The purpose of this three-armed randomized study is to establish the relative roles of treatment of hyperandrogenism versus obesity in treating infertility and improving pregnancy outcomes among obese PCOS women. Phase I of this study will be a randomized trial of three interventions in infertile women with PCOS. 

• The first arm will be a combined intervention of medication, meal replacements, and lifestyle modification to improve insulin resistance. Alli is a medication associated with increased fullness and a resulting reduction in food intake. 

• The second arm will be the use of a continuous oral contraceptive pill for 4 months to improve hyperandrogenism. Lo-Estrin will be used in a continuous method for 4 months to suppress the ovary.     

• The third arm is the combination of both improved hyperandrogenism and insulin resistance.

The study involves traveling to the Penn State Milton S. Hershey Medical Center in Hershey, PA or the University of Pennsylvania in Philadelphia, PA. Phase I will include visits every month after a screening visit, randomization visit and a two week follow up visit over a 4-month period. Phase II will consist of up to 4 cycles of ovulation induction. If conception is obtained, Phase III will involve a per trimester basis (3 visits total) and a follow-up visit 3 months post partum for a DXA scan.

Adult women (ages 18-40 years) who have the following:

• Periods 45 or more days apart OR have less than 8 periods per year 

• Have elevated testosterone levels OR have hirsutism score of >8  OR have polycystic ovaries (diagnosed by ultrasound) 

• BMI=27-42

 The procedures that will take place in Phase I include a pregnancy test, medical history, physical exam, blood pressure, height and weight measurements, review of medications and adverse events, hirsutism and acne score, dietary and exercise counseling. Blood work will be done to determine sex hormone levels and other hormones in the body at the initial visit, randomization visit, monthly visit, and at the end of phase visit. An EKG will be done at the screening visit. DXA scanning will be done at randomization and end of phase visits. Transvaginal ultrasound will be done at the screening visit and end of phase visit. Bleeding, exercise, and dietary diaries will be collected at each visit.

Phase II procedures will include a pregnancy test, blood pressure, height and weight measurements, review of medications and adverse events, hirsutism and acne score. Blood work will be done to determine sex hormone levels and other hormones in the body at the start of phase visit, monthly visit, and at the end of phase visit. DXA scanning and a treadmill exercise test will be done at the start of phase visit and end of phase visit. Transvaginal ultrasound will be done at the start and end of phase visits and monthly visits. 

Phase III procedures include blood pressure, height and weight measurements, hirsutism and acne score, blood work to determine sex hormone levels and other hormones, review of medications and adverse events, review of diet and exercise diaries at each trimester visit. A treadmill exercise test will be done at the final visit.

This study is under the direction of Dr. Richard S. Legro of the Department of OB/GYN, Division of Reproductive Endocrinology at the Penn State Milton S. Hershey Medical Center in Hershey, PA and Dr. Christos Coutifaris of the Department of OB/GYN, Division of Reproductive Endocrinology and Infertility at the University of Pennsylvania in Philiadelphia, PA.

• Penn State Milton S. Hershey Medical Center in Hershey, PA
• University of Pennsylvania in Philadelphia, PA.

• Penn State Milton S. Hershey Medical Center Study Coordinator - Patsy Rawa at 1-800-585-9585 or 717-531-3692
• University of Pennsylvania Study Coordinator – Karen Lecks at 1-215-349-5201