A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
Condition: In Vitro Fertilization
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa
      (Organon 36286) to induce multifollicular development for controlled ovarian stimulation
      using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single
      injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in
      initiating multifollicular growth.
    

Detailed description: 
      This is a randomized, double-blind, active-controlled, non-inferiority clinical trial
      investigating the efficacy and safety of a new treatment regimen with Corifollitropin Alfa, a
      recombinant gonadotropin applied to initiate and sustain follicular stimulation in controlled
      ovarian stimulation for Assisted Reproductive Technology (ART). For this regimen,
      participants receive a single injection of Corifollitropin Alfa and one week later, treatment
      is continued with daily recFSH up to the day of triggering final oocyte maturation. In the
      reference group participants receive daily injections of recFSH up to the day of triggering
      final oocyte maturation. Non-inferiority in ongoing pregnancy rates (assessed at least 10
      weeks after embryo transfer) will be the primary endpoint for this trial. The number of
      oocytes retrieved will be analyzed as co-primary endpoint.
    

Intervention name(s): Corifollitropin alfa; RecFSH / Follitropin beta (Days 1 to 7); Placebo Corifollitropin alfa; Placebo RecFSH / follitropin beta; RecFSH / Follitropin beta (Days 8 to hCG); Ganirelix; hCG; Progesterone
Intervention type(s): Drug; Biological; Drug; Drug; Biological; Drug; Biological; Biological
Intervention description(s): On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.; Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.; Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.; Identical ready-for-use solution, but without the active ingedient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.; From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.; On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG; When 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP; On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
Other intervention name(s): MK-8962; SCH 900962; Org 36286; Puregon / Follistim AQ Cartridge; Puregon / Follistim AQ Cartridge; Orgalutran/ Ganirelix Acetate Injection; Pregnyl / urinary hCG
Intervention MeSH terms: Progesterone; Follicle Stimulating Hormone; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Infertility; Pharmacological effect of drugs; Hormones; Hormone substitutes and hormone antagonists; Pharmacological actions; Randomized; Multi-center; Multi-national; Double-blind; Active-controlled; Non-inferiority