Kate Johnson

One of the largest studies to examine the long-term health effects of cosmetic breast implants has found little evidence to advance the debate about whether implants are linked to connective tissue disease.

The retrospective cohort study by the National Cancer Institute was primarily designed to assess cancer occurrence and overall mortality patterns among implant recipients.

Several published reports on that cohort showed no association between implants and subsequent risk of breast cancer or most other cancers.

However, a two- to threefold increase in the rates of respiratory and brain cancers and a four- to fivefold increase in suicide rates were found among women with implants, compared with control patients. (For references, see the NCI's fact sheet at www.nci.nih.gov/newscenter/siliconefactsheet

Findings linking implants with connective tissue disorders (CTDs), however, are far less conclusive.

"Given the diagnostic complexities of these diseases, excess risks, if they exist, may be beyond detection even in a study of this size," wrote principal author Louise A. Brinton, Ph.D., of the National Cancer Institute, Rockville, Md. (Am. J. Epidemiol. 2004;160:619–27).

"The design of the study did not enable us to derive any firm conclusions, but we were able to rule out very large increased risks," she told this newspaper.

Roughly half the 7,234 breast augmentation recipients (49.7%) had received silicone implants, while about 34% received double lumen implants, about 12% received saline implants, and about 4% received other or unspecified implant types.

The 2,138 control patients were of similar age and had had other types of plastic surgery not involving silicone, such as abdominoplasty or liposuction; blepharoplasty or rhytidectomy; and rhinoplasty, otoplasty, mentoplasty, or genioplasty.

Surgeries in both groups had taken place between 1983 and 1984.

Study subjects were mailed questionnaires about demographic information, subsequent plastic surgeries, current health status, and lifestyle factors that could affect their health. They were asked whether they had a physician's diagnosis of a CTD—including rheumatoid arthritis (RA), arthritis of another type, scleroderma, systemic lupus erythematosus (SLE), Sjögren's syndrome, Raynaud's phenomenon, fibrositis/fibromyalgia, vasculitis, chronic fatigue syndrome, or multiple sclerosis.

The study found that 4.8% of implant patients reported a diagnosis of one of four major CTDs (RA, scleroderma, SLE, or Sjögren's syndrome), compared with 2.9% of controls, representing a relative risk of 2.0. This risk elevation was statistically significant, but after controlling for various confounding factors, the investigators concluded that the risks were not significant.

One limitation is that risk estimates were based on patient reports of their CTD diagnosis, rather than on a physician's report.

Two rheumatologists blinded to the implant status of the patients reviewed medical records to determine if each participant's history, physical examination, and radiographic and laboratory findings supported the CTD diagnosis. They then rated each CTD diagnosis as "likely," "unlikely," or "unable to assess."

Although the reviewers were able to access the medical records of only 30%–40% of study participants, they concluded that "most diagnoses were insufficiently supported, either because the records were incomplete or because clinical criteria were not met."

When relative risks were recalculated using only the "likely" diagnoses, the revised estimated relative risk for RA, scleroderma, and Sjögren's syndrome combined was still 2.0, and for RA alone it was 1.3, both of which were not statistically significant, given the smaller sample size.

"We were relying on self-reports of these conditions that even rheumatologists have a hard time diagnosing, and …many of these conditions are extremely rare. So we ended up with very small numbers, and it was really not possible to either confirm or refute whether there is an association," said Dr. Brinton.

The investigators note that their observations of selection and reporting biases underscore the complexities of evaluating the relationship of implants and CTDs.

"Thus, future studies designed to resolve the question of a possible association between breast implants and rheumatoid arthritis or other CTDs would need to be very large and include well-validated and documented cases and unbiased assessments of exposure," they said.

"There were a lot of methodological problems with this study, and the authors did a good job of outlining them," commented Diana Zuckerman, Ph.D., president of the National Center for Policy Research for Women & Families, a Washington-based nonprofit group. "This is the latest of several red flags warning women that the risks of breast implants have not been adequately studied," she said in an interview.

One of the largest studies to examine the long-term health effects of cosmetic breast implants has found little evidence to advance the debate about whether implants are linked to connective tissue disease.

The retrospective cohort study by the National Cancer Institute was primarily designed to assess cancer occurrence and overall mortality patterns among implant recipients.

Several published reports on that cohort showed no association between implants and subsequent risk of breast cancer or most other cancers.

However, a two- to threefold increase in the rates of respiratory and brain cancers and a four- to fivefold increase in suicide rates were found among women with implants, compared with control patients. (For references, see the NCI's fact sheet at www.nci.nih.gov/newscenter/siliconefactsheet

Findings linking implants with connective tissue disorders (CTDs), however, are far less conclusive.

"Given the diagnostic complexities of these diseases, excess risks, if they exist, may be beyond detection even in a study of this size," wrote principal author Louise A. Brinton, Ph.D., of the National Cancer Institute, Rockville, Md. (Am. J. Epidemiol. 2004;160:619–27).

"The design of the study did not enable us to derive any firm conclusions, but we were able to rule out very large increased risks," she told this newspaper.

Roughly half the 7,234 breast augmentation recipients (49.7%) had received silicone implants, while about 34% received double lumen implants, about 12% received saline implants, and about 4% received other or unspecified implant types.

The 2,138 control patients were of similar age and had had other types of plastic surgery not involving silicone, such as abdominoplasty or liposuction; blepharoplasty or rhytidectomy; and rhinoplasty, otoplasty, mentoplasty, or genioplasty.

Surgeries in both groups had taken place between 1983 and 1984.

Study subjects were mailed questionnaires about demographic information, subsequent plastic surgeries, current health status, and lifestyle factors that could affect their health. They were asked whether they had a physician's diagnosis of a CTD—including rheumatoid arthritis (RA), arthritis of another type, scleroderma, systemic lupus erythematosus (SLE), Sjögren's syndrome, Raynaud's phenomenon, fibrositis/fibromyalgia, vasculitis, chronic fatigue syndrome, or multiple sclerosis.

The study found that 4.8% of implant patients reported a diagnosis of one of four major CTDs (RA, scleroderma, SLE, or Sjögren's syndrome), compared with 2.9% of controls, representing a relative risk of 2.0. This risk elevation was statistically significant, but after controlling for various confounding factors, the investigators concluded that the risks were not significant.

One limitation is that risk estimates were based on patient reports of their CTD diagnosis, rather than on a physician's report.

Two rheumatologists blinded to the implant status of the patients reviewed medical records to determine if each participant's history, physical examination, and radiographic and laboratory findings supported the CTD diagnosis. They then rated each CTD diagnosis as "likely," "unlikely," or "unable to assess."

Although the reviewers were able to access the medical records of only 30%–40% of study participants, they concluded that "most diagnoses were insufficiently supported, either because the records were incomplete or because clinical criteria were not met."

When relative risks were recalculated using only the "likely" diagnoses, the revised estimated relative risk for RA, scleroderma, and Sjögren's syndrome combined was still 2.0, and for RA alone it was 1.3, both of which were not statistically significant, given the smaller sample size.

"We were relying on self-reports of these conditions that even rheumatologists have a hard time diagnosing, and …many of these conditions are extremely rare. So we ended up with very small numbers, and it was really not possible to either confirm or refute whether there is an association," said Dr. Brinton.

The investigators note that their observations of selection and reporting biases underscore the complexities of evaluating the relationship of implants and CTDs.

"Thus, future studies designed to resolve the question of a possible association between breast implants and rheumatoid arthritis or other CTDs would need to be very large and include well-validated and documented cases and unbiased assessments of exposure," they said.

"There were a lot of methodological problems with this study, and the authors did a good job of outlining them," commented Diana Zuckerman, Ph.D., president of the National Center for Policy Research for Women & Families, a Washington-based nonprofit group. "This is the latest of several red flags warning women that the risks of breast implants have not been adequately studied," she said in an interview.

One of the largest studies to examine the long-term health effects of cosmetic breast implants has found little evidence to advance the debate about whether implants are linked to connective tissue disease.

The retrospective cohort study by the National Cancer Institute was primarily designed to assess cancer occurrence and overall mortality patterns among implant recipients.

Several published reports on that cohort showed no association between implants and subsequent risk of breast cancer or most other cancers.

However, a two- to threefold increase in the rates of respiratory and brain cancers and a four- to fivefold increase in suicide rates were found among women with implants, compared with control patients. (For references, see the NCI's fact sheet at www.nci.nih.gov/newscenter/siliconefactsheet

Findings linking implants with connective tissue disorders (CTDs), however, are far less conclusive.

"Given the diagnostic complexities of these diseases, excess risks, if they exist, may be beyond detection even in a study of this size," wrote principal author Louise A. Brinton, Ph.D., of the National Cancer Institute, Rockville, Md. (Am. J. Epidemiol. 2004;160:619–27).

"The design of the study did not enable us to derive any firm conclusions, but we were able to rule out very large increased risks," she told this newspaper.

Roughly half the 7,234 breast augmentation recipients (49.7%) had received silicone implants, while about 34% received double lumen implants, about 12% received saline implants, and about 4% received other or unspecified implant types.

The 2,138 control patients were of similar age and had had other types of plastic surgery not involving silicone, such as abdominoplasty or liposuction; blepharoplasty or rhytidectomy; and rhinoplasty, otoplasty, mentoplasty, or genioplasty.

