Treatment of Infertility in Women With Polycystic Ovary Syndrome

Overview[ - collapse ][ - ]

Purpose 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.
ConditionPolycystic Ovary Syndrome
Infertility
Pregnancy
InterventionDrug: metformin XR
Drug: clomiphene citrate
PhasePhase 3
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible PartyEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov IdentifierNCT00068861
First ReceivedSeptember 10, 2003
Last UpdatedSeptember 28, 2007
Last verifiedSeptember 2005

Tracking Information[ + expand ][ + ]

First Received DateSeptember 10, 2003
Last Updated DateSeptember 28, 2007
Start DateNovember 2002
Estimated Primary Completion DateFebruary 2006
Current Primary Outcome MeasuresLive birth rate
Current Secondary Outcome Measures
  • singleton live birth rate
  • ovulation rate
  • cycles to first ovulation
  • cycles to conception
  • abortion rate
  • cycles to pregnancy
  • weeks from pregnancy to live birth

Descriptive Information[ + expand ][ + ]

Brief TitleTreatment of Infertility in Women With Polycystic Ovary Syndrome
Official TitlePregnancy 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
Brief 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.
Detailed 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.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Condition
  • Polycystic Ovary Syndrome
  • Infertility
  • Pregnancy
InterventionDrug: metformin XR
Drug: clomiphene citrate
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment678
Estimated Completion DateFebruary 2006
Estimated Primary Completion DateNot Provided
Eligibility 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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00068861
Other Study ID NumbersNICHD-PPCOS
Has Data Monitoring CommitteeNot Provided
Information Provided ByEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorsNot Provided
Investigators Not Provided
Verification DateSeptember 2005

Locations[ + expand ][ + ]

University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
University of California at San Diego
La Jolla, California, United States, 92037
Stanford University
Stanford, California, United States, 94305
University of Colorado
Aurora, Colorado, United States, 80045
Wayne State
Detroit, Michigan, United States, 48201
University of Medicine and Dentistry New Jersey
Newark, New Jersey, United States, 07103
Penn State
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Virginia Commonwealth University
Richmond, Virginia, United States, 23298