NCT00068861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
678

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2002

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

October 1, 2007

Status Verified

September 1, 2005

First QC Date

September 10, 2003

Last Update Submit

September 28, 2007

Conditions

Polycystic Ovary SyndromeInfertilityPregnancy

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

Secondary Outcomes (7)

  • singleton live birth rate

  • ovulation rate

  • cycles to first ovulation

  • cycles to conception

  • abortion rate

  • +2 more secondary outcomes

Interventions

metformin XRDRUG
clomiphene citrateDRUG

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of California at San Diego

La Jolla, California, 92037, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Wayne State

Detroit, Michigan, 48201, United States

Location

University of Medicine and Dentistry New Jersey

Newark, New Jersey, 07103, United States

Location

Penn State

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (13)

  • 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.

    PMID: 15911461BACKGROUND

  • 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.

    PMID: 39173182DERIVED

  • 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.

    PMID: 38154770DERIVED

  • 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.

    PMID: 26354094DERIVED

  • 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.

    PMID: 26036903DERIVED

  • 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.

    PMID: 25324541DERIVED

  • 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.

    PMID: 22617579DERIVED

  • 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.

    PMID: 21832111DERIVED

  • 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.

    PMID: 21645894DERIVED

  • 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.

    PMID: 20826578DERIVED

  • 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.

    PMID: 19509098DERIVED

  • 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.

    PMID: 18000088DERIVED

  • 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.

    PMID: 17287476DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

November 1, 2002

Study Completion

February 1, 2006

Last Updated

October 1, 2007

Record last verified: 2005-09

Locations

US(11)