Surgeries in both groups had taken place between 1983 and 1984.

Study subjects were mailed questionnaires about demographic information, subsequent plastic surgeries, current health status, and lifestyle factors that could affect their health. They were asked whether they had a physician's diagnosis of a CTD—including rheumatoid arthritis (RA), arthritis of another type, scleroderma, systemic lupus erythematosus (SLE), Sjögren's syndrome, Raynaud's phenomenon, fibrositis/fibromyalgia, vasculitis, chronic fatigue syndrome, or multiple sclerosis.

The study found that 4.8% of implant patients reported a diagnosis of one of four major CTDs (RA, scleroderma, SLE, or Sjögren's syndrome), compared with 2.9% of controls, representing a relative risk of 2.0. This risk elevation was statistically significant, but after controlling for various confounding factors, the investigators concluded that the risks were not significant.

One limitation is that risk estimates were based on patient reports of their CTD diagnosis, rather than on a physician's report.

Two rheumatologists blinded to the implant status of the patients reviewed medical records to determine if each participant's history, physical examination, and radiographic and laboratory findings supported the CTD diagnosis. They then rated each CTD diagnosis as "likely," "unlikely," or "unable to assess."

Although the reviewers were able to access the medical records of only 30%–40% of study participants, they concluded that "most diagnoses were insufficiently supported, either because the records were incomplete or because clinical criteria were not met."

When relative risks were recalculated using only the "likely" diagnoses, the revised estimated relative risk for RA, scleroderma, and Sjögren's syndrome combined was still 2.0, and for RA alone it was 1.3, both of which were not statistically significant, given the smaller sample size.

"We were relying on self-reports of these conditions that even rheumatologists have a hard time diagnosing, and …many of these conditions are extremely rare. So we ended up with very small numbers, and it was really not possible to either confirm or refute whether there is an association," said Dr. Brinton.

The investigators note that their observations of selection and reporting biases underscore the complexities of evaluating the relationship of implants and CTDs.

"Thus, future studies designed to resolve the question of a possible association between breast implants and rheumatoid arthritis or other CTDs would need to be very large and include well-validated and documented cases and unbiased assessments of exposure," they said.

"There were a lot of methodological problems with this study, and the authors did a good job of outlining them," commented Diana Zuckerman, Ph.D., president of the National Center for Policy Research for Women & Families, a Washington-based nonprofit group. "This is the latest of several red flags warning women that the risks of breast implants have not been adequately studied," she said in an interview.

PHILADELPHIA — Women with a self-reported history of infertility are more likely than fertile women to experience night sweats when they reach the perimenopause, according to Brandon J. Bankowski, M.D.

“This is a unique observation,” he said at the annual meeting of the American Society for Reproductive Medicine.

“Women who experience these menopausal symptoms may have had something going on throughout their lives that manifested itself as infertility earlier on and then as night sweats later,” he told this newspaper.

Dr. Bankowski and his associates recruited 435 women between 45 and 54 years of age with an intact uterus, ovaries, and at least three menstrual periods in the last year. The women provided one blood sample for the measurement of their estradiol (E2) and estrone (E1) levels. They also completed an extensive questionnaire regarding personal demographics; parity; and reproductive history, including a specific question about their self-reported history of an inability to conceive within 1 year of trying.

Slightly more than one-quarter of the women (27%) reported a history of infertility, and these women had no other significant differences in baseline characteristics, compared with controls.

When study participants were asked about 10 different menopausal symptoms, the only significant difference between the women with infertility cases and controls was in their reporting of night sweats, said Dr. Bankowski, a fellow in reproductive medicine at Johns Hopkins University, Baltimore.

Infertile patients were more likely to report night sweats in every frequency category. For example, 26% of the infertile women reported one episode of night sweats per night, compared with none of the controls. Almost 14% of the infertile women reported two episodes per night, compared with 4% of controls. Almost 5% of infertile women but none of the controls indicated they had more than four episodes per night. Blood tests on all the women revealed no differences in hormonal levels between the cases and controls.

“It's possible there's a common underlying mechanism that's creating both the infertility and the night sweats. This is important with regard to prevention and treatment,” he said.

Dr. Bankowski said they hope next to follow infertile patients prospectively to see if they develop more night sweats than fertile controls.

PHILADELPHIA — Women with a self-reported history of infertility are more likely than fertile women to experience night sweats when they reach the perimenopause, according to Brandon J. Bankowski, M.D.

“This is a unique observation,” he said at the annual meeting of the American Society for Reproductive Medicine.

“Women who experience these menopausal symptoms may have had something going on throughout their lives that manifested itself as infertility earlier on and then as night sweats later,” he told this newspaper.

Dr. Bankowski and his associates recruited 435 women between 45 and 54 years of age with an intact uterus, ovaries, and at least three menstrual periods in the last year. The women provided one blood sample for the measurement of their estradiol (E2) and estrone (E1) levels. They also completed an extensive questionnaire regarding personal demographics; parity; and reproductive history, including a specific question about their self-reported history of an inability to conceive within 1 year of trying.

Slightly more than one-quarter of the women (27%) reported a history of infertility, and these women had no other significant differences in baseline characteristics, compared with controls.

When study participants were asked about 10 different menopausal symptoms, the only significant difference between the women with infertility cases and controls was in their reporting of night sweats, said Dr. Bankowski, a fellow in reproductive medicine at Johns Hopkins University, Baltimore.

Infertile patients were more likely to report night sweats in every frequency category. For example, 26% of the infertile women reported one episode of night sweats per night, compared with none of the controls. Almost 14% of the infertile women reported two episodes per night, compared with 4% of controls. Almost 5% of infertile women but none of the controls indicated they had more than four episodes per night. Blood tests on all the women revealed no differences in hormonal levels between the cases and controls.

“It's possible there's a common underlying mechanism that's creating both the infertility and the night sweats. This is important with regard to prevention and treatment,” he said.

Dr. Bankowski said they hope next to follow infertile patients prospectively to see if they develop more night sweats than fertile controls.

PHILADELPHIA — Women with a self-reported history of infertility are more likely than fertile women to experience night sweats when they reach the perimenopause, according to Brandon J. Bankowski, M.D.

“This is a unique observation,” he said at the annual meeting of the American Society for Reproductive Medicine.

“Women who experience these menopausal symptoms may have had something going on throughout their lives that manifested itself as infertility earlier on and then as night sweats later,” he told this newspaper.

Dr. Bankowski and his associates recruited 435 women between 45 and 54 years of age with an intact uterus, ovaries, and at least three menstrual periods in the last year. The women provided one blood sample for the measurement of their estradiol (E2) and estrone (E1) levels. They also completed an extensive questionnaire regarding personal demographics; parity; and reproductive history, including a specific question about their self-reported history of an inability to conceive within 1 year of trying.

Slightly more than one-quarter of the women (27%) reported a history of infertility, and these women had no other significant differences in baseline characteristics, compared with controls.

When study participants were asked about 10 different menopausal symptoms, the only significant difference between the women with infertility cases and controls was in their reporting of night sweats, said Dr. Bankowski, a fellow in reproductive medicine at Johns Hopkins University, Baltimore.

Infertile patients were more likely to report night sweats in every frequency category. For example, 26% of the infertile women reported one episode of night sweats per night, compared with none of the controls. Almost 14% of the infertile women reported two episodes per night, compared with 4% of controls. Almost 5% of infertile women but none of the controls indicated they had more than four episodes per night. Blood tests on all the women revealed no differences in hormonal levels between the cases and controls.

“It's possible there's a common underlying mechanism that's creating both the infertility and the night sweats. This is important with regard to prevention and treatment,” he said.

Dr. Bankowski said they hope next to follow infertile patients prospectively to see if they develop more night sweats than fertile controls.

CHICAGO — Children with attention-deficit hyperactivity disorder have anatomical brain abnormalities that can be seen with a novel technique called diffusion tensor imaging.

“Our hope is, in the future, to be able to diagnose ADHD with this technique,” said lead investigator Manzar Ashtari, Ph.D., of North Shore-Long Island Jewish Health System in New Hyde Park, N.Y.

Speaking at a press conference at the annual meeting of the Radiological Society of North America, Dr. Ashtari explained that until now, imaging of the brain in patients with ADHD has revealed mostly macroscopic findings.

“For example, we know that the frontal lobe and cerebellum are smaller in these patients.”

But she said her work with diffusion tensor imaging (DTI) looks deeper—at a more microscopic level—showing abnormalities in the corticopontocerebellar circuit, the fiber pathways that communicate between the frontal lobe and the cerebellum.

The study compared DTI of the brain in 18 children with ADHD, aged 7–11 years, and 15 healthy controls matched for age, sex, and socioeconomic status.

“We found abnormalities in the fiber pathways in the frontal cortex, basal ganglia, brain stem, and cerebellum in the ADHD patients,” she said, explaining that these areas of the brain regulate attention, impulsive behavior, motor activity, and inhibition. “These findings suggest that the circuit which connects the frontal lobe and the cerebellum is not efficient in ADHD.”

Dr. Ashtari was also co-lead investigator on a second study that used DTI to compare the brain anatomy of 20 children with ADHD, half of whom were medicated for their condition, and half of whom were medication naive.

