To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
Condition: Infertility
MeSH terms: Infertility
Intervention: corifollitropin alfa (Org 36286); recFSH (follitropin beta); gonadatropin releasing hormone (GnRH) antagonist (ganirelix); human chorion gonadatropin (hCG); progesterone; placebo-recFSH (follitropin alfa); placebo-corifollitropin alfa; open-label recFSH
Intervention description: 100 µg corifollitropin alfa subcutaneous (SC) injection; 150 IU recFSH SC injection; GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day; hCG 5,000 IU or 10,000 IU administered SC; Progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.; Placebo-recFSH administered at the equivalent volume of 150 IU/day.; Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle.; Open-label recFSH administered up to a maximum dose of 200 IU/day.
Intervention MeSH terms: Hormones; 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: 397.0
Sex: Female
Minimum age: 18 Years
Maximum age: 36 Years
Healthy volunteers: No
Keywords: In vitro fertilization; Pharmacological effects of drugs; Hormones; Hormone Substitutes and Hormone Antagonists; Pharmacological Actions; Randomized; Multi-center; Multi-national; Double-blind; Active-controlled; Equivalence

Summary:

      Clinical trial objectives are to investigate the efficacy and safety of a single injection of
      100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for
      controlled ovarian stimulation (COS), using daily recFSH as a reference.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of couples with an indication for COS and IVF or ICSI;

          -  >=18 and <= 36 years of age at the time of signing informed consent;

          -  Body weight <= 60 kg and 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 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/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, 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.