets that can’t be clipped, so there are plenty of patients for whom transcatheter valve replacement would be better than clipping.
D. Ted Feldman, M.D., is director of cardiac catheterization at North Shore University Health System in Evanston, Ill. He was lead investigator for the EVEREST II trial that established the safety and efficacy of the mitral clip (N. Engl. J. Med 2011;364:1395-1406). He has been a consultant to Abbott Vascular, Boston Scientific, Edwards, and Jenavalve. He made these comments in an interview.
We had a phase of several years when the mitral valve programs were working hard to figure out how to get started. There has been a sort of critical mass of learning that has now launched the field, with reports on clinical use of three different systems coming out this year.
The procedural understanding that developed during a decade of work on transcatheter aortic valve replacement has helped us figure out how to do mitral valves by generating a broad base of technique development, for example, an understanding of how to percutaneously deliver prosthetic devices more coaxially. It sounds simple, but it had been a critical obstacle for treating the mitral valve.
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Other technical challenges of transcatheter mitral valve replacement have been designing replacement valves to fit the noncircular mitral orifice, and the absence of calcium deposits on the mitral valve to help anchor a prosthesis. There has also been improving understanding of patient selection, including which patients are best suited to transcatheter mitral valve replacement and when is the best time in the course of mitral valve disease to intervene.
Although the safety and efficacy of the mitral clip as a transcatheter approach to mitral valve repair are now established, at least half and perhaps as many as three-quarters of patients with severe mitral regurgitation are not good candidates for clip repair. This includes patients with commissural mitral regurgitation because clip placement in corners can be difficult, patients with large jet origins that can be too big to grab with a clip, and patients with calcified mitral valve leaflets that can’t be clipped, so there are plenty of patients for whom transcatheter valve replacement would be better than clipping.
D. Ted Feldman, M.D., is director of cardiac catheterization at North Shore University Health System in Evanston, Ill. He was lead investigator for the EVEREST II trial that established the safety and efficacy of the mitral clip (N. Engl. J. Med 2011;364:1395-1406). He has been a consultant to Abbott Vascular, Boston Scientific, Edwards, and Jenavalve. He made these comments in an interview.
We had a phase of several years when the mitral valve programs were working hard to figure out how to get started. There has been a sort of critical mass of learning that has now launched the field, with reports on clinical use of three different systems coming out this year.
The procedural understanding that developed during a decade of work on transcatheter aortic valve replacement has helped us figure out how to do mitral valves by generating a broad base of technique development, for example, an understanding of how to percutaneously deliver prosthetic devices more coaxially. It sounds simple, but it had been a critical obstacle for treating the mitral valve.
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Other technical challenges of transcatheter mitral valve replacement have been designing replacement valves to fit the noncircular mitral orifice, and the absence of calcium deposits on the mitral valve to help anchor a prosthesis. There has also been improving understanding of patient selection, including which patients are best suited to transcatheter mitral valve replacement and when is the best time in the course of mitral valve disease to intervene.
Although the safety and efficacy of the mitral clip as a transcatheter approach to mitral valve repair are now established, at least half and perhaps as many as three-quarters of patients with severe mitral regurgitation are not good candidates for clip repair. This includes patients with commissural mitral regurgitation because clip placement in corners can be difficult, patients with large jet origins that can be too big to grab with a clip, and patients with calcified mitral valve leaflets that can’t be clipped, so there are plenty of patients for whom transcatheter valve replacement would be better than clipping.
D. Ted Feldman, M.D., is director of cardiac catheterization at North Shore University Health System in Evanston, Ill. He was lead investigator for the EVEREST II trial that established the safety and efficacy of the mitral clip (N. Engl. J. Med 2011;364:1395-1406). He has been a consultant to Abbott Vascular, Boston Scientific, Edwards, and Jenavalve. He made these comments in an interview.
PARIS – Transcatheter mitral valve replacement finally took off this year, but it may keep a low profile short-term as investigators gain more clinical experience with transcatheter systems and slowly start to define the right types of patients for this procedure.
Transcatheter mitral valve replacement (TMVR) had something of a false start 2 years ago when CardiAQ announced the first clinical case of a patient with severe mitral valve regurgitation who underwent valve replacement using a transcatheter system at the Heart Centre of Rigshospitalet University Hospital, Copenhagen. Further details of that first case have not yet been reported. It was not until this past May that a second patient underwent TMVR performed by the same Danish team, using a second-generation CardiAQ system.
Also this year came reports on two new TMVR systems, each used for the first time clinically, with five patients treated with the Fortis system made by Edwards Lifesciences, and two treated with the Tiara system made by Neovasc.
"We are finally on the journey of assessment of multiple transcatheter mitral valves. We’ve been saying that for a number of years, but it seems like now we truly will see progress in the mitral space," Dr. Martyn Thomas said during a talk at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
At the meeting, Dr. Thomas, an interventional cardiologist at St. Thomas’ Hospital, London, and his associate Vinayak Bapat, a cardiac surgeon, reported the experience with five patients treated with the Fortis valve system, including three patients treated by them and their colleagues in London, one patient in Bern, Switzerland, and a fifth who had been treated in Toronto just 4 days before their report at the meeting.
"We have shown that we can deploy the valve, that the valve functions; and we have one patient who is gradually improving, so I believe that the principle is now there as long as we can find the patients" best suited to TMVR, Dr. Thomas said.
"Patient selection is everything," he noted. The selection process is "perhaps more difficult than for transcatheter aortic valve replacement." Patients with severe mitral valve regurgitation often have substantial comorbidities such as left ventricular dysfunction, pulmonary disease, and renal disease, and these may mean a much longer delay to see patient improvement following TMVR compared with after an aortic valve is replaced, he noted.
"Valve replacement seeks to eliminate mitral regurgitation, while clip systems attempt to reduce regurgitation by about one grade. We need to do both, and the difficulty will be determining which patients should get what treatment," Dr. Thomas said in an interview. "Perhaps the highest-risk patients should undergo repair" with a clip, he suggested.
"We need to select patients who will survive the [TMVR] procedure and get through the following 3 months because we may not see any benefit for 3-6 months, in contrast to aortic valve patients who recover and improve very quickly. I believe we will develop a complex algorithm based on each patient’s anatomy that will address the procedure’s risk and its potential to eliminate mitral regurgitation. The mitral clip is a relatively safe procedure, so it will be a much more complex algorithm than for the aortic valve."
A second report at the meeting reviewed experience with the first two patients who received the Tiara TMVR system, both at St. Paul’s Hospital in Vancouver, B.C. Like the Fortis valve, the Tiara is delivered by a transapical approach. The Tiara system delivers a mitral valve via a 32F catheter; the size of the Fortis catheter has not been reported, but a spokeswoman for Edwards acknowledged that it was a similarly large catheter and that efforts are ongoing to try to cut the catheter size. The Fortis mitral valve is 29 mm in diameter, while the size of the Tiara valve has not been reported. Procedure times for the two Tiara cases were 20 minutes for the first patient and 12 minutes for the second, reported Dr. Anson W. Cheung, surgical director of cardiac transplantation at St. Paul’s. The Fortis valve cases showed a learning curve similar to that of the Tiara cases, with the Fortis procedure time falling from 93 minutes for the first patient to 34 minutes for the fourth.
"The key is to catch patients before their left ventricle burns out, and to prevent the vicious cycle of high afterloading" that can occur when the mitral valve is replaced, Dr. Cheung said. He reported that his two cases had no complications or left ventricular outflow tract obstruction, and that one patient has now survived more than 3 months and has shown improved heart function and a halving of her baseline blood level of brain natriuretic peptide.
"In patients with aortic stenosis, when you remove the obstructed [aortic] valve, they improve. In patients with mitral regurgitation, who develop very severely depressed left ventricular function, once you correct the regurgitation it increases stress on the ventricle and they can get into trouble," commented Dr. William Wijns, codirector of the Cardiovascular Center in Aalst, Belgium. "The complexity of the mitral valve problem is several orders of magnitude greater than with transcatheter aortic valve replacement," Dr. Wijns said.