Fiber pathway abnormalities are less pronounced in children who have been treated with stimulant medication, compared with those who have not.

“These results are definitely very exciting,” said Dr. Ashtari. “They suggest that perhaps the medication is doing something to normalize the brain abnormalities, such as remyelinating the axons.”

However, she cautions against jumping to the conclusion that the study shows stimulants can reverse, or partially correct, the brain abnormalities seen in ADHD.

“Other studies into the effect of medication have shown that the white matter of the brain increases to close to normal in medicated children. But medicated children also are usually older. So could the improvement be just an effect of age—as the brain grows?” Dr Ashtari discussed with FAMILY PRACTICE NEWS.

“The more conclusive study will be to follow drug-naive children prospectively and then see what happens when you medicate them,” she said, adding that her team has received funding to start this study.

While brain imaging using MRI has mostly revealed macro-scopic findings, DTI shows a more microscopic view.

DTI shows frontal cortex and cerebellum abnormalities in an ADHD patient. Photos courtesy Dr. Manzar Ashtari

CHICAGO — Children with attention-deficit hyperactivity disorder have anatomical brain abnormalities that can be seen with a novel technique called diffusion tensor imaging.

“Our hope is, in the future, to be able to diagnose ADHD with this technique,” said lead investigator Manzar Ashtari, Ph.D., of North Shore-Long Island Jewish Health System in New Hyde Park, N.Y.

Speaking at a press conference at the annual meeting of the Radiological Society of North America, Dr. Ashtari explained that until now, imaging of the brain in patients with ADHD has revealed mostly macroscopic findings.

“For example, we know that the frontal lobe and cerebellum are smaller in these patients.”

But she said her work with diffusion tensor imaging (DTI) looks deeper—at a more microscopic level—showing abnormalities in the corticopontocerebellar circuit, the fiber pathways that communicate between the frontal lobe and the cerebellum.

The study compared DTI of the brain in 18 children with ADHD, aged 7–11 years, and 15 healthy controls matched for age, sex, and socioeconomic status.

“We found abnormalities in the fiber pathways in the frontal cortex, basal ganglia, brain stem, and cerebellum in the ADHD patients,” she said, explaining that these areas of the brain regulate attention, impulsive behavior, motor activity, and inhibition. “These findings suggest that the circuit which connects the frontal lobe and the cerebellum is not efficient in ADHD.”

Dr. Ashtari was also co-lead investigator on a second study that used DTI to compare the brain anatomy of 20 children with ADHD, half of whom were medicated for their condition, and half of whom were medication naive.

Fiber pathway abnormalities are less pronounced in children who have been treated with stimulant medication, compared with those who have not.

“These results are definitely very exciting,” said Dr. Ashtari. “They suggest that perhaps the medication is doing something to normalize the brain abnormalities, such as remyelinating the axons.”

However, she cautions against jumping to the conclusion that the study shows stimulants can reverse, or partially correct, the brain abnormalities seen in ADHD.

“Other studies into the effect of medication have shown that the white matter of the brain increases to close to normal in medicated children. But medicated children also are usually older. So could the improvement be just an effect of age—as the brain grows?” Dr Ashtari discussed with FAMILY PRACTICE NEWS.

“The more conclusive study will be to follow drug-naive children prospectively and then see what happens when you medicate them,” she said, adding that her team has received funding to start this study.

While brain imaging using MRI has mostly revealed macro-scopic findings, DTI shows a more microscopic view.

DTI shows frontal cortex and cerebellum abnormalities in an ADHD patient. Photos courtesy Dr. Manzar Ashtari

CHICAGO — Children with attention-deficit hyperactivity disorder have anatomical brain abnormalities that can be seen with a novel technique called diffusion tensor imaging.

“Our hope is, in the future, to be able to diagnose ADHD with this technique,” said lead investigator Manzar Ashtari, Ph.D., of North Shore-Long Island Jewish Health System in New Hyde Park, N.Y.

Speaking at a press conference at the annual meeting of the Radiological Society of North America, Dr. Ashtari explained that until now, imaging of the brain in patients with ADHD has revealed mostly macroscopic findings.

“For example, we know that the frontal lobe and cerebellum are smaller in these patients.”

But she said her work with diffusion tensor imaging (DTI) looks deeper—at a more microscopic level—showing abnormalities in the corticopontocerebellar circuit, the fiber pathways that communicate between the frontal lobe and the cerebellum.

The study compared DTI of the brain in 18 children with ADHD, aged 7–11 years, and 15 healthy controls matched for age, sex, and socioeconomic status.

“We found abnormalities in the fiber pathways in the frontal cortex, basal ganglia, brain stem, and cerebellum in the ADHD patients,” she said, explaining that these areas of the brain regulate attention, impulsive behavior, motor activity, and inhibition. “These findings suggest that the circuit which connects the frontal lobe and the cerebellum is not efficient in ADHD.”

Dr. Ashtari was also co-lead investigator on a second study that used DTI to compare the brain anatomy of 20 children with ADHD, half of whom were medicated for their condition, and half of whom were medication naive.

Fiber pathway abnormalities are less pronounced in children who have been treated with stimulant medication, compared with those who have not.

“These results are definitely very exciting,” said Dr. Ashtari. “They suggest that perhaps the medication is doing something to normalize the brain abnormalities, such as remyelinating the axons.”

However, she cautions against jumping to the conclusion that the study shows stimulants can reverse, or partially correct, the brain abnormalities seen in ADHD.

“Other studies into the effect of medication have shown that the white matter of the brain increases to close to normal in medicated children. But medicated children also are usually older. So could the improvement be just an effect of age—as the brain grows?” Dr Ashtari discussed with FAMILY PRACTICE NEWS.

“The more conclusive study will be to follow drug-naive children prospectively and then see what happens when you medicate them,” she said, adding that her team has received funding to start this study.

While brain imaging using MRI has mostly revealed macro-scopic findings, DTI shows a more microscopic view.

DTI shows frontal cortex and cerebellum abnormalities in an ADHD patient. Photos courtesy Dr. Manzar Ashtari

ST. LOUIS — The presence of bacterial vaginosis at the time of pelvic surgery can be easily detected if a patient's vaginal pH is checked in the operating room on the day of surgery, according to S. Robert Kovac, M.D.

“BV is associated with a much higher degree of cuff cellulitis, but if we test a patient 2 months or even 2 weeks before surgery, we have no way of knowing if she has been effectively treated or reinfected by the time she comes back for surgery,” he said at the 14th International Pelvic Reconstructive and Vaginal Surgery Conference.

A pH of more than 4.5 on the day of surgery indicates an abnormality, which is most commonly BV, said Dr. Kovac of Emory University, Atlanta, which sponsored the conference, along with the Society of Pelvic Reconstructive Surgeons.

Such patients should be treated therapeutically with 500 mg of Flagyl orally, twice a day for 5 days, starting on the second day after surgery. They also should receive the standard prophylaxis at the time of surgery.

Measuring vaginal pH is a simple method for detecting abnormalities, but it is rarely done, he said, adding that it would be a useful self-test for patients who suspect a vaginal infection. If a woman thought she had a vaginal infection and could measure her vaginal pH, it would avoid mistreatment for yeast infections and a missed diagnosis of BV.

“A vaginal yeast infection would have a pH of 4.5 or less, whereas with a reading of 5.5 or 6, this is usually BV,” Dr. Kovac explained.

The pH test would also help physicians. “Many physicians even today don't look under the microscope in their own offices,” he said.

“And even if they do, 50% of the time the bacteria that they expect to see may be there, but it is not detectable. The simplest thing to do is vaginal pH. It tells you a great deal,” Dr. Kovac said.

ST. LOUIS — The presence of bacterial vaginosis at the time of pelvic surgery can be easily detected if a patient's vaginal pH is checked in the operating room on the day of surgery, according to S. Robert Kovac, M.D.

“BV is associated with a much higher degree of cuff cellulitis, but if we test a patient 2 months or even 2 weeks before surgery, we have no way of knowing if she has been effectively treated or reinfected by the time she comes back for surgery,” he said at the 14th International Pelvic Reconstructive and Vaginal Surgery Conference.

A pH of more than 4.5 on the day of surgery indicates an abnormality, which is most commonly BV, said Dr. Kovac of Emory University, Atlanta, which sponsored the conference, along with the Society of Pelvic Reconstructive Surgeons.

Such patients should be treated therapeutically with 500 mg of Flagyl orally, twice a day for 5 days, starting on the second day after surgery. They also should receive the standard prophylaxis at the time of surgery.

Measuring vaginal pH is a simple method for detecting abnormalities, but it is rarely done, he said, adding that it would be a useful self-test for patients who suspect a vaginal infection. If a woman thought she had a vaginal infection and could measure her vaginal pH, it would avoid mistreatment for yeast infections and a missed diagnosis of BV.

“A vaginal yeast infection would have a pH of 4.5 or less, whereas with a reading of 5.5 or 6, this is usually BV,” Dr. Kovac explained.

The pH test would also help physicians. “Many physicians even today don't look under the microscope in their own offices,” he said.

“And even if they do, 50% of the time the bacteria that they expect to see may be there, but it is not detectable. The simplest thing to do is vaginal pH. It tells you a great deal,” Dr. Kovac said.

