The purpose of this study double-blind, randomized trial is to determine which of these two medications, Clomiphene Citrate or Letrozole, will most likely result in a pregnancy and live birth in women with PCOS.
The study involves traveling to Penn State Milton S. Hershey Medical Center in Hershey, PA. You will participate in this study for approximately 24 weeks or 5 cycles of study medication. During this study, you will have a total of 13 visits, a screening visit, baseline visit, and monthly visits, as well as a termination visit at the end of the study.
The procedures that will take place during the screening visits include assessment of your medical history, completion of questionnaires related to your physical, mental and sexual function. You will have a physical examination including a pap smear (if not done within the past year), measurements such as height & weight, vital signs, hip & waist, and an assessment of your acne, sebum (oil in the skin) & hirsutism (excessive body hair). You will have screening blood work done to determine eligibility for the study. You will have an ultrasound performed to look at your uterus and ovaries. If you have never had a test to determine if your fallopian tubes are open, a sonohysterogram will be performed at the time of the ultrasound. A semen analysis is required to determine a sperm concentration of greater than 14million/mL for entry into the study. Your partner/spouse will need to provide a sample of semen for testing. The monthly visits will take place during the middle of your menstrual cycle or approximately 3 weeks after you take your study medication. These visits will involve brief physical exams, measurements, blood work, ultrasound, and review of your daily journal. The secondly monthly visit will occur 2 weeks after the first one to have only a blood pregnancy test done before you start your next cycle. A final termination visit will be done after you have completed all of the study medication or if you have become pregnant. If you become pregnant, we will follow you throughout the pregnancy for complications and outcomes.

• Periods >= 45 days or <= 8 menses per year
• Elevated testosterone of > 50 ng/dl or hirsutism score of > 8 or polycystic ovaries on ultrasound
• 18-40 years of age

Penn State Milton S. Hershey Medical Center Study Coordinator- Jamie Ober, RN at 1-800-585-9585 or 717-531-6272 or email jober@hmc.psu.edu