The Octuplet Pregnancy

The recent birth of an octuplet pregnancy, reportedly from the transfer of six embryos into a young woman has raised serious questions about the practices of fertility centers. The Yale Fertility Center has never practiced in such a cavalier and dangerous fashion. The serious consequences of high order multiple gestation guarantee significant impairment in the children born from these pregnancies. Moreover most will not even survive. The American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) have longstanding guidelines that govern the appropriate number of embryos to transfer under normal circumstances. These rules were clearly violated in the recent case in California.

One way for the public to asses the quality and safety of an infertility practice is thorough examination of SART data. This is publicly available through the SART web site and from the Centers for Disease Control and Prevention (CDC). Pregnancy rate per cycle can be assessed as well as the number of multiple gestation pregnancies. While there is no category for octuplets on the SART form (as this may never have happened previously), the number of twins and triplets can be identified. Another telling figure is the average number of embryos transferred. SART specifies that this should be no more than two in young women with high quality embryos. While this number may reasonably be higher when age, embryo quality or prior failures are taken into account, it should be well under three on average. In the case of the octuplets these numbers suggest a practice that is well outside of the SART recommendations. In that California practice the average pregnancy rate was low and the number of embryos transferred was shockingly high.

As Clinical Director of SART, I can assure you that action is being taken to prevent future occurrences of higher order multiples. We do not want this episode to tarnish the reputation of the vast majority of our member clinics that practice responsible medicine. This case has highlighted the need to improve the quality assurance processes that SART has in place. We will be more vigilant in identifying unsafe situations in order to prevent these types of negative outcomes.

Starting with the most recent data released earlier this month, SART will identify outlier programs that are consistently not compliant with embryo transfer guidelines and have high order multiple pregnancies. SART will identify all cycles in which the number of embryos transferred in young patients exceed guidelines and will require an explanation for the guideline deviation. Programs that have consistently poor pregnancy outcomes will be offered assistance from SART to help them improve. If they do not respond or fail to demonstrate a real effort to reduce the number of embryos transferred, SART membership will be revoked.

At Yale we have a high pregnancy rate, the only program in our state to have a greater than 50% pregnancy rate in any age group. We do this with an average number of embryos transferred that is well less than three. I can assure you that patients at Yale are receiving high quality and safe IVF treatment from leaders in the field.

Vitamin D: Sunlight Can Be Good for You

Evidence is growing that Vitamin D is crucial to many aspects of health—and that deficiency is extremely common, even in seemingly healthy people. The vitamin’s best-known role is in building bone, but low levels also appear to be associated with diabetes, heart disease, and infertility, among other diseases. “When you start looking at the data, the health benefits of D appear to be at every cellular level, in multiple organs,” said Lubna Pal, M.B.B.S., director of the Reproductive Aging and Bone Health Program.

Pal and her colleagues studied the health records of over 400 healthy pre-menopausal women and found that an astonishing 79% of them had low vitamin D levels. She found a link between low vitamin D levels and abnormal levels of blood sugar, insulin, inflammatory markers, and body mass. Such markers are associated with a higher risk of cardiovascular disease and diabetes. Women who were not Caucasian had lower levels of vitamin D, while more physically active women had higher levels.

In a previous study, Pal checked levels of vitamin D in the ovaries of 84 women undergoing fertility treatments. Almost two-thirds of the women had low levels, and those who achieved pregnancy had, on the average, higher levels of vitamin D than those who didn’t.

Vitamin D is made by the skin when touched by sunlight; it is also found in some foods. “We’re becoming more under-the-shade workers [and are] not getting our daily allowance,” said Pal. She suggests spending 10 minutes in the sun each day.

PCOS in Adolescents

Signs and symptoms of Polycystic Ovarian Syndrome (PCOS) can be seen during a girl’s pubertal transition. Although the normal pubertal course involves irregular menstrual cycles, increased androgen production, and increased body mass and insulin resistance, these processes are often exaggerated in girls with PCOS. A delay of greater than two years between the onset of puberty and the occurrence of menses may indicate PCOS. Furthermore, one early sign of PCOS may be the early appearance of pubic hair in young girls, prior to puberty. Adolescents with PCOS can present with a variety of symptoms which tend to start gradually, and can include irregular menstrual cycles, heavy uterine bleeding, acne, depression, weight gain, unwanted hair growth, or scalp hair loss.

One of the hallmarks of PCOS is irregular menstrual cycles. While it is normal for a young woman to experience irregular menstrual cycles for the first 6 to 12 months after her first menses, it is abnormal if the irregularity persists beyond 12 months. These young women deserve evaluation to determine a cause of their irregular cycles. In the past, young women were often prescribed oral contraceptives (birth control pills) to regulate their menstrual cycle, without any evaluation. However, due to the long-term health risks associated with PCOS, the ability to make this diagnosis in adolescents will hopefully improve the long-term health of these young women.

Similar to adult women, medical therapies for adolescents with PCOS include birth control pills, insulin sensitizing agents, and anti-androgen treatments. Treatment is individualized to the needs of each patient, and is tailored to where she is in her pubertal course.

Yale PCOS Program: A “One-Stop Shop” for Women with PCOS

Because Polycystic Ovarian Syndrome (PCOS) affects more than just the ovaries, Yale experts are teaming up to form a PCOS center for excellence. Clinicians at the Yale Program for PCOS will not only treat PCOS but also address problems that may accompany this diagnosis including fertility problems, body weight and body image issues, high cholesterol, insulin resistance and risk for diabetes, high blood pressure and risk for heart disease. The result will be what Dr. Pinar Kodaman, calls a “more holistic approach.”

“Beyond improving the overall health of women with PCOS, our goals are to help the patients take charge of PCOS,” says Dr. Lubna Pal, director of the Yale PCOS Program. During a single convenient appointment, patients will undergo evaluation by our team of expert physicians and nutritionists. Management strategies will be individualized to the needs of each patient. Risk profiles for heart disease and diabetes will be determined through detailed assessments, including tests that reflect the most advanced research into the disorder. Health goals will be identified (target weight, cholesterol, blood pressure, blood sugar, vitamin D level) and our team will work with each patient to ensure that these goals are met.

Each of the Yale Ob/Gyn physicians at the Yale PCOS Program brings her own expertise to the table:
Adolescents and teenagers with symptoms of PCOS (such as menstrual irregularities, excessive facial and body hair and acne) will benefit from Dr. Beth Rackow’s expertise in adolescent gynecology and menstrual disorders.

Utilizing combinations of lifestyle modifications and medications, Dr. Kodaman will focus on reducing risks for cardiovascular disease while Dr. Pal concentrates on issues of insulin resistance and diabetes.

Dr. Stephen Thung, a Yale Maternal-Fetal Medicine specialist with a special interest in the management of gestational diabetes and hypertension in pregnancy (common in women with PCOS), joins the team as a resource for preconception consultation for patients deemed at high risk for pregnancy-related problems.

Amy Krystock, a registered dietitian, employs a total lifestyle modification approach, utilizing customized diet and exercise programs for women with PCOS.

Dorothy Greenfeld, LCSW, provides an invaluable resource for psychological support, helping patients overcome the stress of PCOS symptoms and diagnosis.

By combining our efforts and expertise, we hope to be able to address the health needs of women of all ages diagnosed with PCOS. “I can foresee a teenager with PCOS being cared for at our center through her reproductive years into menopause,” says Dr. Pal.