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Treatment of Infertility in Women With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome, Infertility, Pregnancy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
metformin XR
clomiphene citrate
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of California at San Diego
  • Stanford University
  • University of Colorado
  • Wayne State
  • University of Medicine and Dentistry New Jersey
  • Penn State
  • University of Pennsylvania
  • University of Texas Southwestern Medical Center
  • Baylor College of Medicine
  • Virginia Commonwealth University

Outcomes

Primary Outcome Measures

Live birth rate

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

Full Information

First Posted
September 10, 2003
Last Updated
September 28, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00068861
Brief Title
Treatment of Infertility in Women With Polycystic Ovary Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Infertility, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
678 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
metformin XR
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate
Primary Outcome Measure Information:
Title
Live birth rate
Secondary Outcome Measure Information:
Title
singleton live birth rate
Title
ovulation rate
Title
cycles to first ovulation
Title
cycles to conception
Title
abortion rate
Title
cycles to pregnancy
Title
weeks from pregnancy to live birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of California at San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Wayne State
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Medicine and Dentistry New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Penn State
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15911461
Citation
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.
Results Reference
background
PubMed Identifier
26354094
Citation
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.
Results Reference
derived
PubMed Identifier
26036903
Citation
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.
Results Reference
derived
PubMed Identifier
25324541
Citation
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.
Results Reference
derived
PubMed Identifier
22617579
Citation
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.
Results Reference
derived
PubMed Identifier
21832111
Citation
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.
Results Reference
derived
PubMed Identifier
21645894
Citation
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.
Results Reference
derived
PubMed Identifier
20826578
Citation
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.
Results Reference
derived
PubMed Identifier
19509098
Citation
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.
Results Reference
derived
PubMed Identifier
18000088
Citation
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.
Results Reference
derived
PubMed Identifier
17287476
Citation
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.
Results Reference
derived

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Treatment of Infertility in Women With Polycystic Ovary Syndrome

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