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Treatment of Infertility in Women With Polycystic Ovary Syndrome

NCT ID: NCT00068861

Last Updated: 2007-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

678 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome Infertility Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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metformin XR

Intervention Type DRUG

clomiphene citrate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of California at San Diego

La Jolla, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Wayne State

Detroit, Michigan, United States

Site Status

University of Medicine and Dentistry New Jersey

Newark, New Jersey, United States

Site Status

Penn State

Hershey, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.cct.2005.01.006.

Reference Type BACKGROUND
PMID: 15911461 (View on PubMed)

Chan JL, Legro RS, Eisenberg E, Pisarska MD, Santoro N. Correlation of Polycystic Ovarian Syndrome Phenotypes With Pregnancy and Neonatal Outcomes. Obstet Gynecol. 2024 Oct 1;144(4):543-549. doi: 10.1097/AOG.0000000000005702. Epub 2024 Aug 22.

Reference Type DERIVED
PMID: 39173182 (View on PubMed)

Komorowski AS, Hughes L, Sarkar P, Aaby DA, Kumar A, Kalra B, Legro RS, Boots CE. Antimullerian hormone level predicts ovulation in women with polycystic ovary syndrome treated with clomiphene and metformin. Fertil Steril. 2024 Apr;121(4):660-668. doi: 10.1016/j.fertnstert.2023.12.031. Epub 2023 Dec 26.

Reference Type DERIVED
PMID: 38154770 (View on PubMed)

Kuang H, Jin S, Thomas T, Engmann L, Hansen KR, Coutifaris C, Casson P, Christman G, Alvero R, Santoro N, Eisenberg E, Diamond MP, Legro RS, Zhang H; Reproductive Medicine Network. Predictors of participant retention in infertility treatment trials. Fertil Steril. 2015 Nov;104(5):1236-43.e1-2. doi: 10.1016/j.fertnstert.2015.08.001. Epub 2015 Sep 3.

Reference Type DERIVED
PMID: 26354094 (View on PubMed)

Legro RS. Pregnancy in polycystic ovary syndrome I: lessons from a pragmatic explanatory with repository clinical trial. Semin Reprod Med. 2015 May;33(3):213-9. doi: 10.1055/s-0035-1552920. Epub 2015 Jun 2.

Reference Type DERIVED
PMID: 26036903 (View on PubMed)

Legro RS, Chen G, Kunselman AR, Schlaff WD, Diamond MP, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers ER, Zhang H, Foulds J; Reproductive Medicine Network. Smoking in infertile women with polycystic ovary syndrome: baseline validation of self-report and effects on phenotype. Hum Reprod. 2014 Dec;29(12):2680-6. doi: 10.1093/humrep/deu239. Epub 2014 Oct 16.

Reference Type DERIVED
PMID: 25324541 (View on PubMed)

Roth LW, Huang H, Legro RS, Diamond MP, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers ER, Zhang H, Schlaff WD; Reproductive Medicine Network. Altering hirsutism through ovulation induction in women with polycystic ovary syndrome. Obstet Gynecol. 2012 Jun;119(6):1151-6. doi: 10.1097/AOG.0b013e31825618fb.

Reference Type DERIVED
PMID: 22617579 (View on PubMed)

Aubuchon M, Kunselman AR, Schlaff WD, Diamond MP, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers ER, Legro RS; Reproductive Medicine Network. Metformin and/or clomiphene do not adversely affect liver or renal function in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2011 Oct;96(10):E1645-9. doi: 10.1210/jc.2011-1093. Epub 2011 Aug 10.

Reference Type DERIVED
PMID: 21832111 (View on PubMed)

Schlaff WD, Zhang H, Diamond MP, Coutifaris C, Casson PR, Brzyski RG, Christman GM, Barnhart KT, Trussell JC, Krawetz SA, Snyder PJ, Ohl D, Santoro N, Eisenberg E, Huang H, Legro RS; Reproductive Medicine Network. Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies. Fertil Steril. 2011 Jul;96(1):15-8. doi: 10.1016/j.fertnstert.2011.05.069. Epub 2011 Jun 8.

Reference Type DERIVED
PMID: 21645894 (View on PubMed)

Legro RS, Schlaff WD, Diamond MP, Coutifaris C, Casson PR, Brzyski RG, Christman GM, Trussell JC, Krawetz SA, Snyder PJ, Ohl D, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers ER, Santoro N, Eisenberg E, Zhang M, Zhang H; Reproductive Medicine Network. Total testosterone assays in women with polycystic ovary syndrome: precision and correlation with hirsutism. J Clin Endocrinol Metab. 2010 Dec;95(12):5305-13. doi: 10.1210/jc.2010-1123. Epub 2010 Sep 8.

Reference Type DERIVED
PMID: 20826578 (View on PubMed)

Rausch ME, Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER, Coutifaris C; Reproductive Medicine Network. Predictors of pregnancy in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2009 Sep;94(9):3458-66. doi: 10.1210/jc.2009-0545. Epub 2009 Jun 9.

Reference Type DERIVED
PMID: 19509098 (View on PubMed)

Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Ewens KG, Spielman RS, Leppert PC, Myers ER; Reproductive Medicine Network. Ovulatory response to treatment of polycystic ovary syndrome is associated with a polymorphism in the STK11 gene. J Clin Endocrinol Metab. 2008 Mar;93(3):792-800. doi: 10.1210/jc.2007-1736. Epub 2007 Nov 13.

Reference Type DERIVED
PMID: 18000088 (View on PubMed)

Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66. doi: 10.1056/NEJMoa063971.

Reference Type DERIVED
PMID: 17287476 (View on PubMed)

Other Identifiers

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NICHD-PPCOS

Identifier Type: -

Identifier Source: org_study_id