Luteal Phase FSH in the IVF Poor Responder

Exclusion Criteria

• •1. Clinically significant systemic disease
• •2. Current regular cigarette smoking by patient report
• •3. Known to be positive for Human Immunodeficiency Virus
• •4. Any medical condition which, in the judgment of the investigator and sponsor, may interfere with the absorption, distribution, metabolism or excretion of the medications used
• •5. Abnormal, undiagnosed gynecological bleeding
• •6. Known allergy or hypersensitivity to human gonadotropin preparations
• •7. Simultaneous participation in another investigational drug or device trial
• •8. Subject fails, in 2 separate menstrual cycle attempts, to have FSH ≤12.0 and an ultrasound exam within normal limits (per standard for IVF) at the Baseline Visit
• •9. For subjects randomized to the Luteal Phase Regimen, failure to ovulate in 2 separate menstrual cycle attempts, as evidenced by ovulation predictor kit, progesterone level, and /or visualization of corpus luteum cyst on an ovary by ultrasound exam at the Luteal Visit