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Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women


Phase 2
18 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identify the effects of weight loss vs. OCP therapy on the PCOS reproductive phenotype

Outcome Description:

The investigators will wait until study is completed to review change in Body Mass Index, Free Androgen Index and Proinsulin on these subjects when study is completed

Outcome Time Frame:

When the study and data analysis is completed in 5 Years

Safety Issue:

No

Principal Investigator

Richard S Legro, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Authority:

United States: Institutional Review Board

Study ID:

27184

NCT ID:

NCT00704912

Start Date:

September 2008

Completion Date:

March 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • Polycystic Ovary Syndrome
  • Hyperandrogenism

Name

Location
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
University of Pennsylvania, Department of Obstetrics and Gynecology Philadelphia, Pennsylvania  19104