Monday, April 13, 2009

The Egg Donation Process


Once a woman has been accepted as an egg donor, she will take a series of fertility drugs (some of which must be injected) to stimulate her ovaries to produce many eggs at one time. While using the drugs, she will be scheduled for several medical tests (blood tests and ultrasounds), and after her eggs have matured they will be removed using a needle and ultrasound probe. The eggs will be fertilized with sperm from the intended father or a sperm donor in our state of the art embryology laboratory and will incubate for two to five days. A number of the fertilized embryos will then be transferred to the recipient’s uterus and a pregnancy test will be performed 9 to 12 days after the transfer.

Becoming an Egg Donor

Becoming an egg donor means that you are giving another woman the opportunity to achieve pregnancy, experience childbirth, and realize her dream of building a family. Egg donation can be the answer for women who have unsuccessfully tried other infertility procedures or for women who were born without ovaries, whose ovaries have been removed, or whose ovaries may have been may have been damaged by radiation or chemotherapy.

Donors may be anonymous or they may be known. Anonymous donors are recruited from local communities, are carefully screened, and their identities remain anonymous throughout the entire donor process. Known donors may be a family member, relative, or friend of the recipient.

Monday, April 6, 2009

Making the Right Choices When it Comes to Multiples

Pasquale Patrizio
The recent birth of octuplets to a California woman receiving infertility treatment has raised questions about the practices used by infertility doctors. Dr. Pasquale Patrizio, director of the Yale Fertility Center, discusses the safeguards in place to ensure that nothing similar happens here.

Q. What is your reaction when you hear a story like the one about the woman in California giving birth to octuplets?

A. I am not happy. High order multiple births (triplets or more) resulting from in vitro fertilization (IVF) are considered medical failures. Besides the known pregnancy complications of multiple births—preterm labor and the many health concerns related to premature delivery—there is also the issue of how are you going to raise these children. If someone comes to me and already has six children, like in this particular case, I have a duty to refer this patient to social service. If she’s asking me to transfer eight embryos, something is not right.

Q. IVF treatments can cost $10,000 a piece. What do you do if a patient comes to you and says, “I don’t’ have a lot of money for IVF treatments. Could you please implant as many embryos as possible to improve my chances of getting pregnant on the first try?”

A. We have to follow the guidelines developed by the American Society of Reproductive Medicine. It’s simply not okay to transfer six or seven embryos into a woman who is younger than 35 and has a good prognosis for a successful pregnancy. So, it doesn’t matter if the woman requests that I implant all the embryos. I’m not going to honor that request.

Q. What are the guidelines?

A. For a woman younger than 35 with a good prognosis, the guidelines say one embryo if the transfer is performed on day five after egg retrieval, with a maximum of two if the transfer is performed on day three. The older the woman, the more embryos we’re allowed to transfer. At 40, you can transfer three or four tops. For patients 42 or older, you can transfer up to 5. If someone goes beyond this, you really need a valid justification, and it’s very, very rare.

Q. But these are just guidelines, right? They’re not mandatory?

A. Right. We voluntarily file annual clinic summary reports with the Society of Assisted Reproductive Technologies (SART). The reporting rate is about 95 percent, so we’re doing a pretty good job of making our data available for public scrutiny and information.

Q. What do you report?

A. The age of the woman, the number of cycles started, the number of retrievals, the average number of embryos transferred by age group, the number of pregnancies, the number of deliveries, the number of multiple births and the number canceled cycles. Centers can also be audited, which is one way we protect citizens from cheaters. If a center makes up numbers and is caught, there can be sanctions.

Q. Would there be less pressure from patients to implant multiple embryos if insurance for infertility treatment were better?

A. It’s possible. In Belgium and some other European countries, insurance pays for treatment, and insurers tell you how many embryos you can implant. In the United States only 15 out of the 50 states [including Connecticut] mandate insurance coverage for infertility. Somebody should do a study on whether states that cover infertility have fewer multiple births than states that don’t.

Q. Does competition among centers add to the temptation to implant more embryos to keep the pregnancy success rate high?

A. There’s definitely pressure on centers to compete, and patients do their homework about clinic success rates. There are 425 fertility clinics in the United States, but the number of cycles of IVF has flattened, because the baby boomer generation is now older.

Q. Is the number of high order multiple births going down?

A. The number is indeed going down. The number of triplets is now around 2 percent. A few years ago it was 3.5 to 4 percent, and in 1996 it was 7 percent. The average number of embryo transfers has been decreasing, too, from an average of four in 1996 to 2.6 now.

Q. What about selective reduction (targeting one or more fetuses in a multifetal pregnancy for termination) as a way of avoiding multiple births?

A. We try not to go there, but since women are very well-informed about infertility treatments and procedures, sometimes they ask you, “Please implant three embryos. If they all survive, I’ll have a selective reduction.” I’m personally not very comfortable with this concept. I only want to use it as a last, last, last resort.

Q. Does an incident like the California octuplets undermine the credibility of your field?

A. Yes, of course. You see how much ink has been spent on this issue, and it makes us, as a professional group, look bad. There is so much hard work by a team of professionals behind the scenes to help couples achieve what is perhaps one of the most important reasons we are on the planet: to reproduce, to have offspring.

Q. With all that has been written about the octuplet case, has anything been lost in the debate?

A. What has been lost is the sacrifice, the hours and hours of work that have gone into creating a treatment for infertility that is successful and the incredible amount of joy we have been able to bring to families.

Q. Besides implanting more embryos, what else can be done to improve an infertile couple’s odds of having a baby?

A. Research is being done on identifying the best embryo to implant, trying to find markers of embryo implantation potential. We’re also looking at methods for identifying the best egg.

Q. How is that research going?

A. I predict that five years from now you’ll see many more single-embryo transfers. There has to be a coalition of events: technological advances, better insurance coverage, less competition among clinics, but I am convinced that in a few years, this is going to happen, and higher order pregnancies from IVF will be history.

—Jennifer Kaylin

Photo by Jennifer Kaylin

To find out more about the Society for Assisted Reproductive Technology or to view clinical survey reports from any center in the United States, go to www.sart.org.

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Tuesday, March 24, 2009

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.

Wednesday, March 18, 2009

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.

Tuesday, March 3, 2009

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.