Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)

Inclusion Criteria:

• Willing and able to provide written informed consent for trial P06029 as well as forthe Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for thepharmacogenetic analysis (if applicable).
• Female and >=35 to <=42 years of age with indication for COS and IVF/ICSI.
• Body weight ≥50.0 kg, body mass index (BMI) >=18.0 to <=32.0 kg/m2.
• Regular spontaneous menstrual cycle with variation not outside the 24-35 days.
• Ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed).
• Results of clinical laboratory tests, cervical smear, physical examination withinnormal limits or clinically acceptable to the investigator.
• Adhere to trial schedule.

Exclusion Criteria:

• A recent history of/or any current endocrine abnormality.
• A history of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS).
• A history of/or current polycystic ovary syndrome.
• More than 20 basal antral follicles <11 mm (both ovaries combined) in the earlyfollicular phase.
• Less than 2 ovaries or any other ovarian abnormality.
• Unilateral or bilateral hydrosalpinx.
• Intrauterine fibroids ≥5 cm or any clinically relevant pathology, which could impairembryo implantation or pregnancy continuation.
• More than three unsuccessful COS cycles for IVF/ICSI since the last establishedongoing pregnancy (if applicable).
• A history of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG)treatment.
• A history of recurrent miscarriage.
• FSH >15.0 IU/L or luteinizing hormone (LH) >12.0 IU/L during the early follicularphase.
• Positive for human immunodeficiency virus (HIV) or Hepatitis B.
• Contraindications for the use of gonadotropins or gonadotropin releasing hormone (GnRH) antagonists.
• A recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular,gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiringregular treatment.
• Smoking or recently stopped smoking (ie, within the last 3 months prior to signinginformed consent).
• A recent history or presence of alcohol or drug abuse.
• The participant or the sperm donor has known gene defects, genetic abnormalities, orabnormal karyotyping, relevant for the current indication or for the health of theoffspring.
• Prior or concomitant medications disallowed by protocol.