A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)
Condition: Ovulation Induction
MeSH terms: Infertility
Intervention: corifollitropin alfa; recombinant Follicle Stimulating Hormone (recFSH); human Chorion Gonadotropin (hCG); hCG Bolus injection
Intervention description: SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg).; Daily injections of SC recFSH (50 IU/75 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.; Daily injections of SC hCG (200 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.; Bolus injection of SC hCG was administered to induce final oocyte maturation if at least one follicle is ≥18 mm and no more than two follicles ≥15 mm are observed.
Intervention MeSH terms: Chorionic Gonadotropin; Hormones; Follicle Stimulating Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: Pharmacological effects of drugs; Hormones; Hormone Substitutes and Hormone Antagonists; Pharmacological Actions; Monofollicular growth; Randomized; Open-label; Active-controlled

Summary:

      The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286)
      regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily
      dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone
      (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm
      at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Oligomenorrhea (average cycle length ≥35 days and <6 months)

          -  Amenorrhea (average cycle length ≥6 months)

          -  Body Mass Index ≥18 and ≤30 kg/m^2

          -  Normal serum FSH levels and normal estradiol levels at screening

          -  Progestagen induced withdrawal bleeding

          -  Age ≥18 years and ≤39 years at the time of signing informed consent

          -  Willing and able to sign informed consent

        Exclusion Criteria:

          -  History of or current ovarian cysts or enlarged ovaries not related to polycystic
             ovarian syndrome (PCOS)

          -  History of or current tumors of the ovary, breast, uterus, pituitary or

        hypothalamus

          -  Less than 2 ovaries

          -  Undiagnosed vaginal bleeding

          -  Any ovarian and/or abdominal abnormality interfering with ultrasound

        examination

          -  Malformations of the sexual organs incompatible with pregnancy

          -  Pregnancy or lactation

          -  Abnormal serum endocrinology levels based on screening sample

          -  Any clinically relevant abnormal laboratory value based on screening sample

          -  Alcohol or drug abuse within the 12 months preceding signing of informed consent

          -  Hypersensitivity to any of the substances in corifollitropin alfa

          -  Hypersensitivity to hCG/ Puregon® or any of its components

          -  Previous use of corifollitropin alfa

          -  Use of any investigational drug during 90 days before screening