Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women
Information source: Penn State University
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Orlistat (Alli) and Lifestyle Intervention with exercise and diet (Drug); Loestrin 1/20 (Drug); Orlistat (Alli) and Loestrin 1/20 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Penn State University Official(s) and/or principal investigator(s):
Richard S Legro, M.D., Principal Investigator, Affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Christos Coutifaris, M.D., Ph.D., Principal Investigator, Affiliation: Universtiy of Pennsylvania, Department of Obstetrics and Gynecology
Overall contact:
Patricia D Rawa, BS, Phone: 717-531-3692, Email: prawa@hmc.psu.edu
Summary
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.
Clinical Details
Official title: Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Identify the effects of weight loss vs. OCP therapy on the PCOS reproductive phenotype
Secondary outcome: 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.
Detailed description:
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. Orlistat is a gastric lipase inhibitor that reduces the
absorption of fat contained in a meal by about 30%. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Patricia D Rawa, BS, Phone: 717-531-3692, Email: prawa@hmc.psu.edu
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Richard S. Legro, M.D., Phone: 717-531-8478, Email: rsl1@psu.edu
Patsy Rawa, B.S., Phone: 717-531-3692, Email: prawa@psu.edu
Richard S Legro, M.D., Principal Investigator
University of Pennsylvania, Department of Obstetrics and Gynecology, Philadelphia, Pennsylvania 19104, United States; Recruiting
Christos Coutifaris, M.D., Ph.D., Phone: 215-662-6100, Email: ccoutifaris@obgyn.upenn.edu
Karen Lecks, Phone: 215-349-5201, Email: klecks@obgyn.upenn.edu
Christos Coutifaris, M.D., Ph.D., Principal Investigator
Additional Information
Click here for more information about this study.
Starting date: September 2008
Last updated: November 22, 2011
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