Treatment of Infertility in Women With Polycystic Ovary Syndrome

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Overall Status

Completed

CT.gov ID

NCT00068861

Collaborator

(none)

678

Enrollment

Locations

Duration (Months)

61.6

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Infertility Pregnancy	Drug: metformin XR Drug: clomiphene citrate	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2002

Actual Study Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

Live birth rate []

Secondary Outcome Measures

singleton live birth rate []
ovulation rate []
cycles to first ovulation []
cycles to conception []
abortion rate []
cycles to pregnancy []
weeks from pregnancy to live birth []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249
2	University of California at San Diego	La Jolla	California	United States	92037
3	Stanford University	Stanford	California	United States	94305
4	University of Colorado	Aurora	Colorado	United States	80045
5	Wayne State	Detroit	Michigan	United States	48201
6	University of Medicine and Dentistry New Jersey	Newark	New Jersey	United States	07103
7	Penn State	Hershey	Pennsylvania	United States	17033
8	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
9	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
10	Baylor College of Medicine	Houston	Texas	United States	77030
11	Virginia Commonwealth University	Richmond	Virginia	United States	23298