Treatment of Infertility in Women With Polycystic Ovary Syndrome

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068861
• Other study ID #: NICHD-PPCOS
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2003
• Last updated: September 28, 2007
• Start date: November 2002
• Est. completion date: February 2006

Study information

• Verified date: September 2005
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovary Syndrome
• Pregnancy
• Syndrome

Intervention

Drug:
• metformin XR

• clomiphene citrate

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Wayne State	Detroit	Michigan
United States	Penn State	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	University of California at San Diego	La Jolla	California
United States	University of Medicine and Dentistry New Jersey	Newark	New Jersey
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Myers ER, Silva SG, Hafley G, Kunselman AR, Nestler JE, Legro RS; National Institute of Child Health and Human Development Reproductive Medicine Network. Estimating live birth rates after ovulation induction in polycystic ovary syndrome: sample size calculations for the pregnancy in polycystic ovary syndrome trial. Contemp Clin Trials. 2005 Jun;26(3):271-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate
Secondary	singleton live birth rate
Secondary	ovulation rate
Secondary	cycles to first ovulation
Secondary	cycles to conception
Secondary	abortion rate
Secondary	cycles to pregnancy
Secondary	weeks from pregnancy to live birth