Treatment of Infertility in Women With Polycystic Ovary Syndrome
Information source: National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome; Infertility; Pregnancy
Intervention: metformin XR (Drug); clomiphene citrate (Drug)
Phase: Phase 3
Sponsored by: National Institute of Child Health and Human Development (NICHD)
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.
Official title: Pregnancy in Polycystic Ovary Syndrome: A 30 Week Double-Blind Randomized Trial of Clomiphene Citrate, Metformin XR, and Combined Clomiphene Citrate/Metformin XR For the Treatment of Infertility in Women With Polycystic Ovary Syndrome
Study design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Live birth rate
singleton live birth rate
cycles to first ovulation
cycles to conception
cycles to pregnancy
weeks from pregnancy to live birth
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.
Minimum age: 18 Years.
Maximum age: 39 Years.
- Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days
- Elevated testosterone level
- Good general health
- Sperm concentration in partner of 20 million/ml or greater
- Ability to have intercourse 2-3 times per week
- One functional fallopian tube and normal uterine cavity
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35249, United States
Stanford University, Stanford, California 94305, United States
University of California at San Diego, La Jolla, California 92037, United States
University of Colorado, Aurora, Colorado 80045, United States
Wayne State, Detroit, Michigan 48201, United States
University of Medicine and Dentistry New Jersey, Newark, New Jersey 07103, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Penn State, Hershey, Pennsylvania 17033, United States
Baylor College of Medicine, Houston, Texas 77030, United States
University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States
Virginia Commonwealth University, Richmond, Virginia 23298, United States
Myers ER, Silva SG, Hafley G, Kunselman AR, Nestler JE, Legro RS; National Institute of Child Health and Human Development Reproductive Medicine Network. Estimating live birth rates after ovulation induction in polycystic ovary syndrome: sample size calculations for the pregnancy in polycystic ovary syndrome trial. Contemp Clin Trials. 2005 Jun;26(3):271-80.
Starting date: November 2002
Ending date: February 2006
Last updated: September 28, 2007