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Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women (OWL-PCOS)
This study is currently recruiting participants.
Study NCT00704912   Information provided by Penn State University
First Received: June 23, 2008   Last Updated: September 8, 2009   History of Changes

June 23, 2008
September 8, 2009
September 2008
March 2013   (final data collection date for primary outcome measure)
Identify the effects of weight loss vs. OCP therapy on the PCOS reproductive phenotype [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Identify the effects of weight loss vs. OCP therapy on the PCOS reproductive phenotype. Pretreatment with OCP will most improve the preconception PCOS phenotype compared to weight loss, and the combination of both will be the best. [ Time Frame: Assessed during data analysis ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00704912 on ClinicalTrials.gov Archive Site
Compare impact of weight loss vs. OCP vs. the combination of both on the live birth rate. The live birth rate will be lowest in the weight loss group, higher in the OCP group and highest in the group treated with both. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Compare impact of weight loss vs. OCP vs. the combination of both on the live birth rate. The live birth rate will be lowest in the weight loss group, higher in the OCP group and highest in the group treated with both. [ Time Frame: At time of data analysis ] [ Designated as safety issue: No ]
 
Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women
Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women

The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The investigators hypothesize that the key to restoring ovulation leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the key to avoiding later pregnancy complications is to improve insulin sensitivity with weight loss.

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among women, and women with PCOS are at increased risk for pregnancy complications such as gestational diabetes and pre-eclampsia. Both hyperandrogenism (HA) and obesity exacerbated insulin resistance (IR) are characteristics of the syndrome, and are targets for treatment, but which should be the predominant focus is still unknown. Phase 1 of this study will be a randomized trial of three preconception interventions in infertile women with PCOS. The first arm will be a combined intervention of medication, meal replacements, and lifestyle modification to improve IR. Sibutramine is a combined norepinephrine-serotonin re-uptake inhibitor that is associated with increased satiation (fullness) and a resulting reduction in food intake. The second arm will be the use of a continuous OCP for 4 months to improve HA. Lo-Estrin 1/20 will be used in a continuous method for 4 months to suppress the ovary. The third arm is the combination of both to improve HA an IR. Phase II of this study will involve ovulation induction with clomiphene citrate with hopeful outcome of pregnancy. Finally, Phase III involve following the pregnancies for outcomes and complications.

Phase II
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Polycystic Ovary Syndrome
  • Drug: Sibutramine (Meridia) and Lifestyle Intervention with exercise and diet
  • Drug: Loestrin 1/20
  • Drug: Sibutramine (Meridia) and Loestrin 1/20
  • Active Comparator: Weight Loss via Medication/Meal Replacement/Lifestyle Modification
  • Active Comparator: Reducing HA will consist of continuous low dose OCP
  • Active Comparator: Combination of treatments from Arm A and Arm B
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
246
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Partner with sperm concentration of >=14 million/mL in at least one ejaculate with motile sperm.
  • Ability to have regular intercourse 2-3 times per week during the ovulation induction phase of study.
  • At least on patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years.
  • No previous sterilization procedures(vasectomy, tubal ligation) tha have been reversed.

Exclusion Criteria:

  • Intermenstrual periods of >= 45 days or a total of <=8 periods per year.
  • Elevated total testosterone >50 ng/dL.
  • PCO on ultrasound (12 or more follicles measuring 2-9 mm in diameter).
  • BMI >=27 to <=40.
Female
18 Years to 40 Years
Yes
Contact: Patricia D Rawa, BS 717-531-3692 prawa@hmc.psu.edu
Contact: Karen Lecks 215-349-5201 klecks@obgyn.upenn.edu
United States
 
NCT00704912
Dr. Richard S. Legro, M.D., Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
27184, 1 RO1 HD056510-01 A1
Penn State University
University of Pennsylvania
Principal Investigator: Richard S Legro, M.D. Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Principal Investigator: Christos Coutifaris, M.D., Ph.D. Universtiy of Pennsylvania, Department of Obstetrics and Gynecology
Penn State University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP