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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


Phase 3
18 Years
39 Years
Not Enrolling
Female
Polycystic Ovary Syndrome, Infertility, Pregnancy

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Live birth rate

Authority:

United States: Food and Drug Administration

Study ID:

NICHD-PPCOS

NCT ID:

NCT00068861

Start Date:

November 2002

Completion Date:

February 2006

Related Keywords:

  • Polycystic Ovary Syndrome
  • Infertility
  • Pregnancy
  • Infertility
  • Polycystic Ovary Syndrome

Name

Location

Baylor College of MedicineHouston, Texas  77030
Stanford UniversityStanford, California  94305
University of ColoradoDenver, Colorado  80217
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of California at San DiegoLa Jolla, California  92093
University of Texas Southwestern Medical CenterDallas, Texas  
Virginia Commonwealth UniversityRichmond, Virginia  
Wayne StateDetroit, Michigan  48201
University of Medicine and Dentistry New JerseyNewark, New Jersey  07103
Penn StateHershey, Pennsylvania  17033