ST. LOUIS — The presence of bacterial vaginosis at the time of pelvic surgery can be easily detected if a patient's vaginal pH is checked in the operating room on the day of surgery, according to S. Robert Kovac, M.D.

“BV is associated with a much higher degree of cuff cellulitis, but if we test a patient 2 months or even 2 weeks before surgery, we have no way of knowing if she has been effectively treated or reinfected by the time she comes back for surgery,” he said at the 14th International Pelvic Reconstructive and Vaginal Surgery Conference.

A pH of more than 4.5 on the day of surgery indicates an abnormality, which is most commonly BV, said Dr. Kovac of Emory University, Atlanta, which sponsored the conference, along with the Society of Pelvic Reconstructive Surgeons.

Such patients should be treated therapeutically with 500 mg of Flagyl orally, twice a day for 5 days, starting on the second day after surgery. They also should receive the standard prophylaxis at the time of surgery.

Measuring vaginal pH is a simple method for detecting abnormalities, but it is rarely done, he said, adding that it would be a useful self-test for patients who suspect a vaginal infection. If a woman thought she had a vaginal infection and could measure her vaginal pH, it would avoid mistreatment for yeast infections and a missed diagnosis of BV.

“A vaginal yeast infection would have a pH of 4.5 or less, whereas with a reading of 5.5 or 6, this is usually BV,” Dr. Kovac explained.

The pH test would also help physicians. “Many physicians even today don't look under the microscope in their own offices,” he said.

“And even if they do, 50% of the time the bacteria that they expect to see may be there, but it is not detectable. The simplest thing to do is vaginal pH. It tells you a great deal,” Dr. Kovac said.

PHILADELPHIA — Patients considering in vitro fertilization should be encouraged to aim for a healthy body mass index before they start treatment, results of a large retrospective study suggest.

“There was a trend toward decreasing success rates with increasing BMIs,” reported lead investigator David Ryley, M.D., of Beth Israel Deaconess Medical Center, Boston, and Boston IVF, a private fertility clinic.

The study reviewed more than 5,800 fresh, non-donor in vitro fertilization (IVF) cycles at Boston IVF in which the patient's BMI had been recorded, he reported at the annual meeting of the American Society for Reproductive Medicine.

Patients were divided into five groups according to BMI: under 20 kg/m

There was no difference between the groups with respect to the number of mature follicles, number of oocytes retrieved, number of mature oocytes, the number of cycles per patient, and the number of embryos transferred. Still, patients in the highest BMI category had a significantly lower implantation rate and clinical pregnancy rate, compared with the other BMI groups.

Although the clinical pregnancy rate ranged from about 27% to almost 33% in the lower BMI categories, it was not quite 22% in the highest BMI category.

Similarly, the implantation rate ranged from 18% to 20% in the lower BMI categories, but it was only 13% in the highest BMI category.

Unlike previous published studies on this topic, the current study did not find an association between extremely low BMI and poor IVF success rates, Dr. Ryley said.

“The best data in the literature suggest that severely low BMIs under 20, or under 18, affect the hypothalamic-pituitary axis, such that patients have irregular menstrual cycles and, therefore, have an impaired chance of fertility,” he told this newspaper. “But in our study the patients with the lowest BMIs actually had the highest pregnancy rates—although the difference was only significant when compared with the highest BMI category.”

The study's findings are consistent with other reports of how excess weight can impact hormonal balance and the quality of oocytes and embryos, he said. Weight loss can often correct problems such as hyperinsulinemia and polycystic ovarian syndrome, which can in turn increase fertility.

But physicians should also know how to manage an IVF cycle in an overweight patient who has not lost weight.

“We know that patients with high BMIs require higher doses of medications, particularly gonadotropins, to stimulate folliculogenesis, and they often require longer cycles,” Dr. Ryley said. “By increasing the doses of these medications, you can often get an adequate number of oocytes. However, in many of these patients, hormonal imbalances may have a deleterious effect on the quality of oocytes you get.”

PHILADELPHIA — Patients considering in vitro fertilization should be encouraged to aim for a healthy body mass index before they start treatment, results of a large retrospective study suggest.

“There was a trend toward decreasing success rates with increasing BMIs,” reported lead investigator David Ryley, M.D., of Beth Israel Deaconess Medical Center, Boston, and Boston IVF, a private fertility clinic.

The study reviewed more than 5,800 fresh, non-donor in vitro fertilization (IVF) cycles at Boston IVF in which the patient's BMI had been recorded, he reported at the annual meeting of the American Society for Reproductive Medicine.

Patients were divided into five groups according to BMI: under 20 kg/m

There was no difference between the groups with respect to the number of mature follicles, number of oocytes retrieved, number of mature oocytes, the number of cycles per patient, and the number of embryos transferred. Still, patients in the highest BMI category had a significantly lower implantation rate and clinical pregnancy rate, compared with the other BMI groups.

Although the clinical pregnancy rate ranged from about 27% to almost 33% in the lower BMI categories, it was not quite 22% in the highest BMI category.

Similarly, the implantation rate ranged from 18% to 20% in the lower BMI categories, but it was only 13% in the highest BMI category.

Unlike previous published studies on this topic, the current study did not find an association between extremely low BMI and poor IVF success rates, Dr. Ryley said.

“The best data in the literature suggest that severely low BMIs under 20, or under 18, affect the hypothalamic-pituitary axis, such that patients have irregular menstrual cycles and, therefore, have an impaired chance of fertility,” he told this newspaper. “But in our study the patients with the lowest BMIs actually had the highest pregnancy rates—although the difference was only significant when compared with the highest BMI category.”

The study's findings are consistent with other reports of how excess weight can impact hormonal balance and the quality of oocytes and embryos, he said. Weight loss can often correct problems such as hyperinsulinemia and polycystic ovarian syndrome, which can in turn increase fertility.

But physicians should also know how to manage an IVF cycle in an overweight patient who has not lost weight.

“We know that patients with high BMIs require higher doses of medications, particularly gonadotropins, to stimulate folliculogenesis, and they often require longer cycles,” Dr. Ryley said. “By increasing the doses of these medications, you can often get an adequate number of oocytes. However, in many of these patients, hormonal imbalances may have a deleterious effect on the quality of oocytes you get.”

PHILADELPHIA — Patients considering in vitro fertilization should be encouraged to aim for a healthy body mass index before they start treatment, results of a large retrospective study suggest.

“There was a trend toward decreasing success rates with increasing BMIs,” reported lead investigator David Ryley, M.D., of Beth Israel Deaconess Medical Center, Boston, and Boston IVF, a private fertility clinic.

The study reviewed more than 5,800 fresh, non-donor in vitro fertilization (IVF) cycles at Boston IVF in which the patient's BMI had been recorded, he reported at the annual meeting of the American Society for Reproductive Medicine.

Patients were divided into five groups according to BMI: under 20 kg/m

There was no difference between the groups with respect to the number of mature follicles, number of oocytes retrieved, number of mature oocytes, the number of cycles per patient, and the number of embryos transferred. Still, patients in the highest BMI category had a significantly lower implantation rate and clinical pregnancy rate, compared with the other BMI groups.

Although the clinical pregnancy rate ranged from about 27% to almost 33% in the lower BMI categories, it was not quite 22% in the highest BMI category.

Similarly, the implantation rate ranged from 18% to 20% in the lower BMI categories, but it was only 13% in the highest BMI category.

Unlike previous published studies on this topic, the current study did not find an association between extremely low BMI and poor IVF success rates, Dr. Ryley said.

“The best data in the literature suggest that severely low BMIs under 20, or under 18, affect the hypothalamic-pituitary axis, such that patients have irregular menstrual cycles and, therefore, have an impaired chance of fertility,” he told this newspaper. “But in our study the patients with the lowest BMIs actually had the highest pregnancy rates—although the difference was only significant when compared with the highest BMI category.”

The study's findings are consistent with other reports of how excess weight can impact hormonal balance and the quality of oocytes and embryos, he said. Weight loss can often correct problems such as hyperinsulinemia and polycystic ovarian syndrome, which can in turn increase fertility.

But physicians should also know how to manage an IVF cycle in an overweight patient who has not lost weight.

“We know that patients with high BMIs require higher doses of medications, particularly gonadotropins, to stimulate folliculogenesis, and they often require longer cycles,” Dr. Ryley said. “By increasing the doses of these medications, you can often get an adequate number of oocytes. However, in many of these patients, hormonal imbalances may have a deleterious effect on the quality of oocytes you get.”

ST. LOUIS — A unique approach to colpocleisis has been developed that incorporates vaginal repair of paravaginal defects, apposition of the pubocervical and rectovaginal septa, and minimal anatomical distortion.

“There is a place for this in your practice, and it is not hopelessly complicated,” Carl W. Zimmerman, M.D., said at the 14th International Pelvic Reconstructive and Vaginal Surgery Conference.

“We're relying on native endopelvic connective tissue to close the urogenital hiatus, which is unique in colpocleisis techniques,” said Dr. Zimmerman, professor of obstetrics and gynecology at Vanderbilt University, Nashville, Tenn.

The use of colpocleisis to correct advanced prolapse is certainly not for every woman, he stressed, since it permanently closes the vagina and therefore prevents coitus.

