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Treatment of Infertility in Women With Polycystic Ovary Syndrome
This study has been completed.
Study NCT00068861   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: September 10, 2003   Last Updated: September 28, 2007   History of Changes

September 10, 2003
September 28, 2007
November 2002
 
Live birth rate
Same as current
Complete list of historical versions of study NCT00068861 on ClinicalTrials.gov Archive Site
  • singleton live birth rate
  • ovulation rate
  • cycles to first ovulation
  • cycles to conception
  • abortion rate
  • cycles to pregnancy
  • weeks from pregnancy to live birth
Same as current
 
Treatment of Infertility in Women With Polycystic Ovary Syndrome
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

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.

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
  • Polycystic Ovary Syndrome
  • Infertility
  • Pregnancy
  • Drug: metformin XR
  • Drug: clomiphene citrate
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
678
February 2006
 

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
Female
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068861
 
NICHD-PPCOS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP