Study Cites (PGD) As A Tool For Lowering Multifetal Pregnancy Rates

Dr. Lawrence B. Werlin, Co-Founder of GENESIS Network for
Reproductive Health, Assists Couples in Building Their Families

IRVINE, California—Oct. 30, 2006—The American Society for Reproductive Medicine invited Dr. Lawrence B. Werlin to present his findings on a study that addressed the alarmingly high U.S. multifetal pregnancy rates, stemming from use of Assisted Reproductive Technologies (ART), at its annual ASRM conference. The important conference featured presentations from the world’s leading researchers in reproductive medicine and took place Oct. 21-25 in New Orleans, Louisiana. Werlin’s presentation focused on his Institutional Review Board (IRB)-approved, prospective study, which analyzed the use of Preimplantation Genetic Diagnosis (PGD) in reducing the instance of multifetal pregnancy associated with in-vitro fertilization (IVF) in women of advanced maternal age (over 38 years) and those in high-risk categories.

Recently the March of Dimes and the American College of Obstetricians and Gynecologists, in conjunction with the American Society of Reproductive Medicine, issued a joint statement emphasizing the importance of reducing the risk of pre-term birth in women undergoing fertility treatment. Curbing the instance of multiple births may effectively limit the occurrence of pre-term birth complications. Werlin’s study was conducted in response to research that indicated multiple birth rates in the United States had grown by 59 percent in the last two decades. The Center for Disease Control and Prevention (CDC) reported that 1 in 18 births to women age 35 and over results in a multiple delivery, an outcome associated primarily with infertility treatments. The problem with multiple births, and the reason the growing trend needs to be addressed, is that they present inherent risks to both mother and children, such as maternal anemia, low infant birth weights and cerebral palsy. The March of Dimes medical director Nancy Green publicly stated that multiple births are often fraught with complications. “More than half of twins and nearly all triplets are born prematurely,” she explained, “associated with an increased risk of death and disability.” Werlin’s study aimed to combat the growing trend.

PGD is a genetic testing tool that allows for the analysis and transfer of healthy embryos back into the uterus. In Werlin’s study, participants were randomized into either control or PGD groups before undergoing stimulation protocols. Intracytoplasmic sperm injection (ICSI) was performed on all previously retrieved mature oocytes. In the PGD group, chromosomal analysis was conducted on all six to eight cell embryos on day three post retrieval.

Results were received day four post retrieval. Using PGD, Dr. Werlin determined which embryos were chromosomally normal, before selecting just two for embryo transfer. In the control group, two embryos were also selected for transfer. Rising hormone B-hCG levels confirmed pregnancy. “Through the study, we speculated that PGD could be the antidote to minimizing the occurrence of multiple births occurring as a result of IVF’s success,” Dr. Werlin said. “By using PGD to screen for the healthiest embryos, we showed that transferring two or less embryos to the woman could equally achieve pregnancy success while lowering the rate of multiple births. PGD assisted by detecting genetic abnormalities in the embryos that would have otherwise gone undetected and negatively affected pregnancy outcomes.”

Werlin’s presentation entitled, “Preimplantation Genetic Diagnosis (PGD) as a Tool to Lower Multifetal Pregnancy Rates” concluded that transferring no more than two, day- five embryos resulted in a low multifetal pregnancy rate per transfer. Furthermore, there were no multifetal gestations in the PGD group, which had been analyzed for chromosomal normality prior to embryo transfer. [Two multifetal pregnancies occurred within the control group.] Additionally, by limiting the number of day-five embryos per transfer, the multifetal pregnancy rate was significantly reduced.

Couples hoping to increase their chances of successfully becoming pregnancy frequently choose to implant three or more embryos, often resulting in a higher number of multiple birth pregnancies. Since 1980, the overall number of twin births has risen about 65 percent and triplet birth rates have grown by 500 percent, according to the National Institute of Health. The jump in multiple birth rates coincided with the introduction of in-vitro fertilization in the United States. At the heart of Werlin’s PGD study was his desire to protect both mother and child. “The study demonstrated that limiting the number of embryos transferred in IVF significantly reduced maternal and infant health risks associated with multiple births,” Dr. Werlin said. “The data provided vital information to the health community and mass public.” As an added benefit, it could also lead to other advances in reproductive medicine, such as an increase in insurance coverage for fertility treatments.

Dr. Werlin led GENESIS on the first randomized prospective PGD study, earning national acclaim. That study gave women in high-risk categories, including women 38 years and older and those with recurring pregnancy loss, answers never before made available regarding their chances for increasing pregnancy success through in-vitro fertilization. The study concluded that PGD can facilitate a successful pregnancy and avoid in-vitro fertilization failures due to chromosomal imbalances.

Dr. Werlin is a leader in reproductive technology, research, education and patient services, and co-founder of GENESIS Network for Reproductive Health, a team of nationally noted fertility specialists. He is also the founder and director of Coastal Fertility Medical Center in Irvine, Calif. and co-founder of Corona Institute for Reproductive Medicine & Fertility in Corona, Calif.  Dr. Werlin is a member of the American Society of Reproductive Medicine, Pacific Coast Reproductive Society, and the Society of Assisted Reproductive Technologies, an organization in which he held national office from 1991-2000.  Werlin is currently leading GENESIS in a continuation study regarding the effects of PGD.  For more information, visit www.coastalfertility.com.