Treatment of Infertility in Women With Polycystic Ovary Syndrome
- Conditions
- Polycystic Ovary SyndromeInfertilityPregnancy
- Registration Number
- NCT00068861
- Lead Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Brief Summary
Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women. The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair, acne, and infertility. This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility.
- Detailed Description
PCOS is characterized by excess circulating androgen levels and chronic anovulation. The fundamental pathophysiologic defect is unknown, but PCOS is characterized by insulin resistance and compensatory hyperinsulinemia. Improvements in insulin sensitivity in PCOS women, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. Resumption of ovulation occurs in up to 70% of women treated for PCOS. This study will evaluate the safety and effectiveness of clomiphene citrate and metformin XR in achieving a successful pregnancy in infertile PCOS women.
Women with PCOS who are seeking pregnancy will be enrolled in this study. Women will be randomized to one of three different treatment arms: A) metformin XR 1000 mg twice/day; B) clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle); or C) metformin XR 1000 mg twice/day with clomiphene citrate 50 mg/day for 5 days (day 3-7 of cycle). Women will continue on study medications for 30 weeks, 6 treatment cycles, or until they become pregnant. Progesterone levels will be drawn weekly to monitor ovulation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 678
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Live birth rate
- Secondary Outcome Measures
Name Time Method singleton live birth rate ovulation rate cycles to first ovulation cycles to conception abortion rate cycles to pregnancy weeks from pregnancy to live birth
Trial Locations
- Locations (11)
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Medicine and Dentistry New Jersey
🇺🇸Newark, New Jersey, United States
University of California at San Diego
🇺🇸La Jolla, California, United States
Wayne State
🇺🇸Detroit, Michigan, United States
Penn State
🇺🇸Hershey, Pennsylvania, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Stanford University
🇺🇸Stanford, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States