Dr. Thomas has been a consultant to and has received research support from Edwards, the company developing the Fortis valve. Mr. Bapat has been a consultant to Edwards, Medtronic, and St. Jude and has received research support from Edwards. Dr. Cheung has been a consultant to and received honoraria from Neovasc, the company developing the Tiara valve. Dr. Wijns has received grant support to his institution from Edwards and 15 other companies, and he owns stock in two health care companies and a biotechnology company.
On Twitter @mitchelzoler
PARIS – Transcatheter mitral valve replacement finally took off this year, but it may keep a low profile short-term as investigators gain more clinical experience with transcatheter systems and slowly start to define the right types of patients for this procedure.
Transcatheter mitral valve replacement (TMVR) had something of a false start 2 years ago when CardiAQ announced the first clinical case of a patient with severe mitral valve regurgitation who underwent valve replacement using a transcatheter system at the Heart Centre of Rigshospitalet University Hospital, Copenhagen. Further details of that first case have not yet been reported. It was not until this past May that a second patient underwent TMVR performed by the same Danish team, using a second-generation CardiAQ system.
Also this year came reports on two new TMVR systems, each used for the first time clinically, with five patients treated with the Fortis system made by Edwards Lifesciences, and two treated with the Tiara system made by Neovasc.
"We are finally on the journey of assessment of multiple transcatheter mitral valves. We’ve been saying that for a number of years, but it seems like now we truly will see progress in the mitral space," Dr. Martyn Thomas said during a talk at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
At the meeting, Dr. Thomas, an interventional cardiologist at St. Thomas’ Hospital, London, and his associate Vinayak Bapat, a cardiac surgeon, reported the experience with five patients treated with the Fortis valve system, including three patients treated by them and their colleagues in London, one patient in Bern, Switzerland, and a fifth who had been treated in Toronto just 4 days before their report at the meeting.
"We have shown that we can deploy the valve, that the valve functions; and we have one patient who is gradually improving, so I believe that the principle is now there as long as we can find the patients" best suited to TMVR, Dr. Thomas said.
"Patient selection is everything," he noted. The selection process is "perhaps more difficult than for transcatheter aortic valve replacement." Patients with severe mitral valve regurgitation often have substantial comorbidities such as left ventricular dysfunction, pulmonary disease, and renal disease, and these may mean a much longer delay to see patient improvement following TMVR compared with after an aortic valve is replaced, he noted.
"Valve replacement seeks to eliminate mitral regurgitation, while clip systems attempt to reduce regurgitation by about one grade. We need to do both, and the difficulty will be determining which patients should get what treatment," Dr. Thomas said in an interview. "Perhaps the highest-risk patients should undergo repair" with a clip, he suggested.
"We need to select patients who will survive the [TMVR] procedure and get through the following 3 months because we may not see any benefit for 3-6 months, in contrast to aortic valve patients who recover and improve very quickly. I believe we will develop a complex algorithm based on each patient’s anatomy that will address the procedure’s risk and its potential to eliminate mitral regurgitation. The mitral clip is a relatively safe procedure, so it will be a much more complex algorithm than for the aortic valve."
A second report at the meeting reviewed experience with the first two patients who received the Tiara TMVR system, both at St. Paul’s Hospital in Vancouver, B.C. Like the Fortis valve, the Tiara is delivered by a transapical approach. The Tiara system delivers a mitral valve via a 32F catheter; the size of the Fortis catheter has not been reported, but a spokeswoman for Edwards acknowledged that it was a similarly large catheter and that efforts are ongoing to try to cut the catheter size. The Fortis mitral valve is 29 mm in diameter, while the size of the Tiara valve has not been reported. Procedure times for the two Tiara cases were 20 minutes for the first patient and 12 minutes for the second, reported Dr. Anson W. Cheung, surgical director of cardiac transplantation at St. Paul’s. The Fortis valve cases showed a learning curve similar to that of the Tiara cases, with the Fortis procedure time falling from 93 minutes for the first patient to 34 minutes for the fourth.
"The key is to catch patients before their left ventricle burns out, and to prevent the vicious cycle of high afterloading" that can occur when the mitral valve is replaced, Dr. Cheung said. He reported that his two cases had no complications or left ventricular outflow tract obstruction, and that one patient has now survived more than 3 months and has shown improved heart function and a halving of her baseline blood level of brain natriuretic peptide.
"In patients with aortic stenosis, when you remove the obstructed [aortic] valve, they improve. In patients with mitral regurgitation, who develop very severely depressed left ventricular function, once you correct the regurgitation it increases stress on the ventricle and they can get into trouble," commented Dr. William Wijns, codirector of the Cardiovascular Center in Aalst, Belgium. "The complexity of the mitral valve problem is several orders of magnitude greater than with transcatheter aortic valve replacement," Dr. Wijns said.
Dr. Thomas has been a consultant to and has received research support from Edwards, the company developing the Fortis valve. Mr. Bapat has been a consultant to Edwards, Medtronic, and St. Jude and has received research support from Edwards. Dr. Cheung has been a consultant to and received honoraria from Neovasc, the company developing the Tiara valve. Dr. Wijns has received grant support to his institution from Edwards and 15 other companies, and he owns stock in two health care companies and a biotechnology company.
On Twitter @mitchelzoler
AT EUROPCR 2014
Children’s psychiatric disorders linked with moms’ infertility
MUNICH – Children born to mothers who had fertility problems had a 33% increased incidence of psychiatric disorders as children or young adults, compared with the offspring from mothers without fertility problems, a population-based Danish study found.
While clinicians and patients should be aware of this "modest" increased risk, it should be "balanced against the physical and psychological benefits of pregnancy," Allan Jensen, Ph.D., said at the annual meeting of the European Society of Human Reproduction and Embryology.
"I think this is an acceptable risk" from the perspective of both individual women and society, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center in Copenhagen. The findings "should not discourage women from receiving fertility treatment," he said in an interview. "I think this is a small risk."
Dr. Jensen estimated that about 2% of psychiatric disorders that exist today among Danish children and adults are attributable to mothers who underwent fertility treatment. Although his study has not yet analyzed whether any specific treatments used during assisted reproduction seemed to link with subsequent psychiatric disorders in offspring, he speculated that the primary mechanism is likely defective genes carried by women with fertility problems.
The Danish infertility cohort contained information on more than 109,000 women who underwent a fertility consultation from 1963 to 2009, and these data were used along with Danish birth records starting from 1969 and Danish national medical records for psychiatric disorders that also dated from 1969. The analysis identified 7,860 children or adults who had received a psychiatric diagnosis and were born to women treated for fertility problems.
Results from a multivariate, regression analysis that controlled for year of birth, maternal age at birth, sex, and birth order, showed that children of mothers who had received fertility treatment had a statistically significant, 33% increased rate of having a psychiatric disorder, compared with people born to mothers without a fertility problem.
Additional analysis showed statistically significant increases across a broad swath of psychiatric disorders. For example, children born to mothers who had fertility treatment had a 47% higher rate of attention-deficit/hyperactivity disorder, a 43% higher rate of personality and behavior disorders, a 32% increase in affective disorders, a 28% higher rate of mental retardation, a 27% higher rate of schizophrenia, and a 12% higher rate of autism-spectrum disorders.
The analysis did not adjust for fertility treatment the women received or for child factors such as birth weight and prematurity. But the analysis did find that a statistically increased rate of various psychiatric disorders existed independently in both children and in young adults.
The study had the advantages of using the largest population ever examined for this issue, including a long follow-up, and avoiding selection bias or recall bias by being population- and registry-based, with virtually complete ascertainment of psychiatric cases. It had the shortcoming of being unable to distinguish cause from infertility in the women or from the treatments they received, Dr. Jensen said.
Dr. Jensen said that he had no disclosures.
On Twitter @mitchelzoler
MUNICH – Children born to mothers who had fertility problems had a 33% increased incidence of psychiatric disorders as children or young adults, compared with the offspring from mothers without fertility problems, a population-based Danish study found.
