Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women

Exclusion Criteria

• •Current pregnancy.
• •Patients on oral contraceptives, depo progestins, or hormonal implants.
• •Patients with hyperprolactinemia defined as two prolactin levels at least one week apart \>30 ng/mL.
• •Patients with known 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone (17-OHP) level \<2 ng/mL and ACTH stimulation test as needed, or other enzyme deficiency.
• •Patients with menopausal FSH levels \>20 mIU/mL.
• •Patients with uncorrected thyroid disease (TSH \<0.45 mIU/ML or \>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 \<10 mg/dL).
• •Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
• •Patients with known heart disease that is likely to be exacerbated by pregnancy.
• •Patients with a history of , or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal PAP smear or reassuring colposcopy based on current ACOG guidelines will be required.
• •Patient with current history of alcohol abuse.
• •Patients enrolled simultaneously into other investigative studies.
• •Patients taking other medications know to affect reproductive function or metabolism.
• •Patients with a suspected adrenal or ovarian tumor secreting androgens.
• •Patients with suspected Cushing's syndrome.
• •Patients who have undergone a bariatric surgery procedure in the recent past (\<12 months).
• •Patients with untreated poorly controlled hypertension defined as systolic blood pressure \>=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.