“This operation is not an option for the 11% of women with primary pelvic floor defects, or even for the 30% of patients who need a second corrective surgery. This is for the small percentage of physically active and relatively healthy individuals who have multiple recurrences or massive prolapse profoundly eroding their quality of life,” he said at the conference, sponsored by the Society of Pelvic Reconstructive Surgeons and Emory University.

Traditional colpocleisis closes the urogenital hiatus without specifically identifying the perivaginal endopelvic fascial septa, while using some degree of vaginectomy. This class of operation historically has been associated with failure because of the advanced degree of prolapse in the patients selected and the nonspecific operative technique, he added.

But Dr. Zimmerman has had no failures during 3 years of follow-up in the 15 patients he's treated using his site-specific technique.

“The unique part of this operation is that in other colpocleisis techniques the anterior and posterior vaginal walls are sutured together in a variety of ways, but there's no specific attempt to identify the fascial breaks and use those as a closure mechanism for the colpocleisis procedure,” he told this newspaper. This traditional approach results in a significant degree of anatomical distortion, which weakens the closure, Dr. Zimmerman explained.

With his site-specific technique, he said, “DeLancey level II lateral attachment is restored in the same way that it would be for a reconstruction, and the edges of the pubocervical and rectovaginal septa are then sutured together with permanent sutures. This technique occludes the urogenital hiatus in a site-specific fashion and eliminates vaginal depth. However, in the process, there is minimal anatomical disruption and maximal strength in the repair.”

This photo shows a patient with advanced pelvic organ prolapse.

This image shows the same patient after undergoing site-specific colpocleisis. Photos courtesy Dr. Carl W. Zimmerman

ST. LOUIS — A unique approach to colpocleisis has been developed that incorporates vaginal repair of paravaginal defects, apposition of the pubocervical and rectovaginal septa, and minimal anatomical distortion.

“There is a place for this in your practice, and it is not hopelessly complicated,” Carl W. Zimmerman, M.D., said at the 14th International Pelvic Reconstructive and Vaginal Surgery Conference.

“We're relying on native endopelvic connective tissue to close the urogenital hiatus, which is unique in colpocleisis techniques,” said Dr. Zimmerman, professor of obstetrics and gynecology at Vanderbilt University, Nashville, Tenn.

The use of colpocleisis to correct advanced prolapse is certainly not for every woman, he stressed, since it permanently closes the vagina and therefore prevents coitus.

“This operation is not an option for the 11% of women with primary pelvic floor defects, or even for the 30% of patients who need a second corrective surgery. This is for the small percentage of physically active and relatively healthy individuals who have multiple recurrences or massive prolapse profoundly eroding their quality of life,” he said at the conference, sponsored by the Society of Pelvic Reconstructive Surgeons and Emory University.

Traditional colpocleisis closes the urogenital hiatus without specifically identifying the perivaginal endopelvic fascial septa, while using some degree of vaginectomy. This class of operation historically has been associated with failure because of the advanced degree of prolapse in the patients selected and the nonspecific operative technique, he added.

But Dr. Zimmerman has had no failures during 3 years of follow-up in the 15 patients he's treated using his site-specific technique.

“The unique part of this operation is that in other colpocleisis techniques the anterior and posterior vaginal walls are sutured together in a variety of ways, but there's no specific attempt to identify the fascial breaks and use those as a closure mechanism for the colpocleisis procedure,” he told this newspaper. This traditional approach results in a significant degree of anatomical distortion, which weakens the closure, Dr. Zimmerman explained.

With his site-specific technique, he said, “DeLancey level II lateral attachment is restored in the same way that it would be for a reconstruction, and the edges of the pubocervical and rectovaginal septa are then sutured together with permanent sutures. This technique occludes the urogenital hiatus in a site-specific fashion and eliminates vaginal depth. However, in the process, there is minimal anatomical disruption and maximal strength in the repair.”

This photo shows a patient with advanced pelvic organ prolapse.

This image shows the same patient after undergoing site-specific colpocleisis. Photos courtesy Dr. Carl W. Zimmerman

ST. LOUIS — A unique approach to colpocleisis has been developed that incorporates vaginal repair of paravaginal defects, apposition of the pubocervical and rectovaginal septa, and minimal anatomical distortion.

“There is a place for this in your practice, and it is not hopelessly complicated,” Carl W. Zimmerman, M.D., said at the 14th International Pelvic Reconstructive and Vaginal Surgery Conference.

“We're relying on native endopelvic connective tissue to close the urogenital hiatus, which is unique in colpocleisis techniques,” said Dr. Zimmerman, professor of obstetrics and gynecology at Vanderbilt University, Nashville, Tenn.

The use of colpocleisis to correct advanced prolapse is certainly not for every woman, he stressed, since it permanently closes the vagina and therefore prevents coitus.

“This operation is not an option for the 11% of women with primary pelvic floor defects, or even for the 30% of patients who need a second corrective surgery. This is for the small percentage of physically active and relatively healthy individuals who have multiple recurrences or massive prolapse profoundly eroding their quality of life,” he said at the conference, sponsored by the Society of Pelvic Reconstructive Surgeons and Emory University.

Traditional colpocleisis closes the urogenital hiatus without specifically identifying the perivaginal endopelvic fascial septa, while using some degree of vaginectomy. This class of operation historically has been associated with failure because of the advanced degree of prolapse in the patients selected and the nonspecific operative technique, he added.

But Dr. Zimmerman has had no failures during 3 years of follow-up in the 15 patients he's treated using his site-specific technique.

“The unique part of this operation is that in other colpocleisis techniques the anterior and posterior vaginal walls are sutured together in a variety of ways, but there's no specific attempt to identify the fascial breaks and use those as a closure mechanism for the colpocleisis procedure,” he told this newspaper. This traditional approach results in a significant degree of anatomical distortion, which weakens the closure, Dr. Zimmerman explained.

With his site-specific technique, he said, “DeLancey level II lateral attachment is restored in the same way that it would be for a reconstruction, and the edges of the pubocervical and rectovaginal septa are then sutured together with permanent sutures. This technique occludes the urogenital hiatus in a site-specific fashion and eliminates vaginal depth. However, in the process, there is minimal anatomical disruption and maximal strength in the repair.”

This photo shows a patient with advanced pelvic organ prolapse.

This image shows the same patient after undergoing site-specific colpocleisis. Photos courtesy Dr. Carl W. Zimmerman

QUEBEC CITY — Noninvasive methods for identifying pediatric diabetic neuropathy are not as sensitive as conventional nerve conduction studies and should not be considered for screening purposes, Daniele Pacaud, M.D., said at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Her study compared vibration perception thresholds (VPT) and tactile perception thresholds (TPT) with nerve conduction studies (NCS) in 73 children, mean age 13 years, with type 1 diabetes.

For VPT testing, subjects were asked to touch a box with their big toe and to indicate if it is vibrating. The amplitude of the vibrations is steadily decreased until they become imperceptible.

For TPT, subjects were asked to indicate when they feel microfilaments that are applied to the plantar surface of the foot.

All children in the study completed a neurologic questionnaire, underwent NCS, and received a neurologic exam. Based on two abnormalities on NCS, diabetic neuropathy was present in 42 (57%) of the 73 subjects.

Of these, 37 were picked up by VPT, 26 by neurologic exam alone, and 19 by TPT, said Dr. Pacaud, of Alberta Children's Hospital and the University of Calgary in Calgary (Alta.). The neurologic symptoms questionnaire was not useful, she added.

QUEBEC CITY — Noninvasive methods for identifying pediatric diabetic neuropathy are not as sensitive as conventional nerve conduction studies and should not be considered for screening purposes, Daniele Pacaud, M.D., said at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Her study compared vibration perception thresholds (VPT) and tactile perception thresholds (TPT) with nerve conduction studies (NCS) in 73 children, mean age 13 years, with type 1 diabetes.

For VPT testing, subjects were asked to touch a box with their big toe and to indicate if it is vibrating. The amplitude of the vibrations is steadily decreased until they become imperceptible.

For TPT, subjects were asked to indicate when they feel microfilaments that are applied to the plantar surface of the foot.

All children in the study completed a neurologic questionnaire, underwent NCS, and received a neurologic exam. Based on two abnormalities on NCS, diabetic neuropathy was present in 42 (57%) of the 73 subjects.

Of these, 37 were picked up by VPT, 26 by neurologic exam alone, and 19 by TPT, said Dr. Pacaud, of Alberta Children's Hospital and the University of Calgary in Calgary (Alta.). The neurologic symptoms questionnaire was not useful, she added.

QUEBEC CITY — Noninvasive methods for identifying pediatric diabetic neuropathy are not as sensitive as conventional nerve conduction studies and should not be considered for screening purposes, Daniele Pacaud, M.D., said at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

Her study compared vibration perception thresholds (VPT) and tactile perception thresholds (TPT) with nerve conduction studies (NCS) in 73 children, mean age 13 years, with type 1 diabetes.

For VPT testing, subjects were asked to touch a box with their big toe and to indicate if it is vibrating. The amplitude of the vibrations is steadily decreased until they become imperceptible.

For TPT, subjects were asked to indicate when they feel microfilaments that are applied to the plantar surface of the foot.