While clinicians and patients should be aware of this "modest" increased risk, it should be "balanced against the physical and psychological benefits of pregnancy," Allan Jensen, Ph.D., said at the annual meeting of the European Society of Human Reproduction and Embryology.
"I think this is an acceptable risk" from the perspective of both individual women and society, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center in Copenhagen. The findings "should not discourage women from receiving fertility treatment," he said in an interview. "I think this is a small risk."
Dr. Jensen estimated that about 2% of psychiatric disorders that exist today among Danish children and adults are attributable to mothers who underwent fertility treatment. Although his study has not yet analyzed whether any specific treatments used during assisted reproduction seemed to link with subsequent psychiatric disorders in offspring, he speculated that the primary mechanism is likely defective genes carried by women with fertility problems.
The Danish infertility cohort contained information on more than 109,000 women who underwent a fertility consultation from 1963 to 2009, and these data were used along with Danish birth records starting from 1969 and Danish national medical records for psychiatric disorders that also dated from 1969. The analysis identified 7,860 children or adults who had received a psychiatric diagnosis and were born to women treated for fertility problems.
Results from a multivariate, regression analysis that controlled for year of birth, maternal age at birth, sex, and birth order, showed that children of mothers who had received fertility treatment had a statistically significant, 33% increased rate of having a psychiatric disorder, compared with people born to mothers without a fertility problem.
Additional analysis showed statistically significant increases across a broad swath of psychiatric disorders. For example, children born to mothers who had fertility treatment had a 47% higher rate of attention-deficit/hyperactivity disorder, a 43% higher rate of personality and behavior disorders, a 32% increase in affective disorders, a 28% higher rate of mental retardation, a 27% higher rate of schizophrenia, and a 12% higher rate of autism-spectrum disorders.
The analysis did not adjust for fertility treatment the women received or for child factors such as birth weight and prematurity. But the analysis did find that a statistically increased rate of various psychiatric disorders existed independently in both children and in young adults.
The study had the advantages of using the largest population ever examined for this issue, including a long follow-up, and avoiding selection bias or recall bias by being population- and registry-based, with virtually complete ascertainment of psychiatric cases. It had the shortcoming of being unable to distinguish cause from infertility in the women or from the treatments they received, Dr. Jensen said.
Dr. Jensen said that he had no disclosures.
On Twitter @mitchelzoler
MUNICH – Children born to mothers who had fertility problems had a 33% increased incidence of psychiatric disorders as children or young adults, compared with the offspring from mothers without fertility problems, a population-based Danish study found.
While clinicians and patients should be aware of this "modest" increased risk, it should be "balanced against the physical and psychological benefits of pregnancy," Allan Jensen, Ph.D., said at the annual meeting of the European Society of Human Reproduction and Embryology.
"I think this is an acceptable risk" from the perspective of both individual women and society, said Dr. Jensen, a senior researcher at the Danish Cancer Society Research Center in Copenhagen. The findings "should not discourage women from receiving fertility treatment," he said in an interview. "I think this is a small risk."
Dr. Jensen estimated that about 2% of psychiatric disorders that exist today among Danish children and adults are attributable to mothers who underwent fertility treatment. Although his study has not yet analyzed whether any specific treatments used during assisted reproduction seemed to link with subsequent psychiatric disorders in offspring, he speculated that the primary mechanism is likely defective genes carried by women with fertility problems.
The Danish infertility cohort contained information on more than 109,000 women who underwent a fertility consultation from 1963 to 2009, and these data were used along with Danish birth records starting from 1969 and Danish national medical records for psychiatric disorders that also dated from 1969. The analysis identified 7,860 children or adults who had received a psychiatric diagnosis and were born to women treated for fertility problems.
Results from a multivariate, regression analysis that controlled for year of birth, maternal age at birth, sex, and birth order, showed that children of mothers who had received fertility treatment had a statistically significant, 33% increased rate of having a psychiatric disorder, compared with people born to mothers without a fertility problem.
Additional analysis showed statistically significant increases across a broad swath of psychiatric disorders. For example, children born to mothers who had fertility treatment had a 47% higher rate of attention-deficit/hyperactivity disorder, a 43% higher rate of personality and behavior disorders, a 32% increase in affective disorders, a 28% higher rate of mental retardation, a 27% higher rate of schizophrenia, and a 12% higher rate of autism-spectrum disorders.
The analysis did not adjust for fertility treatment the women received or for child factors such as birth weight and prematurity. But the analysis did find that a statistically increased rate of various psychiatric disorders existed independently in both children and in young adults.
The study had the advantages of using the largest population ever examined for this issue, including a long follow-up, and avoiding selection bias or recall bias by being population- and registry-based, with virtually complete ascertainment of psychiatric cases. It had the shortcoming of being unable to distinguish cause from infertility in the women or from the treatments they received, Dr. Jensen said.
Dr. Jensen said that he had no disclosures.
On Twitter @mitchelzoler
AT ESHRE 2014
Key clinical point: Women with fertility problems who became pregnant through assisted technology had a significantly increased rate of children with psychiatric disorders.
Major finding: Women with fertility problems had a 33% increased rate of having children with a psychiatric disorder.
Data source: Danish national medical registry data for the 2.4 million children born in Denmark during 1969-2006 and for 109,000 women who had fertility treatment during the period.
Disclosures: Dr. Jensen said that he had no disclosures.
Efficacy, safety seen with transcatheter pulmonary valve
WASHINGTON - A transcatheter pulmonary valve system that provides a new right ventricle to pulmonary artery conduit to congenital heart disease patients without the need for open heart surgery performed a little better in a real-world registry at 10 U.S. centers than it had in the pivotal trial that led to the system's 2010 FDA approval.
The new results "confirm the strong performance of the Melody transcatheter pulmonary valve achieved by real-world providers with results comparable to the U.S. investigational device exemption [IDE] trial," Dr. Aimee K. Armstrong said at the annual meeting of the American College of Cardiology. The "high level" of 97% freedom from transcatheter pulmonary valve (TPV) dysfunction at 1 year "was better than in the IDE trial," where the level reached 94%, noted Dr. Armstrong of the University of Michigan in Ann Arbor.
The registry study, which the FDA mandated when it approved the Melody valve in 2010, ran during July 2010 to July 2012 at 10 U.S. centers that had not participated in the pivotal trial. The 99 patients who received an implant that stayed in place for at least 1 day ranged from 5 to 45 years old, with an average age of 20 years. Although patient follow-up averaged 22 months, the study's primary endpoint was acceptable hemodynamic function within the conduit at 6 months, with a prespecified performance goal of 75% of patients achieving this outcome. The outcome actually occurred in 97% of the 90 evaluable patients at 6 months, and in 88% of all 99 patients who received a conduit. The difference between each of these rates and the performance goal was statistically significant, Dr. Armstrong said.
The transcatheter valve showed excellent performance by other criteria as well. Acceptable hemodynamic function continued through 1 year in 94% of the 87 implanted patients with evaluable data at 12 months, which translated to 83% of the entire 99 patients in the implanted group. Severe or moderate pulmonary valve regurgitation existed in 85% of the patients before treatment; after treatment no patient had severe or moderate regurgitation, and after 1 year 63% had no regurgitation, 24% had trace, and 12% had mild regurgitation (figures total 99% because of rounding). The 1-year rate of 97% of patients free from dysfunction of their implanted valve appeared to surpass the 94% rate seen in the pivotal trial (Circulation 2010;122:507-16).
The results also showed that high right ventricular pressure prior to valve placement was the only variable independently associated with subsequent valve dysfunction. "Patients who go into the procedure with a very stenotic conduit are probably at higher risk for transcatheter pulmonary valve dysfunction down the road," she said.
The study was sponsored by Medtronic, which markets the Melody transcatheter pulmonary valve. Dr. Armstrong said she has received research funding from Medtronic and Edwards Lifesciences.
