Researchers at Penn State Milton S. Hershey Medical Center and the University of Pennsylvania are studying the effects of weight loss on the ability to conceive in women with polycystic ovary syndrome (PCOS) and have been awarded a $3.1 million grant from the National Institutes of Health. Volunteers are needed for this study, the first to test the effects of preconception weight loss in a controlled clinical research study. While weight loss is generally consistent with an improvement in health quality, it is unknown whether weight loss just prior to pregnancy improves outcomes, as stored energy in fat may be helpful for a pregnancy. This study will attempt to answer the bigger question of whether fat is a friend or foe to pregnancy in these women.
PCOS is an ovarian disorder with infrequent ovulation, and women are commonly overweight. PCOS can markedly decrease a woman’s ability to get pregnant. The best fertility treatment for overweight women with PCOS is debated among experts and one the study hopes to identify.
The study is examining the effects of pretreatment with weight loss (to reduce fat), oral contraceptives (which improve the ovarian disorder), or the combination of both on pregnancy outcomes in infertile, obese women. Researchers hope to determine which pretreatment strategy leads to the best chance for pregnancy and a live birth.
Women ages 18 to 40 may be eligible if they are overweight, have infrequent menstrual periods or signs of an ovarian disorder, such as excess body hair or elevated androgen (e.g. Testosterone) levels. Women who qualify for the study will receive their preconception intervention and infertility treatment without cost as part of the study.
This study is under the direction of Dr. Richard S. Legro of the Department of OB/GYN, Division of Reproductive Endocrinology at Penn State Hershey Medical Center and Dr. Christos Coutifaris, Reproductive Research Unit at the University of Pennsylvania, Philadelphia. Legro and Coutifaris are building on the results of their prior study, a comprehensive effort to compare two drugs in helping women with PCOS achieve successful pregnancy. The main finding of that study was a lead article in the New England Journal of Medicine, and the drug found to have the best success rate in that study will be used in this study. The investigators are looking to boost the delivery rate of healthy infants with this drug by adding a pretreatment intervention.
For more information, contact study coordinators Patsy Rawa (Penn State Hershey Medical Center) at (717) 531-3692 or Karen Lecks, M.S.N., C.R.N.P., (University of Pennsylvania) at (215) 349-5201.