Phase 2
Completed N=149
Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women
Source: ClinicalTrials.gov NCT00704912 ↗Enrolled (actual)
149
Serious AEs
2.7%
Results posted
Dec 2015
Primary outcomePrimary: Live Birth Rate — 13; 5; 12 participants — p=0.06
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Live Birth Rate |
13; 5; 12 | 0.06 |
| SECONDARY Ovulation Rate |
82; 71; 94 | 0.06 |
| SECONDARY Change in Weight |
-6.2; -1.1; -6.1 | <.0001 sig |
| SECONDARY Prevalence of Metabolic Syndrome |
18; 14; 21; 18; 21; 16 | 0.60 |
Eligibility Criteria
Couples 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 one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years, or confirmation of a intrauterine pregnancy within the past 2 years.
- No previous sterilization procedures(vasectomy, tubal ligation) that have been reversed.
- Wanting to seek pregnancy.
Inclusion Criteria
- Chronic anovulation or oligomenorrhea defined as intermenstrual periods of >= 45 days or a total of =50 ng/dL.
- Hirsutism determined by a modified Ferriman-Gallwey Score >8.
- PCO on ultrasound (12 or more follicles measuring 2-9 mm in diameter).
- BMI >=27 to 30 ng/mL.
- Patients with known 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone (17-OHP) level 20 mIU/mL.
- Patients with uncorrected thyroid disease (TSH 4.5 mIU/ML).
- Patients diagnosed with Type1 or Type II diabetes.
- Patients with liver disease defined as AST or ALT >2 times normal or total bilirubin >2.5 mg/dL.
- Patients with renal disease defined as BUN >30 mg/dL or serum creatinine >1.4 mg/dL.
- Patients with significant anemia (Hemoglobin =150 mm Hg or average diastolic >=100 mm Hg on three measurements obtained 5 minutes apart. If treated, average systolic blood pressure >= 140 mm Hg or average diastolic >= 90 mm Hg.
- Patients with medical conditions that represent contraindications to orlistat, OCP, clomiphene, and/or pregnancy.
- Patients currently participating in lifestyle intervention program (Weight Watchers, Atkins Diet, Curves) or lost more than 5% body weight within the last 6 months.
Data sourced from ClinicalTrials.gov (NCT00704912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.