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

NCT00413179 | Completed Phase 3

• 1 other identifier: FWH19970383H
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome; Anovulation; Oligoovulation; Infertility; Hyperandrogenism

Keywords

Polycystic Ovarian Syndrome; Chronic Anovulation; Chronic Oligoovulation; Infertility; Hyperandrogenism; Metformin; Ovulation induction

Outcome Measures

Primary Outcomes (2)

• Pregnancy Rates

• Ovulation Rates

Secondary Outcomes (1)

• Pregnancy Outcome

Interventions

Metformin DRUG

Clomiphene citrate DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• 59th Medical Wing: lead

Study Sites (1)

Wiford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Anovulation; Infertility; Hyperandrogenism

Interventions

Metformin; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Randal D Robinson, MD

  Wilford Hall Medical Center and Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: December 1, 1997
• Study Completion: April 1, 2003
• Last Updated: December 19, 2006

Record last verified: 2006-12

Locations

US (1)