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

Completed · Phase 3 · Has a placebo group

Conditions studied: Polycystic Ovary Syndrome, Anovulation, Oligoovulation, Infertility, Hyperandrogenism

In brief

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.

Key facts

Study ID

NCT00413179

Run by

59th Medical Wing

People needed

56

Starts

1997-12-01

Expected to finish

2003-04-01

Last updated by the study team

2006-12-19

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wiford Hall Medical Center — Lackland Air Force Base, Texas, United States

Full record on ClinicalTrials.gov

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