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| Dr. Robert Jaquiss |
This study is an important post-approval demonstration that the excellent early results obtained in the original IDE trial in the United States can be reproduced or even exceeded with a broader rollout of the Melody valve to many more centers. The next set of data, which is eagerly anticipated, is the mid-term and longer results for the Melody valve, which will begin to answer questions about the durability of valve competence. Additional information about the performance of the valve in alternative anatomic settings, such as in failing stented bioprostheses - so-called "valve-in-valve" usage - is also beginning to accumulate.
Dr. Robert Jaquiss is professor of surgery and pediatrics and chief of pediatric heart surgery at Duke University School of Medicine and an associate medical editor for Vascular Specialist.
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| Dr. Robert Jaquiss |
This study is an important post-approval demonstration that the excellent early results obtained in the original IDE trial in the United States can be reproduced or even exceeded with a broader rollout of the Melody valve to many more centers. The next set of data, which is eagerly anticipated, is the mid-term and longer results for the Melody valve, which will begin to answer questions about the durability of valve competence. Additional information about the performance of the valve in alternative anatomic settings, such as in failing stented bioprostheses - so-called "valve-in-valve" usage - is also beginning to accumulate.
Dr. Robert Jaquiss is professor of surgery and pediatrics and chief of pediatric heart surgery at Duke University School of Medicine and an associate medical editor for Vascular Specialist.
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| Dr. Robert Jaquiss |
This study is an important post-approval demonstration that the excellent early results obtained in the original IDE trial in the United States can be reproduced or even exceeded with a broader rollout of the Melody valve to many more centers. The next set of data, which is eagerly anticipated, is the mid-term and longer results for the Melody valve, which will begin to answer questions about the durability of valve competence. Additional information about the performance of the valve in alternative anatomic settings, such as in failing stented bioprostheses - so-called "valve-in-valve" usage - is also beginning to accumulate.
Dr. Robert Jaquiss is professor of surgery and pediatrics and chief of pediatric heart surgery at Duke University School of Medicine and an associate medical editor for Vascular Specialist.
WASHINGTON - A transcatheter pulmonary valve system that provides a new right ventricle to pulmonary artery conduit to congenital heart disease patients without the need for open heart surgery performed a little better in a real-world registry at 10 U.S. centers than it had in the pivotal trial that led to the system's 2010 FDA approval.
The new results "confirm the strong performance of the Melody transcatheter pulmonary valve achieved by real-world providers with results comparable to the U.S. investigational device exemption [IDE] trial," Dr. Aimee K. Armstrong said at the annual meeting of the American College of Cardiology. The "high level" of 97% freedom from transcatheter pulmonary valve (TPV) dysfunction at 1 year "was better than in the IDE trial," where the level reached 94%, noted Dr. Armstrong of the University of Michigan in Ann Arbor.
The registry study, which the FDA mandated when it approved the Melody valve in 2010, ran during July 2010 to July 2012 at 10 U.S. centers that had not participated in the pivotal trial. The 99 patients who received an implant that stayed in place for at least 1 day ranged from 5 to 45 years old, with an average age of 20 years. Although patient follow-up averaged 22 months, the study's primary endpoint was acceptable hemodynamic function within the conduit at 6 months, with a prespecified performance goal of 75% of patients achieving this outcome. The outcome actually occurred in 97% of the 90 evaluable patients at 6 months, and in 88% of all 99 patients who received a conduit. The difference between each of these rates and the performance goal was statistically significant, Dr. Armstrong said.
The transcatheter valve showed excellent performance by other criteria as well. Acceptable hemodynamic function continued through 1 year in 94% of the 87 implanted patients with evaluable data at 12 months, which translated to 83% of the entire 99 patients in the implanted group. Severe or moderate pulmonary valve regurgitation existed in 85% of the patients before treatment; after treatment no patient had severe or moderate regurgitation, and after 1 year 63% had no regurgitation, 24% had trace, and 12% had mild regurgitation (figures total 99% because of rounding). The 1-year rate of 97% of patients free from dysfunction of their implanted valve appeared to surpass the 94% rate seen in the pivotal trial (Circulation 2010;122:507-16).
The results also showed that high right ventricular pressure prior to valve placement was the only variable independently associated with subsequent valve dysfunction. "Patients who go into the procedure with a very stenotic conduit are probably at higher risk for transcatheter pulmonary valve dysfunction down the road," she said.
The study was sponsored by Medtronic, which markets the Melody transcatheter pulmonary valve. Dr. Armstrong said she has received research funding from Medtronic and Edwards Lifesciences.
WASHINGTON - A transcatheter pulmonary valve system that provides a new right ventricle to pulmonary artery conduit to congenital heart disease patients without the need for open heart surgery performed a little better in a real-world registry at 10 U.S. centers than it had in the pivotal trial that led to the system's 2010 FDA approval.
The new results "confirm the strong performance of the Melody transcatheter pulmonary valve achieved by real-world providers with results comparable to the U.S. investigational device exemption [IDE] trial," Dr. Aimee K. Armstrong said at the annual meeting of the American College of Cardiology. The "high level" of 97% freedom from transcatheter pulmonary valve (TPV) dysfunction at 1 year "was better than in the IDE trial," where the level reached 94%, noted Dr. Armstrong of the University of Michigan in Ann Arbor.
The registry study, which the FDA mandated when it approved the Melody valve in 2010, ran during July 2010 to July 2012 at 10 U.S. centers that had not participated in the pivotal trial. The 99 patients who received an implant that stayed in place for at least 1 day ranged from 5 to 45 years old, with an average age of 20 years. Although patient follow-up averaged 22 months, the study's primary endpoint was acceptable hemodynamic function within the conduit at 6 months, with a prespecified performance goal of 75% of patients achieving this outcome. The outcome actually occurred in 97% of the 90 evaluable patients at 6 months, and in 88% of all 99 patients who received a conduit. The difference between each of these rates and the performance goal was statistically significant, Dr. Armstrong said.
The transcatheter valve showed excellent performance by other criteria as well. Acceptable hemodynamic function continued through 1 year in 94% of the 87 implanted patients with evaluable data at 12 months, which translated to 83% of the entire 99 patients in the implanted group. Severe or moderate pulmonary valve regurgitation existed in 85% of the patients before treatment; after treatment no patient had severe or moderate regurgitation, and after 1 year 63% had no regurgitation, 24% had trace, and 12% had mild regurgitation (figures total 99% because of rounding). The 1-year rate of 97% of patients free from dysfunction of their implanted valve appeared to surpass the 94% rate seen in the pivotal trial (Circulation 2010;122:507-16).
The results also showed that high right ventricular pressure prior to valve placement was the only variable independently associated with subsequent valve dysfunction. "Patients who go into the procedure with a very stenotic conduit are probably at higher risk for transcatheter pulmonary valve dysfunction down the road," she said.
The study was sponsored by Medtronic, which markets the Melody transcatheter pulmonary valve. Dr. Armstrong said she has received research funding from Medtronic and Edwards Lifesciences.
Key clinical point: The Melody transcatheter pulmonary valve system worked as well in a real world registry as it did in its pivotal trial as a conduit between the right ventricle and pulmonary artery.
Major finding: Acceptable hemodynamic function at 6 months occurred in 88% of implanted patients, significantly surpassing the 75% performance goal.
Data source: A series of 99 patients who received a transcatheter pulmonary valve at any of 10 participating U.S. centers.
Disclosures: The study was sponsored by Medtronic, which markets the Melody transcatheter pulmonary valve. Dr. Armstrong said that she has received consultant fees and honoraria from Siemens Healthcare and St. Jude Medical, and has received research funding from Medtronic and Edwards Lifesciences.
Donated IVF eggs linked to gestational hypertension
MUNICH – Women pregnant with an embryo produced by in vitro fertilization of a donated egg developed gestational hypertension at nearly four times the rate of matched women who were pregnant following IVF with a self egg, in a multicenter, case-control study with 580 participants.
In addition, preeclampsia was more than four times higher in the women who had received a donor egg as part of an IVF procedure, compared with women who used a self egg for their IVF, Dr. Hélène Letur-Könirsch reported at the annual meeting of the European Society of Human Reproduction and Embryology.