All children in the study completed a neurologic questionnaire, underwent NCS, and received a neurologic exam. Based on two abnormalities on NCS, diabetic neuropathy was present in 42 (57%) of the 73 subjects.

Of these, 37 were picked up by VPT, 26 by neurologic exam alone, and 19 by TPT, said Dr. Pacaud, of Alberta Children's Hospital and the University of Calgary in Calgary (Alta.). The neurologic symptoms questionnaire was not useful, she added.

PHILADELPHIA — Egg and ovarian tissue freezing should not be marketed or offered to healthy women as a means to defer reproductive aging, according to a new report issued by the American Society for Reproductive Medicine.

Although the techniques hold promise for female fertility preservation, a lack of sufficient data on success rates and safety issues means these procedures should be performed only experimentally under Institutional Review Board guidelines and only in women who face potentially sterilizing treatment, the report states (Fertil. Steril. 2004;82:993-8).

Despite these recommendations, Extend Fertility, a Boston-based company that promotes egg freezing to healthy women as a means of extending their biological clocks, says it plans to continue offering the service through participating fertility clinics.

The company is offering the services under IRB guidelines; however, the cost is approximately $15,000 per cycle, and patients are usually advised to undertake several cycles, she said.

Bradford A. Kolb, M.D., of the Huntington Reproductive Center in Pasadena, Calif., one of the company's affiliated clinics, said, “We do recognize the controversy over this issue and do advise patients that this procedure should be considered experimental. It's not a guarantee of preserving one's future” fertility. Dr. Kolb also serves as a medical advisor to Extend Fertility.

Although there is no way to force clinics to follow the guidelines, ASRM spokesman Sean Tipton said that clinics that do not follow the guidelines risk losing their membership with the Society for Assisted Reproductive Technology (SART), an ASRM affiliate.

The cryopreservation techniques outlined in the report are “by no means ready for wide applications outside of investigational protocols,” Marc A. Fritz, M.D., chair of the ASRM practice committee that wrote the report, said during a press conference held at the meeting.

“It was the [ASRM's] view that the worldwide experience with these techniques is simply insufficient,” said Dr. Fritz, professor of ob.gyn. and chief of the reproductive endocrinology and infertility division at the University of North Carolina, Chapel Hill. He added that there have been fewer than 100 births from frozen eggs, although there have been no developmental or chromosomal abnormalities noted in any of these children. And although ovarian function has been restored in several cancer patients after ovarian tissue cryopreservation and transplantation, the first birth in a woman who underwent this procedure was announced only last September.

The ASRM report is less restrictive when it comes to patients who face potentially sterilizing chemotherapy or radiation therapy.

In this context, both oocyte and ovarian tissue cryopreservation techniques could be considered, the document states. In addition to cancer, this would include indications such as bone marrow or stem cell transplantation; oophorectomy for cancer prophylaxis or benign conditions; and certain autoimmune diseases.

In such cases, ovarian tissue freezing may be the only fertility-preserving option for women who do not have enough time to complete ovarian stimulation cycles before chemotherapy or radiation treatment. On the other hand, for women who do have time, egg freezing is less invasive than ovarian tissue freezing, and may be more attractive to women who do not currently have a male partner, the committee wrote.

The report also outlines safety issues concerning these techniques. In the case of ovarian tissue cryopreservation and subsequent transplantation in cancer patients, “there is a legitimate concern regarding the potential for reseeding tumor cells,” particularly when it comes to leukemias, neuroblastomas, and breast cancers. The document recommends that histological, immunohistochemical, and chromosomal evaluations should be performed on multiple harvested ovarian tissue samples before cryopreservation to minimize this risk.

There is also little known about the potential for malignant transformation of transplanted ovarian tissue. And in the case of oocyte cryopreservation, concerns remain regarding the effects of cryopreservation on the meiotic spindle of the oocyte and the potential for chromosomal aneuploidy or other karyotypic abnormalities in the offspring, according to the report.

PHILADELPHIA — Egg and ovarian tissue freezing should not be marketed or offered to healthy women as a means to defer reproductive aging, according to a new report issued by the American Society for Reproductive Medicine.

Although the techniques hold promise for female fertility preservation, a lack of sufficient data on success rates and safety issues means these procedures should be performed only experimentally under Institutional Review Board guidelines and only in women who face potentially sterilizing treatment, the report states (Fertil. Steril. 2004;82:993-8).

Despite these recommendations, Extend Fertility, a Boston-based company that promotes egg freezing to healthy women as a means of extending their biological clocks, says it plans to continue offering the service through participating fertility clinics.

The company is offering the services under IRB guidelines; however, the cost is approximately $15,000 per cycle, and patients are usually advised to undertake several cycles, she said.

Bradford A. Kolb, M.D., of the Huntington Reproductive Center in Pasadena, Calif., one of the company's affiliated clinics, said, “We do recognize the controversy over this issue and do advise patients that this procedure should be considered experimental. It's not a guarantee of preserving one's future” fertility. Dr. Kolb also serves as a medical advisor to Extend Fertility.

Although there is no way to force clinics to follow the guidelines, ASRM spokesman Sean Tipton said that clinics that do not follow the guidelines risk losing their membership with the Society for Assisted Reproductive Technology (SART), an ASRM affiliate.

The cryopreservation techniques outlined in the report are “by no means ready for wide applications outside of investigational protocols,” Marc A. Fritz, M.D., chair of the ASRM practice committee that wrote the report, said during a press conference held at the meeting.

“It was the [ASRM's] view that the worldwide experience with these techniques is simply insufficient,” said Dr. Fritz, professor of ob.gyn. and chief of the reproductive endocrinology and infertility division at the University of North Carolina, Chapel Hill. He added that there have been fewer than 100 births from frozen eggs, although there have been no developmental or chromosomal abnormalities noted in any of these children. And although ovarian function has been restored in several cancer patients after ovarian tissue cryopreservation and transplantation, the first birth in a woman who underwent this procedure was announced only last September.

The ASRM report is less restrictive when it comes to patients who face potentially sterilizing chemotherapy or radiation therapy.

In this context, both oocyte and ovarian tissue cryopreservation techniques could be considered, the document states. In addition to cancer, this would include indications such as bone marrow or stem cell transplantation; oophorectomy for cancer prophylaxis or benign conditions; and certain autoimmune diseases.

In such cases, ovarian tissue freezing may be the only fertility-preserving option for women who do not have enough time to complete ovarian stimulation cycles before chemotherapy or radiation treatment. On the other hand, for women who do have time, egg freezing is less invasive than ovarian tissue freezing, and may be more attractive to women who do not currently have a male partner, the committee wrote.

The report also outlines safety issues concerning these techniques. In the case of ovarian tissue cryopreservation and subsequent transplantation in cancer patients, “there is a legitimate concern regarding the potential for reseeding tumor cells,” particularly when it comes to leukemias, neuroblastomas, and breast cancers. The document recommends that histological, immunohistochemical, and chromosomal evaluations should be performed on multiple harvested ovarian tissue samples before cryopreservation to minimize this risk.

There is also little known about the potential for malignant transformation of transplanted ovarian tissue. And in the case of oocyte cryopreservation, concerns remain regarding the effects of cryopreservation on the meiotic spindle of the oocyte and the potential for chromosomal aneuploidy or other karyotypic abnormalities in the offspring, according to the report.

PHILADELPHIA — Egg and ovarian tissue freezing should not be marketed or offered to healthy women as a means to defer reproductive aging, according to a new report issued by the American Society for Reproductive Medicine.

Although the techniques hold promise for female fertility preservation, a lack of sufficient data on success rates and safety issues means these procedures should be performed only experimentally under Institutional Review Board guidelines and only in women who face potentially sterilizing treatment, the report states (Fertil. Steril. 2004;82:993-8).

Despite these recommendations, Extend Fertility, a Boston-based company that promotes egg freezing to healthy women as a means of extending their biological clocks, says it plans to continue offering the service through participating fertility clinics.

The company is offering the services under IRB guidelines; however, the cost is approximately $15,000 per cycle, and patients are usually advised to undertake several cycles, she said.

Bradford A. Kolb, M.D., of the Huntington Reproductive Center in Pasadena, Calif., one of the company's affiliated clinics, said, “We do recognize the controversy over this issue and do advise patients that this procedure should be considered experimental. It's not a guarantee of preserving one's future” fertility. Dr. Kolb also serves as a medical advisor to Extend Fertility.

Although there is no way to force clinics to follow the guidelines, ASRM spokesman Sean Tipton said that clinics that do not follow the guidelines risk losing their membership with the Society for Assisted Reproductive Technology (SART), an ASRM affiliate.

The cryopreservation techniques outlined in the report are “by no means ready for wide applications outside of investigational protocols,” Marc A. Fritz, M.D., chair of the ASRM practice committee that wrote the report, said during a press conference held at the meeting.

“It was the [ASRM's] view that the worldwide experience with these techniques is simply insufficient,” said Dr. Fritz, professor of ob.gyn. and chief of the reproductive endocrinology and infertility division at the University of North Carolina, Chapel Hill. He added that there have been fewer than 100 births from frozen eggs, although there have been no developmental or chromosomal abnormalities noted in any of these children. And although ovarian function has been restored in several cancer patients after ovarian tissue cryopreservation and transplantation, the first birth in a woman who underwent this procedure was announced only last September.

