Treatment of Infertility in Women With Polycystic Ovary Syndrome
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Ovary Syndrome Infertility Pregnancy |
Drug: metformin XR Drug: clomiphene citrate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- Live birth rate
- singleton live birth rate
- ovulation rate
- cycles to first ovulation
- cycles to conception
- abortion rate
- cycles to pregnancy
- weeks from pregnancy to live birth
| Estimated Enrollment: | 678 |
| Study Start Date: | November 2002 |
| Study Completion Date: | February 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| United States, California | |
| University of California at San Diego | |
| La Jolla, California, United States, 92037 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Michigan | |
| Wayne State | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| University of Medicine and Dentistry New Jersey | |
| Newark, New Jersey, United States, 07103 | |
| United States, Pennsylvania | |
| Penn State | |
| Hershey, Pennsylvania, United States, 17033 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00068861 History of Changes |
| Other Study ID Numbers: | NICHD-PPCOS |
| Study First Received: | September 10, 2003 |
| Last Updated: | September 28, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Infertility Fertility Agents, Female Fertility Agents Polycystic Ovary Syndrome Genital Diseases, Male Genital Diseases, Female Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Citric Acid Clomiphene |
Metformin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Reproductive Control Agents Selective Estrogen Receptor Modulators Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 19, 2013