Although the mechanism underlying this association is not known, one possible explanation is that when a woman carries an embryo that is completely allogenic, it triggers modified immune tolerance that leads to impaired trophoblast implantation. Other candidate hypotheses are that defective genes in the mother trigger abnormal metabolic pathways that cause hypertension and preeclampsia, and that ovarian insufficiency features reduced ovarian steroid production, causing vascular and immunologic changes that lead to pregnancy-induced hypertension.
Results from several prior studies also had shown a link between use of a donor egg for IVF and an increased rate of gestational hypertension and preeclampsia, but most prior studies had been smaller and failed to adequately control for possible confounders, said Dr. Letur-Könirsch, an endocrinologist at the Fertility Center of the Institut Mutualiste Montsouris in Paris.
She and her associates from seven IVF centers in France pooled data from their entire series of IVF cases that involved donated eggs during the period from February 2005 to September 2012, a total of 217 pregnant women. The analysis matched these cases with 363 control women who had IVF pregnancies during the study period using self eggs by parameters such as age, parity, time of pregnancy, and whether the IVF procedure involved transfer of a fresh or frozen embryo.
Women in the study averaged 35 years of age, with 82% aged 39 years or younger. Average body mass index was virtually identical in both groups, about 24 kg/m2, and the live-birth rate was 79% in both groups. All women in both groups were normotensive prior to their IVF procedure.
The incidence of pregnancy-induced hypertension, defined as blood pressure that reached at least 140/90 mm Hg when measured in office on both arms with two separate measurements, was about 29% in the women who received a donated egg and 14% in those who used a self egg. Development of preeclampsia, defined as persistent gestational hypertension plus proteinuria of at least 0.3 g/day, occurred in about 18% of women who received a donated egg and 7% in those who used a self egg.
In a multivariate analysis that controlled for age, pregnancy history, and use of a fresh or frozen embryo, women who used a donated egg had a 3.9-fold increased rate of pregnancy-induced hypertension and a 4.6-fold increased rate of preeclampsia, compared with women who used a self egg – both statistically significant differences.
The findings suggested that before a woman embarks on pregnancy using a donated egg, she should undergo thorough evaluation for preexisting risk factors for gestational hypertension, including hypertension, obesity, diabetes, renal disease, chronic infection, autoimmune diseases such as systemic lupus erythematosus, a family history of preeclampsia, and living at a high altitude. If these risk factors are present, they should be controlled if possible. Women who have one or more of these risk factors may also be candidates for prophylactic treatment with aspirin to prevent development of preeclampsia, especially if they develop pregnancy-induced hypertension.
During pregnancy, women who received a donor egg should undergo regular and frequent blood pressure measurement, as well as assessment for other possible abnormalities such as Doppler ultrasound examination of uterine arteries and measuring serum and urine markers.
"Physicians and patients must be aware of the risk [from donor eggs] to assure that these women get adequate monitoring and management during pregnancy," Dr. Letur-Könirsch said.
Dr. Letur-Könirsch had no disclosures.
On Twitter @mitchelzoler
MUNICH – Women pregnant with an embryo produced by in vitro fertilization of a donated egg developed gestational hypertension at nearly four times the rate of matched women who were pregnant following IVF with a self egg, in a multicenter, case-control study with 580 participants.
In addition, preeclampsia was more than four times higher in the women who had received a donor egg as part of an IVF procedure, compared with women who used a self egg for their IVF, Dr. Hélène Letur-Könirsch reported at the annual meeting of the European Society of Human Reproduction and Embryology.
Although the mechanism underlying this association is not known, one possible explanation is that when a woman carries an embryo that is completely allogenic, it triggers modified immune tolerance that leads to impaired trophoblast implantation. Other candidate hypotheses are that defective genes in the mother trigger abnormal metabolic pathways that cause hypertension and preeclampsia, and that ovarian insufficiency features reduced ovarian steroid production, causing vascular and immunologic changes that lead to pregnancy-induced hypertension.
Results from several prior studies also had shown a link between use of a donor egg for IVF and an increased rate of gestational hypertension and preeclampsia, but most prior studies had been smaller and failed to adequately control for possible confounders, said Dr. Letur-Könirsch, an endocrinologist at the Fertility Center of the Institut Mutualiste Montsouris in Paris.
She and her associates from seven IVF centers in France pooled data from their entire series of IVF cases that involved donated eggs during the period from February 2005 to September 2012, a total of 217 pregnant women. The analysis matched these cases with 363 control women who had IVF pregnancies during the study period using self eggs by parameters such as age, parity, time of pregnancy, and whether the IVF procedure involved transfer of a fresh or frozen embryo.
Women in the study averaged 35 years of age, with 82% aged 39 years or younger. Average body mass index was virtually identical in both groups, about 24 kg/m2, and the live-birth rate was 79% in both groups. All women in both groups were normotensive prior to their IVF procedure.
The incidence of pregnancy-induced hypertension, defined as blood pressure that reached at least 140/90 mm Hg when measured in office on both arms with two separate measurements, was about 29% in the women who received a donated egg and 14% in those who used a self egg. Development of preeclampsia, defined as persistent gestational hypertension plus proteinuria of at least 0.3 g/day, occurred in about 18% of women who received a donated egg and 7% in those who used a self egg.
In a multivariate analysis that controlled for age, pregnancy history, and use of a fresh or frozen embryo, women who used a donated egg had a 3.9-fold increased rate of pregnancy-induced hypertension and a 4.6-fold increased rate of preeclampsia, compared with women who used a self egg – both statistically significant differences.
The findings suggested that before a woman embarks on pregnancy using a donated egg, she should undergo thorough evaluation for preexisting risk factors for gestational hypertension, including hypertension, obesity, diabetes, renal disease, chronic infection, autoimmune diseases such as systemic lupus erythematosus, a family history of preeclampsia, and living at a high altitude. If these risk factors are present, they should be controlled if possible. Women who have one or more of these risk factors may also be candidates for prophylactic treatment with aspirin to prevent development of preeclampsia, especially if they develop pregnancy-induced hypertension.
During pregnancy, women who received a donor egg should undergo regular and frequent blood pressure measurement, as well as assessment for other possible abnormalities such as Doppler ultrasound examination of uterine arteries and measuring serum and urine markers.
"Physicians and patients must be aware of the risk [from donor eggs] to assure that these women get adequate monitoring and management during pregnancy," Dr. Letur-Könirsch said.
Dr. Letur-Könirsch had no disclosures.
On Twitter @mitchelzoler
MUNICH – Women pregnant with an embryo produced by in vitro fertilization of a donated egg developed gestational hypertension at nearly four times the rate of matched women who were pregnant following IVF with a self egg, in a multicenter, case-control study with 580 participants.
In addition, preeclampsia was more than four times higher in the women who had received a donor egg as part of an IVF procedure, compared with women who used a self egg for their IVF, Dr. Hélène Letur-Könirsch reported at the annual meeting of the European Society of Human Reproduction and Embryology.
Although the mechanism underlying this association is not known, one possible explanation is that when a woman carries an embryo that is completely allogenic, it triggers modified immune tolerance that leads to impaired trophoblast implantation. Other candidate hypotheses are that defective genes in the mother trigger abnormal metabolic pathways that cause hypertension and preeclampsia, and that ovarian insufficiency features reduced ovarian steroid production, causing vascular and immunologic changes that lead to pregnancy-induced hypertension.
Results from several prior studies also had shown a link between use of a donor egg for IVF and an increased rate of gestational hypertension and preeclampsia, but most prior studies had been smaller and failed to adequately control for possible confounders, said Dr. Letur-Könirsch, an endocrinologist at the Fertility Center of the Institut Mutualiste Montsouris in Paris.
She and her associates from seven IVF centers in France pooled data from their entire series of IVF cases that involved donated eggs during the period from February 2005 to September 2012, a total of 217 pregnant women. The analysis matched these cases with 363 control women who had IVF pregnancies during the study period using self eggs by parameters such as age, parity, time of pregnancy, and whether the IVF procedure involved transfer of a fresh or frozen embryo.