The ASRM report is less restrictive when it comes to patients who face potentially sterilizing chemotherapy or radiation therapy.

In this context, both oocyte and ovarian tissue cryopreservation techniques could be considered, the document states. In addition to cancer, this would include indications such as bone marrow or stem cell transplantation; oophorectomy for cancer prophylaxis or benign conditions; and certain autoimmune diseases.

In such cases, ovarian tissue freezing may be the only fertility-preserving option for women who do not have enough time to complete ovarian stimulation cycles before chemotherapy or radiation treatment. On the other hand, for women who do have time, egg freezing is less invasive than ovarian tissue freezing, and may be more attractive to women who do not currently have a male partner, the committee wrote.

The report also outlines safety issues concerning these techniques. In the case of ovarian tissue cryopreservation and subsequent transplantation in cancer patients, “there is a legitimate concern regarding the potential for reseeding tumor cells,” particularly when it comes to leukemias, neuroblastomas, and breast cancers. The document recommends that histological, immunohistochemical, and chromosomal evaluations should be performed on multiple harvested ovarian tissue samples before cryopreservation to minimize this risk.

There is also little known about the potential for malignant transformation of transplanted ovarian tissue. And in the case of oocyte cryopreservation, concerns remain regarding the effects of cryopreservation on the meiotic spindle of the oocyte and the potential for chromosomal aneuploidy or other karyotypic abnormalities in the offspring, according to the report.

PHILADELPHIA — Results of two new U.S. studies may help dispel fears that single blastocyst transfer results in poor pregnancy success rates. The studies were presented at the annual meeting of the American Society for Reproductive Medicine.

Single blastocyst transfer, which is widely practiced in Europe, guarantees a reduction in multiple births, the biggest problem facing fertility specialists worldwide.

Although triplet pregnancies have been reduced dramatically in the United States by limiting the number of embryos transferred, twin pregnancies still make up roughly one-third of all births from assisted reproductive technology (ART). The most recent figures from the Centers for Disease Control and Prevention show that in 2001 64% of ART births were singletons, 32% were twins, and almost 4% were triplets or other higher order multiples. More than three embryos were transferred in roughly 66% of the ART cycles.

Despite recently released guidelines from the American Society for Reproductive Medicine (ASRM), which suggest consideration of single embryo transfer in patients with the most favorable prognosis (Fertil. Steril. 2004;82:773-4), there has been considerable resistance to this practice in the United States. Many physicians and patients fear that single embryo transfer may reduce overall pregnancy rates. The failure of an in vitro fertilization (IVF) cycle is a financial burden that rests almost entirely on U.S. patients' shoulders. In contrast, the cost of IVF is covered by the national health care systems of most European countries.

Results of the two studies presented at the meeting may help change some people's opinion about the practice. “We feel strongly that single blastocyst transfer is the way to go,” said Marius Meintjes, Ph.D., scientific director of assisted reproductive technology services at Presbyterian Hospital of Dallas.

He presented a 3-year retrospective study that examined live birth rates and twinning rates among 103 patients who had single blastocyst transfer (SBT) and 290 who had double blastocyst transfer (DBT). To be eligible for SBT, patients had to be 37 years of age or younger or be receiving donated oocytes. Patients had to have at least two excellent quality embryos to choose from on the day of transfer. The excess embryos were frozen, and if the patient failed to become pregnant during the fresh cycle, the clinic agreed to pay for subsequent frozen embryo cycles free of charge.

The SBT group had a slightly higher rate of live births/ongoing pregnancies in the fresh cycle, compared with the DBT group (79% vs. 70·9%). But the cumulative rate, which included both fresh and frozen cycles, was not significantly different between groups (79·6% vs. 83·4%). In contrast, the rate of twins was significantly less in the SBT group (2% vs. 68%). There was one case of monozygotic twinning in the SBT group. These results are an important contribution toward convincing patients and physicians that SBT won't decrease the chance of pregnancy, but will reduce the risk of twins. “Patient education is also critical, because there is too much of a perception that twins are OK. This is probably our biggest challenge,” said Dr. Meintjes, adding that the clinic's offer to cover the extra costs of undergoing a frozen cycle removed a financial barrier to SBT.

Roughly one-third of patients who were offered SBT accepted, and almost half of the DBT group had no option for SBT because they didn't have a second good quality blastocyst for freezing.

Another retrospective study had similar findings. Amy R. Criniti, M.D., of the University of Washington, Seattle, and her colleagues compared good prognosis IVF cycles in which one blastocyst (44 cycles) or two blastocysts (66 cycles) were transferred.

Although pregnancy rates in the fresh cycle were slightly higher in the DBT group (79% vs. 76%), when the results from frozen cycles were included, the cumulative pregnancy rate was 83% in both groups. Once again, the SBT group had a significantly smaller percentage of twin pregnancies (3% vs. 62%). There was one case of monozygotic twinning in the SBT.

Eligibility for SBT included age less than 38 years, no previous failure of an IVF cycle, no endometriosis, a normal endometrium at the time of HCG administration, a normal uterine cavity, and at least three blastocysts available on the day of transfer, Dr. Criniti said.

In the United States there has been considerable resistance to transferring only one embryo during an IVF cycle. Courtesy Marisu Meintjes, Ph.D.

PHILADELPHIA — Results of two new U.S. studies may help dispel fears that single blastocyst transfer results in poor pregnancy success rates. The studies were presented at the annual meeting of the American Society for Reproductive Medicine.

Single blastocyst transfer, which is widely practiced in Europe, guarantees a reduction in multiple births, the biggest problem facing fertility specialists worldwide.

Although triplet pregnancies have been reduced dramatically in the United States by limiting the number of embryos transferred, twin pregnancies still make up roughly one-third of all births from assisted reproductive technology (ART). The most recent figures from the Centers for Disease Control and Prevention show that in 2001 64% of ART births were singletons, 32% were twins, and almost 4% were triplets or other higher order multiples. More than three embryos were transferred in roughly 66% of the ART cycles.

Despite recently released guidelines from the American Society for Reproductive Medicine (ASRM), which suggest consideration of single embryo transfer in patients with the most favorable prognosis (Fertil. Steril. 2004;82:773-4), there has been considerable resistance to this practice in the United States. Many physicians and patients fear that single embryo transfer may reduce overall pregnancy rates. The failure of an in vitro fertilization (IVF) cycle is a financial burden that rests almost entirely on U.S. patients' shoulders. In contrast, the cost of IVF is covered by the national health care systems of most European countries.

Results of the two studies presented at the meeting may help change some people's opinion about the practice. “We feel strongly that single blastocyst transfer is the way to go,” said Marius Meintjes, Ph.D., scientific director of assisted reproductive technology services at Presbyterian Hospital of Dallas.

He presented a 3-year retrospective study that examined live birth rates and twinning rates among 103 patients who had single blastocyst transfer (SBT) and 290 who had double blastocyst transfer (DBT). To be eligible for SBT, patients had to be 37 years of age or younger or be receiving donated oocytes. Patients had to have at least two excellent quality embryos to choose from on the day of transfer. The excess embryos were frozen, and if the patient failed to become pregnant during the fresh cycle, the clinic agreed to pay for subsequent frozen embryo cycles free of charge.

The SBT group had a slightly higher rate of live births/ongoing pregnancies in the fresh cycle, compared with the DBT group (79% vs. 70·9%). But the cumulative rate, which included both fresh and frozen cycles, was not significantly different between groups (79·6% vs. 83·4%). In contrast, the rate of twins was significantly less in the SBT group (2% vs. 68%). There was one case of monozygotic twinning in the SBT group. These results are an important contribution toward convincing patients and physicians that SBT won't decrease the chance of pregnancy, but will reduce the risk of twins. “Patient education is also critical, because there is too much of a perception that twins are OK. This is probably our biggest challenge,” said Dr. Meintjes, adding that the clinic's offer to cover the extra costs of undergoing a frozen cycle removed a financial barrier to SBT.

Roughly one-third of patients who were offered SBT accepted, and almost half of the DBT group had no option for SBT because they didn't have a second good quality blastocyst for freezing.

Another retrospective study had similar findings. Amy R. Criniti, M.D., of the University of Washington, Seattle, and her colleagues compared good prognosis IVF cycles in which one blastocyst (44 cycles) or two blastocysts (66 cycles) were transferred.

Although pregnancy rates in the fresh cycle were slightly higher in the DBT group (79% vs. 76%), when the results from frozen cycles were included, the cumulative pregnancy rate was 83% in both groups. Once again, the SBT group had a significantly smaller percentage of twin pregnancies (3% vs. 62%). There was one case of monozygotic twinning in the SBT.

Eligibility for SBT included age less than 38 years, no previous failure of an IVF cycle, no endometriosis, a normal endometrium at the time of HCG administration, a normal uterine cavity, and at least three blastocysts available on the day of transfer, Dr. Criniti said.

In the United States there has been considerable resistance to transferring only one embryo during an IVF cycle. Courtesy Marisu Meintjes, Ph.D.

PHILADELPHIA — Results of two new U.S. studies may help dispel fears that single blastocyst transfer results in poor pregnancy success rates. The studies were presented at the annual meeting of the American Society for Reproductive Medicine.

