Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)
Condition: In Vitro Fertilization
Intervention: Corifollitropin alfa; FSH; GnRH antagonist; (rec)hCG; Progesterone
Intervention description: Corifollitropin alfa 150 µg administered as a single subcutaneous dose.; FSH administerd subcutaneously at a dose not to exceed 225 IU/day.; GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.; (rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.; Progesterone administered vaginally at a dose of at least 600 mg/day.
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 682.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: Infertility; Pharmacological effects of drugs; Hormones, Hormone Substitutes and Hormone Antagonists; Pharmacological Actions; Multi-center

Summary:

      The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin
      alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated
      COS cycles using a multiple dose GnRH antagonist protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of couples with an indication for COS and IVF or ICSI;

          -  >=18 and <=39 years of age at the time of signing informed consent;

          -  Body weight > 60 kg and body mass index (BMI) >=18 and <=29 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 history of ovarian hyperstimulation syndrome
             (OHSS);

          -  History of or current polycystic ovary syndrome (PCOS);

          -  More than 20 basal antral follicles (size: <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 hydrosalpinx (visible on USS);

          -  More than three unsuccessful COS cycles since the last established ongoing pregnancy
             (if applicable);

          -  History of non- or low ovarian response to FSH/human menopausal gonadotrophin (hMG)
             treatment;

          -  FSH > 12 IU/L or luteinizing hormone (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, including abnormal cervical smear (Papanicolaou [PAP]>=III, cervical
             intraepithelial neoplasia [CIN]>=1);

          -  Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
             undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH antagonists
             (e.g. hypersensitivity, pregnancy/lactation);

          -  Recent history of or current epilepsy, human immunodeficiency virus (HIV) infection,
             thrombophilia, diabetes or cardiovascular, gastro-intestinal, hepatic, renal, or
             pulmonary disease;

          -  Abnormal karyotyping of the participant or her partner (if karyotyping is performed);

          -  History or presence of alcohol or drug abuse within 12 months prior to signing
             informed consent;

          -  Previous use of corifollitropin alfa;

          -  Use of hormonal preparations within 1 month prior to screening;

          -  Administration of investigational drugs within three months prior to signing informed
             consent.