Women in the study averaged 35 years of age, with 82% aged 39 years or younger. Average body mass index was virtually identical in both groups, about 24 kg/m2, and the live-birth rate was 79% in both groups. All women in both groups were normotensive prior to their IVF procedure.
The incidence of pregnancy-induced hypertension, defined as blood pressure that reached at least 140/90 mm Hg when measured in office on both arms with two separate measurements, was about 29% in the women who received a donated egg and 14% in those who used a self egg. Development of preeclampsia, defined as persistent gestational hypertension plus proteinuria of at least 0.3 g/day, occurred in about 18% of women who received a donated egg and 7% in those who used a self egg.
In a multivariate analysis that controlled for age, pregnancy history, and use of a fresh or frozen embryo, women who used a donated egg had a 3.9-fold increased rate of pregnancy-induced hypertension and a 4.6-fold increased rate of preeclampsia, compared with women who used a self egg – both statistically significant differences.
The findings suggested that before a woman embarks on pregnancy using a donated egg, she should undergo thorough evaluation for preexisting risk factors for gestational hypertension, including hypertension, obesity, diabetes, renal disease, chronic infection, autoimmune diseases such as systemic lupus erythematosus, a family history of preeclampsia, and living at a high altitude. If these risk factors are present, they should be controlled if possible. Women who have one or more of these risk factors may also be candidates for prophylactic treatment with aspirin to prevent development of preeclampsia, especially if they develop pregnancy-induced hypertension.
During pregnancy, women who received a donor egg should undergo regular and frequent blood pressure measurement, as well as assessment for other possible abnormalities such as Doppler ultrasound examination of uterine arteries and measuring serum and urine markers.
"Physicians and patients must be aware of the risk [from donor eggs] to assure that these women get adequate monitoring and management during pregnancy," Dr. Letur-Könirsch said.
Dr. Letur-Könirsch had no disclosures.
On Twitter @mitchelzoler
AT ESHRE 2014
Key clinical point: Women who became pregnant by in vitro fertilization with a donated egg had a substantially increased risk of pregnancy-induced hypertension and preeclampsia.
Major finding: Women with IVF pregnancy using donated eggs had a 3.9-fold increased rate of gestational hypertension, compared with women using self eggs.
Data source: A case-control study with 580 women who underwent IVF at any of seven French fertility clinics.
Disclosures: Dr. Letur-Könirsch had no disclosures.
Routine hysteroscopy failed to aid recurrent miscarriages
MUNICH – Routine hysteroscopy and treatment of uterine abnormalities found by using it failed to improve the live-birth rate after in vitro fertilization in asymptomatic women with no ultrasound findings who already had failed two to four attempts at pregnancy and delivery with IVF, in a randomized, controlled trial of 656 women.
"Out-patient hysteroscopy cannot be routinely recommended after recurrent in vitro fertilization failure," concluded Dr. Tarek El-Toukhy at the annual meeting of the European Society of Human Reproduction and Embryology.
Based on these findings, hysteroscopy should be limited to women with clinical symptoms or ultrasound findings that suggest an abnormality in the uterine cavity, but hysteroscopy should not be performed routinely in all women who have a history of multiple miscarriages, said Dr. El-Toukhy, a gynecologist at Guy’s and St. Thomas’ Hospital in London.
The study results indicated that roughly one in nine of the enrolled women had a uterine abnormality that was detectable by hysteroscopy, but finding and correcting these problems had no effect on pregnancy outcomes.
Seeing these data, "I have the impression that [routine hysteroscopy] is of no use. The study was well done," commented Dr. Klaus Friese, a gynecologist and director of the Women’s Hospital of the University of Munich.
"When you see something unusual by ultrasound or if you suspect a problem, then you should do hysteroscopy, but not just because the women had three miscarriages when the ultrasound shows nothing," Dr. Friese said in an interview.
The findings also suggest that when multiple miscarriages occur following IVF, embryo factors are often involved rather than issues in the mother, said Dr. El-Toukhy. "Even when women had a uterine issue, treatment did not help. That lends more importance to embryo factors. Uterine factors can be important, but not as important as embryo factors" to explain multiple miscarriages following IVF, he said.
The TROPHY (Trial of Outpatient Hysteroscopy) study was run at eight centers in four European countries. The investigators randomized women who were younger than 38 years and who had a body mass index of less than 35 kg/m2, a history of two to four prior miscarriages following IVF, and a normal-appearing uterus when assessed by transvaginal ultrasonography. Woman randomized to routine hysteroscopy had the procedure done using a Campo Trophyscope marketed by Karl Storz. Uterine abnormalities found by routine hysteroscopy were treated when appropriate. All women enrolled then underwent ovarian stimulation and IVF using usual local protocols.
At the end of the study, the 332 women randomized to routine hysteroscopy with evaluable follow-up had a 39% pregnancy rate and a 30% live-birth rate, not statistically different from the 39% pregnancy rate and 29% live-birth rate seen among 324 evaluable women randomized to no hysteroscopy, Dr. El-Toukhy reported.
In the women randomized to routine hysteroscopy, 11% showed a significant abnormality on examination, including 15 women with an arcuate uterus, 11 women with endometrial polyps, and five women with a partial septum, as well as women with a few other less common abnormalities. Fifteen women underwent a surgical procedure to address abnormalities found by hysteroscopy. Hysteroscopy also found one or more "subtle" abnormalities in 13% of the examined women, a category for abnormalities of uncertain significance that included hypervascularization of the uterus (20 women) and mucosal elevation (13 women). None of the subtle abnormalities received treatment.
Prespecified analyses of the outcomes in the subgroup of women who had routine hysteroscopy showed no statistically significant differences in the pregnancy or live-birth rates of the women with or without significant uterine abnormalities identified by hysteroscopy or in the women with or without subtle uterine abnormalities, Dr. El-Toukhy said.
Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures. Dr. Friese had no relevant disclosures.
On Twitter @mitchelzoler
MUNICH – Routine hysteroscopy and treatment of uterine abnormalities found by using it failed to improve the live-birth rate after in vitro fertilization in asymptomatic women with no ultrasound findings who already had failed two to four attempts at pregnancy and delivery with IVF, in a randomized, controlled trial of 656 women.
"Out-patient hysteroscopy cannot be routinely recommended after recurrent in vitro fertilization failure," concluded Dr. Tarek El-Toukhy at the annual meeting of the European Society of Human Reproduction and Embryology.
Based on these findings, hysteroscopy should be limited to women with clinical symptoms or ultrasound findings that suggest an abnormality in the uterine cavity, but hysteroscopy should not be performed routinely in all women who have a history of multiple miscarriages, said Dr. El-Toukhy, a gynecologist at Guy’s and St. Thomas’ Hospital in London.
The study results indicated that roughly one in nine of the enrolled women had a uterine abnormality that was detectable by hysteroscopy, but finding and correcting these problems had no effect on pregnancy outcomes.
Seeing these data, "I have the impression that [routine hysteroscopy] is of no use. The study was well done," commented Dr. Klaus Friese, a gynecologist and director of the Women’s Hospital of the University of Munich.
"When you see something unusual by ultrasound or if you suspect a problem, then you should do hysteroscopy, but not just because the women had three miscarriages when the ultrasound shows nothing," Dr. Friese said in an interview.
The findings also suggest that when multiple miscarriages occur following IVF, embryo factors are often involved rather than issues in the mother, said Dr. El-Toukhy. "Even when women had a uterine issue, treatment did not help. That lends more importance to embryo factors. Uterine factors can be important, but not as important as embryo factors" to explain multiple miscarriages following IVF, he said.
The TROPHY (Trial of Outpatient Hysteroscopy) study was run at eight centers in four European countries. The investigators randomized women who were younger than 38 years and who had a body mass index of less than 35 kg/m2, a history of two to four prior miscarriages following IVF, and a normal-appearing uterus when assessed by transvaginal ultrasonography. Woman randomized to routine hysteroscopy had the procedure done using a Campo Trophyscope marketed by Karl Storz. Uterine abnormalities found by routine hysteroscopy were treated when appropriate. All women enrolled then underwent ovarian stimulation and IVF using usual local protocols.
