Luteal Phase FSH in the IVF Poor Responder

• Number of follicles >10mm on day of human chorionic gonadotropin (hCG) administration; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
• Number of days of stimulation; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
• Estradiol level on the day of hCG administration; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
• Clinical pregnancy rate per transfer: defined as the presence of an intrauterine sac on transvaginal ultrasound; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
• Delivery rate per transfer; [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]
• Safety (incidence of ovarian torsion, severe risk of ovarian hyperstimulation syndrome, enlarging hemorrhagic cysts, and serious adverse events) [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]

• - Number of follicles >16mm on day of human chorionic gonadotropin (hCG) administration
• - Number of days of stimulation
• - Estradiol level on the day of hCG administration
• - Clinical pregnancy rate per transfer: defined as the presence of an intrauterine sac on transvaginal ultrasound
• - Delivery rate per transfer
• - Safety (incidence of ovarian torsion, severe risk of ovarian hyperstimulation syndrome, enlarging hemorrhagic cysts, and serious adverse events)

In vitro fertilization (IVF) is a common procedure used to assist couples who have difficulty conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from a woman's ovaries and fertilized with sperm in the laboratory. In order to maximize the number of oocytes that can be retrieved, a women undergoes ovarian stimulation with recombinant follicle stimulating hormone (FSH). Typically 6-20 oocytes are retrieved, but in some cases there is a limited response to the stimulation, producing a limited number of oocytes. This is called poor ovarian response.

This study is designed to objectively compare two treatment regimens currently advocated in clinical practice, but never compared directly. The purpose is to assess ovarian response to starting treatment at the end of the preceding cycle may increase the number of developing oocytes.

• Drug: follitropin beta
  Follitropin beta
• Drug: ganirelix acetate
  Ganirelix acetate

• Active Comparator: 1
  Follitropin beta
  Intervention: Drug: follitropin beta
• Active Comparator: 2
  Ganirelix acetate
  Intervention: Drug: ganirelix acetate

Inclusion Criteria:

1. Infertile women planning to undergo IVF

2. 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.

3. Aged 20-42 (inclusive) at the time of randomization
4. Presence of both ovaries
5. Normal pap smear within past three years
6. At least 45 days after the last IVF cycle
7. Be willing and able to comply with the protocol for the duration of the study
8. 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:

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