Single blastocyst transfer, which is widely practiced in Europe, guarantees a reduction in multiple births, the biggest problem facing fertility specialists worldwide.

Although triplet pregnancies have been reduced dramatically in the United States by limiting the number of embryos transferred, twin pregnancies still make up roughly one-third of all births from assisted reproductive technology (ART). The most recent figures from the Centers for Disease Control and Prevention show that in 2001 64% of ART births were singletons, 32% were twins, and almost 4% were triplets or other higher order multiples. More than three embryos were transferred in roughly 66% of the ART cycles.

Despite recently released guidelines from the American Society for Reproductive Medicine (ASRM), which suggest consideration of single embryo transfer in patients with the most favorable prognosis (Fertil. Steril. 2004;82:773-4), there has been considerable resistance to this practice in the United States. Many physicians and patients fear that single embryo transfer may reduce overall pregnancy rates. The failure of an in vitro fertilization (IVF) cycle is a financial burden that rests almost entirely on U.S. patients' shoulders. In contrast, the cost of IVF is covered by the national health care systems of most European countries.

Results of the two studies presented at the meeting may help change some people's opinion about the practice. “We feel strongly that single blastocyst transfer is the way to go,” said Marius Meintjes, Ph.D., scientific director of assisted reproductive technology services at Presbyterian Hospital of Dallas.

He presented a 3-year retrospective study that examined live birth rates and twinning rates among 103 patients who had single blastocyst transfer (SBT) and 290 who had double blastocyst transfer (DBT). To be eligible for SBT, patients had to be 37 years of age or younger or be receiving donated oocytes. Patients had to have at least two excellent quality embryos to choose from on the day of transfer. The excess embryos were frozen, and if the patient failed to become pregnant during the fresh cycle, the clinic agreed to pay for subsequent frozen embryo cycles free of charge.

The SBT group had a slightly higher rate of live births/ongoing pregnancies in the fresh cycle, compared with the DBT group (79% vs. 70·9%). But the cumulative rate, which included both fresh and frozen cycles, was not significantly different between groups (79·6% vs. 83·4%). In contrast, the rate of twins was significantly less in the SBT group (2% vs. 68%). There was one case of monozygotic twinning in the SBT group. These results are an important contribution toward convincing patients and physicians that SBT won't decrease the chance of pregnancy, but will reduce the risk of twins. “Patient education is also critical, because there is too much of a perception that twins are OK. This is probably our biggest challenge,” said Dr. Meintjes, adding that the clinic's offer to cover the extra costs of undergoing a frozen cycle removed a financial barrier to SBT.

Roughly one-third of patients who were offered SBT accepted, and almost half of the DBT group had no option for SBT because they didn't have a second good quality blastocyst for freezing.

Another retrospective study had similar findings. Amy R. Criniti, M.D., of the University of Washington, Seattle, and her colleagues compared good prognosis IVF cycles in which one blastocyst (44 cycles) or two blastocysts (66 cycles) were transferred.

Although pregnancy rates in the fresh cycle were slightly higher in the DBT group (79% vs. 76%), when the results from frozen cycles were included, the cumulative pregnancy rate was 83% in both groups. Once again, the SBT group had a significantly smaller percentage of twin pregnancies (3% vs. 62%). There was one case of monozygotic twinning in the SBT.

Eligibility for SBT included age less than 38 years, no previous failure of an IVF cycle, no endometriosis, a normal endometrium at the time of HCG administration, a normal uterine cavity, and at least three blastocysts available on the day of transfer, Dr. Criniti said.

In the United States there has been considerable resistance to transferring only one embryo during an IVF cycle. Courtesy Marisu Meintjes, Ph.D.

MONT-TREMBLANT, QUE. — A new treatment algorithm for the ThermaCool radiofrequency energy device is producing improved cosmetic results with a reduction in pain and adverse events, Michael Kaminer, M.D., said at a symposium on cutaneous laser surgery sponsored by SkinCare Physicians of Chestnut Hill.

"A year ago we were doing most treatments with one single pass over the face and trying to use as high an energy setting on the machine as our patients could tolerate. The concept was, since we're only going to go over the face once, we should give it as much heat as we could. But it hurt the patients a lot, and it wasn't working that well, so out of necessity we had to rethink this strategy."

Dr. Kaminer, a dermatologist with SkinCare Physicians of Chestnut Hill, Mass., said that he and some of his colleagues discovered the value of performing multiple passes with lower fluences when using ThermaCool (Thermage Inc.). He explained that in the past, roughly 70% of patients had marginal and variable results or did not respond to treatment at all, but the numbers have reversed with the new treatment algorithm; 70% now show good results.

"I call it the Thermage treatment triad—which includes controlling the pain, increasing the number of passes, and lowering the setting on the machine," he said.

With adequate pain control, including a topical anesthetic (LMX 5% lidocaine cream), oral lorazepam (Ativan) 1 mg about an hour beforehand, and then an injection of meperidine (Demerol) about 15 minutes prior to the procedure, Dr. Kaminer said patients can tolerate multiple passes over the face, at a lower setting.

"So we have rapidly moved from one high-energy pass to as many as six and seven passes at very low settings. With the company's new big fast tip, which is a 1.5-cm tip, where we used to use settings ranging from 64 to 65, we now use settings ranging from 62 to 64. And with the older 1-cm tip, where we used to use settings of 75 and 76, we now use settings between 72 and 74," he said.

The added advantage of this approach is that physicians can monitor the effects of the treatment during the procedure.

Dr. Kaminer disclosed that he serves on the board for Thermage.

MONT-TREMBLANT, QUE. — A new treatment algorithm for the ThermaCool radiofrequency energy device is producing improved cosmetic results with a reduction in pain and adverse events, Michael Kaminer, M.D., said at a symposium on cutaneous laser surgery sponsored by SkinCare Physicians of Chestnut Hill.

"A year ago we were doing most treatments with one single pass over the face and trying to use as high an energy setting on the machine as our patients could tolerate. The concept was, since we're only going to go over the face once, we should give it as much heat as we could. But it hurt the patients a lot, and it wasn't working that well, so out of necessity we had to rethink this strategy."

Dr. Kaminer, a dermatologist with SkinCare Physicians of Chestnut Hill, Mass., said that he and some of his colleagues discovered the value of performing multiple passes with lower fluences when using ThermaCool (Thermage Inc.). He explained that in the past, roughly 70% of patients had marginal and variable results or did not respond to treatment at all, but the numbers have reversed with the new treatment algorithm; 70% now show good results.

"I call it the Thermage treatment triad—which includes controlling the pain, increasing the number of passes, and lowering the setting on the machine," he said.

With adequate pain control, including a topical anesthetic (LMX 5% lidocaine cream), oral lorazepam (Ativan) 1 mg about an hour beforehand, and then an injection of meperidine (Demerol) about 15 minutes prior to the procedure, Dr. Kaminer said patients can tolerate multiple passes over the face, at a lower setting.

"So we have rapidly moved from one high-energy pass to as many as six and seven passes at very low settings. With the company's new big fast tip, which is a 1.5-cm tip, where we used to use settings ranging from 64 to 65, we now use settings ranging from 62 to 64. And with the older 1-cm tip, where we used to use settings of 75 and 76, we now use settings between 72 and 74," he said.

The added advantage of this approach is that physicians can monitor the effects of the treatment during the procedure.

Dr. Kaminer disclosed that he serves on the board for Thermage.

MONT-TREMBLANT, QUE. — A new treatment algorithm for the ThermaCool radiofrequency energy device is producing improved cosmetic results with a reduction in pain and adverse events, Michael Kaminer, M.D., said at a symposium on cutaneous laser surgery sponsored by SkinCare Physicians of Chestnut Hill.

"A year ago we were doing most treatments with one single pass over the face and trying to use as high an energy setting on the machine as our patients could tolerate. The concept was, since we're only going to go over the face once, we should give it as much heat as we could. But it hurt the patients a lot, and it wasn't working that well, so out of necessity we had to rethink this strategy."

Dr. Kaminer, a dermatologist with SkinCare Physicians of Chestnut Hill, Mass., said that he and some of his colleagues discovered the value of performing multiple passes with lower fluences when using ThermaCool (Thermage Inc.). He explained that in the past, roughly 70% of patients had marginal and variable results or did not respond to treatment at all, but the numbers have reversed with the new treatment algorithm; 70% now show good results.

"I call it the Thermage treatment triad—which includes controlling the pain, increasing the number of passes, and lowering the setting on the machine," he said.

With adequate pain control, including a topical anesthetic (LMX 5% lidocaine cream), oral lorazepam (Ativan) 1 mg about an hour beforehand, and then an injection of meperidine (Demerol) about 15 minutes prior to the procedure, Dr. Kaminer said patients can tolerate multiple passes over the face, at a lower setting.

"So we have rapidly moved from one high-energy pass to as many as six and seven passes at very low settings. With the company's new big fast tip, which is a 1.5-cm tip, where we used to use settings ranging from 64 to 65, we now use settings ranging from 62 to 64. And with the older 1-cm tip, where we used to use settings of 75 and 76, we now use settings between 72 and 74," he said.

The added advantage of this approach is that physicians can monitor the effects of the treatment during the procedure.

Dr. Kaminer disclosed that he serves on the board for Thermage.