At the end of the study, the 332 women randomized to routine hysteroscopy with evaluable follow-up had a 39% pregnancy rate and a 30% live-birth rate, not statistically different from the 39% pregnancy rate and 29% live-birth rate seen among 324 evaluable women randomized to no hysteroscopy, Dr. El-Toukhy reported.
In the women randomized to routine hysteroscopy, 11% showed a significant abnormality on examination, including 15 women with an arcuate uterus, 11 women with endometrial polyps, and five women with a partial septum, as well as women with a few other less common abnormalities. Fifteen women underwent a surgical procedure to address abnormalities found by hysteroscopy. Hysteroscopy also found one or more "subtle" abnormalities in 13% of the examined women, a category for abnormalities of uncertain significance that included hypervascularization of the uterus (20 women) and mucosal elevation (13 women). None of the subtle abnormalities received treatment.
Prespecified analyses of the outcomes in the subgroup of women who had routine hysteroscopy showed no statistically significant differences in the pregnancy or live-birth rates of the women with or without significant uterine abnormalities identified by hysteroscopy or in the women with or without subtle uterine abnormalities, Dr. El-Toukhy said.
Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures. Dr. Friese had no relevant disclosures.
On Twitter @mitchelzoler
MUNICH – Routine hysteroscopy and treatment of uterine abnormalities found by using it failed to improve the live-birth rate after in vitro fertilization in asymptomatic women with no ultrasound findings who already had failed two to four attempts at pregnancy and delivery with IVF, in a randomized, controlled trial of 656 women.
"Out-patient hysteroscopy cannot be routinely recommended after recurrent in vitro fertilization failure," concluded Dr. Tarek El-Toukhy at the annual meeting of the European Society of Human Reproduction and Embryology.
Based on these findings, hysteroscopy should be limited to women with clinical symptoms or ultrasound findings that suggest an abnormality in the uterine cavity, but hysteroscopy should not be performed routinely in all women who have a history of multiple miscarriages, said Dr. El-Toukhy, a gynecologist at Guy’s and St. Thomas’ Hospital in London.
The study results indicated that roughly one in nine of the enrolled women had a uterine abnormality that was detectable by hysteroscopy, but finding and correcting these problems had no effect on pregnancy outcomes.
Seeing these data, "I have the impression that [routine hysteroscopy] is of no use. The study was well done," commented Dr. Klaus Friese, a gynecologist and director of the Women’s Hospital of the University of Munich.
"When you see something unusual by ultrasound or if you suspect a problem, then you should do hysteroscopy, but not just because the women had three miscarriages when the ultrasound shows nothing," Dr. Friese said in an interview.
The findings also suggest that when multiple miscarriages occur following IVF, embryo factors are often involved rather than issues in the mother, said Dr. El-Toukhy. "Even when women had a uterine issue, treatment did not help. That lends more importance to embryo factors. Uterine factors can be important, but not as important as embryo factors" to explain multiple miscarriages following IVF, he said.
The TROPHY (Trial of Outpatient Hysteroscopy) study was run at eight centers in four European countries. The investigators randomized women who were younger than 38 years and who had a body mass index of less than 35 kg/m2, a history of two to four prior miscarriages following IVF, and a normal-appearing uterus when assessed by transvaginal ultrasonography. Woman randomized to routine hysteroscopy had the procedure done using a Campo Trophyscope marketed by Karl Storz. Uterine abnormalities found by routine hysteroscopy were treated when appropriate. All women enrolled then underwent ovarian stimulation and IVF using usual local protocols.
At the end of the study, the 332 women randomized to routine hysteroscopy with evaluable follow-up had a 39% pregnancy rate and a 30% live-birth rate, not statistically different from the 39% pregnancy rate and 29% live-birth rate seen among 324 evaluable women randomized to no hysteroscopy, Dr. El-Toukhy reported.
In the women randomized to routine hysteroscopy, 11% showed a significant abnormality on examination, including 15 women with an arcuate uterus, 11 women with endometrial polyps, and five women with a partial septum, as well as women with a few other less common abnormalities. Fifteen women underwent a surgical procedure to address abnormalities found by hysteroscopy. Hysteroscopy also found one or more "subtle" abnormalities in 13% of the examined women, a category for abnormalities of uncertain significance that included hypervascularization of the uterus (20 women) and mucosal elevation (13 women). None of the subtle abnormalities received treatment.
Prespecified analyses of the outcomes in the subgroup of women who had routine hysteroscopy showed no statistically significant differences in the pregnancy or live-birth rates of the women with or without significant uterine abnormalities identified by hysteroscopy or in the women with or without subtle uterine abnormalities, Dr. El-Toukhy said.
Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures. Dr. Friese had no relevant disclosures.
On Twitter @mitchelzoler
AT ESHRE 2014
Key clinical point: Routine hysteroscopy prior to in vitro fertilization did not improve IVF outcomes in asymptomatic women with two to four prior miscarriages.
Major finding: The live-birth rate after IVF was 30% in women undergoing routine hysteroscopy and 29% in those with no hysteroscopy.
Data source: TROPHY, a prospective, randomized, controlled trial with 656 evaluable women treated at eight centers in four European countries.
Disclosures: Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures.
Routine hysteroscopy failed to aid recurrent miscarriages
MUNICH – Routine hysteroscopy and treatment of uterine abnormalities found by using it failed to improve the live-birth rate after in vitro fertilization in asymptomatic women with no ultrasound findings who already had failed two to four attempts at pregnancy and delivery with IVF, in a randomized, controlled trial of 656 women.
"Out-patient hysteroscopy cannot be routinely recommended after recurrent in vitro fertilization failure," concluded Dr. Tarek El-Toukhy at the annual meeting of the European Society of Human Reproduction and Embryology.
Based on these findings, hysteroscopy should be limited to women with clinical symptoms or ultrasound findings that suggest an abnormality in the uterine cavity, but hysteroscopy should not be performed routinely in all women who have a history of multiple miscarriages, said Dr. El-Toukhy, a gynecologist at Guy’s and St. Thomas’ Hospital in London.
The study results indicated that roughly one in nine of the enrolled women had a uterine abnormality that was detectable by hysteroscopy, but finding and correcting these problems had no effect on pregnancy outcomes.
Seeing these data, "I have the impression that [routine hysteroscopy] is of no use. The study was well done," commented Dr. Klaus Friese, a gynecologist and director of the Women’s Hospital of the University of Munich.
"When you see something unusual by ultrasound or if you suspect a problem, then you should do hysteroscopy, but not just because the women had three miscarriages when the ultrasound shows nothing," Dr. Friese said in an interview.
The findings also suggest that when multiple miscarriages occur following IVF, embryo factors are often involved rather than issues in the mother, said Dr. El-Toukhy. "Even when women had a uterine issue, treatment did not help. That lends more importance to embryo factors. Uterine factors can be important, but not as important as embryo factors" to explain multiple miscarriages following IVF, he said.
The TROPHY (Trial of Outpatient Hysteroscopy) study was run at eight centers in four European countries. The investigators randomized women who were younger than 38 years and who had a body mass index of less than 35 kg/m2, a history of two to four prior miscarriages following IVF, and a normal-appearing uterus when assessed by transvaginal ultrasonography. Woman randomized to routine hysteroscopy had the procedure done using a Campo Trophyscope marketed by Karl Storz. Uterine abnormalities found by routine hysteroscopy were treated when appropriate. All women enrolled then underwent ovarian stimulation and IVF using usual local protocols.
At the end of the study, the 332 women randomized to routine hysteroscopy with evaluable follow-up had a 39% pregnancy rate and a 30% live-birth rate, not statistically different from the 39% pregnancy rate and 29% live-birth rate seen among 324 evaluable women randomized to no hysteroscopy, Dr. El-Toukhy reported.
