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
Intervention: 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 description: 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.
Intervention MeSH terms: Progesterone; Follicle Stimulating Hormone; Ganirelix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1509.0
Sex: Female
Minimum age: 18 Years
Maximum age: 36 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of couples with an indication for Controlled Ovarian Stimulation (COS) and
             in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI);

          -  >=18 and <=36 years of age at the time of signing informed consent;

          -  Body weight > 60 and <=90 kg and body mass index (BMI) >=18 and <=32 kg/m^2;

          -  Normal menstrual cycle length: 24-35 days;

          -  Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is
             allowed);

          -  Willing and able to sign informed consent.

        Exclusion Criteria:

          -  History of/or any current (treated) endocrine abnormality;

          -  History of ovarian hyper-response or ovarian hyperstimulation syndrome

        (OHSS);

          -  History of/or current polycystic ovary syndrome (PCOS);

          -  More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on
             ultrasound scan (USS) in the early follicular phase (menstrual cycle day 2-5);

          -  Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm;
             visible on USS);

          -  Presence of unilateral or bilateral hydrosalphinx (visible on USS);

          -  Presence of any clinically relevant pathology affecting the uterine cavity or fibroids
             >=5 cm;

          -  More than three unsuccessful IVF cycles since the last established ongoing pregnancy
             (if applicable);

          -  History of non- or low ovarian response to FSH/ human menopausal gonadotropin (hMG)
             treatment;

          -  History of recurrent miscarriage (3 or more, even when unexplained);

          -  FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during
             the early follicular phase: menstrual cycle day 2-5);

          -  Any clinically relevant abnormal laboratory value based on a sample taken during the
             screening phase;

          -  Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
             undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);

          -  Recent history of/or current epilepsy, human immunodeficiency virus (HIV) infection,
             diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;

          -  Abnormal karyotyping of the patient or her partner (if karyotyping is performed);

          -  Smoking more than 5 cigarettes per day;

          -  History or presence of alcohol or drug abuse within 12 months prior to signing
             informed consent;

          -  Previous use of Org 36286;

          -  Use of hormonal preparations within 1 month prior to randomization;

          -  Hypersensitivity to any of the concomitant medication prescribed as part of the
             treatment regimen in this protocol;

          -  Administration of investigational drugs within three months prior to signing informed
             consent.