Treatment of Infertility in Women With Polycystic Ovary Syndrome

United States Department of Health and Human Services (HHS)

Status and phase

Completed

Phase 3

Conditions

Infertility

Polycystic Ovary Syndrome

Pregnancy

Treatments

Drug: clomiphene citrate

Drug: metformin XR

Study type

Interventional

Funder types

NIH

Identifiers

NCT00068861

NICHD-PPCOS

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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