In the women randomized to routine hysteroscopy, 11% showed a significant abnormality on examination, including 15 women with an arcuate uterus, 11 women with endometrial polyps, and five women with a partial septum, as well as women with a few other less common abnormalities. Fifteen women underwent a surgical procedure to address abnormalities found by hysteroscopy. Hysteroscopy also found one or more "subtle" abnormalities in 13% of the examined women, a category for abnormalities of uncertain significance that included hypervascularization of the uterus (20 women) and mucosal elevation (13 women). None of the subtle abnormalities received treatment.
Prespecified analyses of the outcomes in the subgroup of women who had routine hysteroscopy showed no statistically significant differences in the pregnancy or live-birth rates of the women with or without significant uterine abnormalities identified by hysteroscopy or in the women with or without subtle uterine abnormalities, Dr. El-Toukhy said.
Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures. Dr. Friese had no relevant disclosures.
On Twitter @mitchelzoler
MUNICH – Routine hysteroscopy and treatment of uterine abnormalities found by using it failed to improve the live-birth rate after in vitro fertilization in asymptomatic women with no ultrasound findings who already had failed two to four attempts at pregnancy and delivery with IVF, in a randomized, controlled trial of 656 women.
"Out-patient hysteroscopy cannot be routinely recommended after recurrent in vitro fertilization failure," concluded Dr. Tarek El-Toukhy at the annual meeting of the European Society of Human Reproduction and Embryology.
Based on these findings, hysteroscopy should be limited to women with clinical symptoms or ultrasound findings that suggest an abnormality in the uterine cavity, but hysteroscopy should not be performed routinely in all women who have a history of multiple miscarriages, said Dr. El-Toukhy, a gynecologist at Guy’s and St. Thomas’ Hospital in London.
The study results indicated that roughly one in nine of the enrolled women had a uterine abnormality that was detectable by hysteroscopy, but finding and correcting these problems had no effect on pregnancy outcomes.
Seeing these data, "I have the impression that [routine hysteroscopy] is of no use. The study was well done," commented Dr. Klaus Friese, a gynecologist and director of the Women’s Hospital of the University of Munich.
"When you see something unusual by ultrasound or if you suspect a problem, then you should do hysteroscopy, but not just because the women had three miscarriages when the ultrasound shows nothing," Dr. Friese said in an interview.
The findings also suggest that when multiple miscarriages occur following IVF, embryo factors are often involved rather than issues in the mother, said Dr. El-Toukhy. "Even when women had a uterine issue, treatment did not help. That lends more importance to embryo factors. Uterine factors can be important, but not as important as embryo factors" to explain multiple miscarriages following IVF, he said.
The TROPHY (Trial of Outpatient Hysteroscopy) study was run at eight centers in four European countries. The investigators randomized women who were younger than 38 years and who had a body mass index of less than 35 kg/m2, a history of two to four prior miscarriages following IVF, and a normal-appearing uterus when assessed by transvaginal ultrasonography. Woman randomized to routine hysteroscopy had the procedure done using a Campo Trophyscope marketed by Karl Storz. Uterine abnormalities found by routine hysteroscopy were treated when appropriate. All women enrolled then underwent ovarian stimulation and IVF using usual local protocols.
At the end of the study, the 332 women randomized to routine hysteroscopy with evaluable follow-up had a 39% pregnancy rate and a 30% live-birth rate, not statistically different from the 39% pregnancy rate and 29% live-birth rate seen among 324 evaluable women randomized to no hysteroscopy, Dr. El-Toukhy reported.
In the women randomized to routine hysteroscopy, 11% showed a significant abnormality on examination, including 15 women with an arcuate uterus, 11 women with endometrial polyps, and five women with a partial septum, as well as women with a few other less common abnormalities. Fifteen women underwent a surgical procedure to address abnormalities found by hysteroscopy. Hysteroscopy also found one or more "subtle" abnormalities in 13% of the examined women, a category for abnormalities of uncertain significance that included hypervascularization of the uterus (20 women) and mucosal elevation (13 women). None of the subtle abnormalities received treatment.
Prespecified analyses of the outcomes in the subgroup of women who had routine hysteroscopy showed no statistically significant differences in the pregnancy or live-birth rates of the women with or without significant uterine abnormalities identified by hysteroscopy or in the women with or without subtle uterine abnormalities, Dr. El-Toukhy said.
Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures. Dr. Friese had no relevant disclosures.
On Twitter @mitchelzoler
MUNICH – Routine hysteroscopy and treatment of uterine abnormalities found by using it failed to improve the live-birth rate after in vitro fertilization in asymptomatic women with no ultrasound findings who already had failed two to four attempts at pregnancy and delivery with IVF, in a randomized, controlled trial of 656 women.
"Out-patient hysteroscopy cannot be routinely recommended after recurrent in vitro fertilization failure," concluded Dr. Tarek El-Toukhy at the annual meeting of the European Society of Human Reproduction and Embryology.
Based on these findings, hysteroscopy should be limited to women with clinical symptoms or ultrasound findings that suggest an abnormality in the uterine cavity, but hysteroscopy should not be performed routinely in all women who have a history of multiple miscarriages, said Dr. El-Toukhy, a gynecologist at Guy’s and St. Thomas’ Hospital in London.
The study results indicated that roughly one in nine of the enrolled women had a uterine abnormality that was detectable by hysteroscopy, but finding and correcting these problems had no effect on pregnancy outcomes.
Seeing these data, "I have the impression that [routine hysteroscopy] is of no use. The study was well done," commented Dr. Klaus Friese, a gynecologist and director of the Women’s Hospital of the University of Munich.
"When you see something unusual by ultrasound or if you suspect a problem, then you should do hysteroscopy, but not just because the women had three miscarriages when the ultrasound shows nothing," Dr. Friese said in an interview.
The findings also suggest that when multiple miscarriages occur following IVF, embryo factors are often involved rather than issues in the mother, said Dr. El-Toukhy. "Even when women had a uterine issue, treatment did not help. That lends more importance to embryo factors. Uterine factors can be important, but not as important as embryo factors" to explain multiple miscarriages following IVF, he said.
The TROPHY (Trial of Outpatient Hysteroscopy) study was run at eight centers in four European countries. The investigators randomized women who were younger than 38 years and who had a body mass index of less than 35 kg/m2, a history of two to four prior miscarriages following IVF, and a normal-appearing uterus when assessed by transvaginal ultrasonography. Woman randomized to routine hysteroscopy had the procedure done using a Campo Trophyscope marketed by Karl Storz. Uterine abnormalities found by routine hysteroscopy were treated when appropriate. All women enrolled then underwent ovarian stimulation and IVF using usual local protocols.
At the end of the study, the 332 women randomized to routine hysteroscopy with evaluable follow-up had a 39% pregnancy rate and a 30% live-birth rate, not statistically different from the 39% pregnancy rate and 29% live-birth rate seen among 324 evaluable women randomized to no hysteroscopy, Dr. El-Toukhy reported.
In the women randomized to routine hysteroscopy, 11% showed a significant abnormality on examination, including 15 women with an arcuate uterus, 11 women with endometrial polyps, and five women with a partial septum, as well as women with a few other less common abnormalities. Fifteen women underwent a surgical procedure to address abnormalities found by hysteroscopy. Hysteroscopy also found one or more "subtle" abnormalities in 13% of the examined women, a category for abnormalities of uncertain significance that included hypervascularization of the uterus (20 women) and mucosal elevation (13 women). None of the subtle abnormalities received treatment.
Prespecified analyses of the outcomes in the subgroup of women who had routine hysteroscopy showed no statistically significant differences in the pregnancy or live-birth rates of the women with or without significant uterine abnormalities identified by hysteroscopy or in the women with or without subtle uterine abnormalities, Dr. El-Toukhy said.
Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures. Dr. Friese had no relevant disclosures.
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AT ESHRE 2014
Key clinical point: Routine hysteroscopy prior to in vitro fertilization did not improve IVF outcomes in asymptomatic women with two to four prior miscarriages.
Major finding: The live-birth rate after IVF was 30% in women undergoing routine hysteroscopy and 29% in those with no hysteroscopy.
Data source: TROPHY, a prospective, randomized, controlled trial with 656 evaluable women treated at eight centers in four European countries.
Disclosures: Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures.
