The Effect of Metformin Added to Clomiphene Citrate on Pregnancy Rates in Hyperandrogenic, Chronic Oligoovulatory or Anovulatory Women

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of our study was to conduct a placebo controlled, double-blind randomized trial in chronic oligoovulatory or anovulatory , hyperandrogenic, infertility patients comparing the effects of adjuvant metformin plus clomiphene citrate to clomiphene citrate plus placebo on pregnancy rates and ovulation rates. We hypothesized that combining metformin with clomiphene citrate would result in higher ovulation and pregnancy rates in hyperandrogenic women who have chronic oligoovulation or anovulation as the sole etiology for their infertility and who have unknown responsiveness to clomiphene citrate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: 59th Medical Wing; Wilford Hall Medical Center
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Metformin; Zuclomiphene

Criteria

Inclusion Criteria:

• Married

• Hyperandrogenic women 18-40 years old who desired fertility and who demonstrated chronic anovulation or oligoovulation

• Had patent fallopian tubes and whose partners had normal semen analyses were eligible for enrollment in the study.

Exclusion Criteria:

• Androgen secreting tumours

• Diabetes mellitus

• Thyroid abnormalities

• Hyperprolactinemia

• Adult onset congenital adrenal hyperplasia

• Diminished ovarian reserve

• Subjects who used hormonal medications two months prior to the start of the trial.