Treatment of Infertility in Women With Polycystic Ovary Syndrome - Tabular View

Tracking Information
First Received Date ^ICMJE	September 10, 2003
Last Updated Date	September 28, 2007
Start Date ^ICMJE	November 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: September 21, 2005)	Live birth rate
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00068861 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 21, 2005)	singleton live birth rate ovulation rate cycles to first ovulation cycles to conception abortion rate cycles to pregnancy weeks from pregnancy to live birth
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Treatment of Infertility in Women With Polycystic Ovary Syndrome
Official Title ^ICMJE	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
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Condition ^ICMJE	Polycystic Ovary Syndrome Infertility Pregnancy
Intervention ^ICMJE	Drug: metformin XR Drug: clomiphene citrate
Study Arms / Comparison Groups
Publications *	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. 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. Epub 2009 Jun 9. 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. Epub 2007 Nov 13. 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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	678
Completion Date	February 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 39 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00068861
Responsible Party
Study ID Numbers ^ICMJE	NICHD-PPCOS
Study Sponsor ^ICMJE	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date	September 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP