Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
Condition: Infertility
MeSH terms: Infertility
Intervention: SCH 900962 / Corifollitropin alfa / Org 36286; RecFSH / follitropin beta; Placebo for SCH 900962; Placebo for recFSH
Intervention description: SCH 900962 will be provided as ready-for-use prefilled syringes containing 150 μg corifollitropin alfa per 0.5 mL. On day 2 or 3 of the menstrual cycle, a single dose of 150 μg corifollitropin alfa will be administered by subcutaneous injection in the abdominal wall in the morning.; RecFSH will be provided as a ready-for-use solution in 900 IU cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of recFSH will be done in the morning by daily injections in the abdominal wall. A starting dose of 300 IU will be administered and fixed for at least 7 days.; Supplied as a pre-filled syringe containing an identical solution when
compared to SCH 900962, however without the active ingredient corifollitropin alfa. On Day 2 or 3 of the menstrual cycle (=Stimulation Day 1), a single dose of placebo SCH 900962 is to be administered in the morning by subcutaneous injection in the abdominal wall.; Supplied as identical ready-for-use solution, but without the active ingredient, in cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of placebo-recFSH will be done by daily injections in the abdominal wall in the morning for a period of 7 days.
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1424.0
Sex: Female
Minimum age: 35 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Reproductive Techniques, Assisted; Follicle Stimulating Hormone, Human; Fertilization In Vitro

Summary:

      The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is
      non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during
      the first week of ovarian stimulation in terms of the number of vital pregnancies (ie,
      presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days
      after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation
      (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent for trial P06029 as well as for
             the Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for the
             pharmacogenetic 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 within
             normal 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 early
             follicular 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 impair
             embryo implantation or pregnancy continuation.

          -  More than three unsuccessful COS cycles for IVF/ICSI since the last established
             ongoing 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 follicular
             phase.

          -  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 requiring
             regular treatment.

          -  Smoking or recently stopped smoking (ie, within the last 3 months prior to signing
             informed consent).

          -  A recent history or presence of alcohol or drug abuse.

          -  The participant or the sperm donor has known gene defects, genetic abnormalities, or
             abnormal karyotyping, relevant for the current indication or for the health of the
             offspring.

          -  Prior or concomitant medications disallowed by protocol.