Luteal Phase FSH in the IVF Poor Responder

Inclusion criteria

• Infertile women planning to undergo IVF
• Poor ovarian response in most-recent previous IVF cycle within the past 18 months as defined by the following criteria:

A) <5 dominant follicles day of hCG, B) <5 oocytes retrieved, or C) cancellation of a previous IVF cycle due to poor response to ovulation stimulation.

• Aged 20-42 (inclusive) at the time of randomization
• Presence of both ovaries
• Normal pap smear within past three years
• At least 45 days after the last IVF cycle
• Be willing and able to comply with the protocol for the duration of the study
• Have given written informed consent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

Exclusion criteria

• Clinically significant systemic disease
• Current regular cigarette smoking by patient report
• Known to be positive for Human Immunodeficiency Virus
• 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
• Abnormal, undiagnosed gynecological bleeding
• Known allergy or hypersensitivity to human gonadotropin preparations
• Simultaneous participation in another investigational drug or device trial
• 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
• 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