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Home > "T" Clinical Trials Conditions > Treatment of Infertility in Women With Polycystic Ovary Syndrome  Treatment of Infertility in Women With Polycystic Ovary Syndrome
Treatment of Infertility in Women With Polycystic Ovary Syndrome
For Condition: Infertility,Polycystic Ovary Syndrome,Pregnancy
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/39 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer - 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
Total Enrollment: 678
Location and Contact Information:
Virginia Commonwealth University *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Manar Nazmy 804-828-2663
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35249
United States
Recruiting Laticia Love 205-848-1760
University of Texas Southwestern Medical Center *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Micki Roark 214-648-7138
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Missy Torres 713-798-7549
University of Colorado *Recruiting*
Aurora, Colorado, 80045
United States
Recruiting Kristi Gatlin 720-848-1688
University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Linda Martino 215-615-3664
Stanford University *Recruiting*
Stanford, California, 94305
United States
Recruiting Kathy Turner 650-736-1802
University of Medicine and Dentistry New Jersey *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Amy Solnica 973-972-3633
Penn State *Recruiting*
Hershey, Pennsylvania, 17033
United States
Recruiting Jamie Ober 717-531-6272
University of California at San Diego *Recruiting*
La Jolla, California, 92037
United States
Recruiting Geri Schmotzer 858-822-3416
Wayne State *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Michelle Brossoit 313-745-7885
Additional Information:
Study ID Numbers: NICHD-PPCOS;
Study Start Date: November 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068861
Other Polycystic Ovary Syndrome Studies:
1. Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
2. Treatment of Infertility in Women With Polycystic Ovary Syndrome
3. Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
4. Phase II Study of the Effect of Leuprolide Acetate and Spironolactone on Insulin Resistance in Hyperandrogenic Women with Polycystic Ovarian Disease or Hyperandrogenism Insulin Resistance Acanthosis Nigricans Syndrome
Related Studies:
Other Polycystic Ovary Syndrome Clinical Trials
Other Pennsylvania Clinical Trials
Other Hershey Clinical Trials
Treatment of Infertility in Women With Polycystic Ovary Syndrome
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