Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      In an opened randomized study of women undergoing in vitro fertilization with expected
      suboptimal response to controlled ovarian stimulation (Poseidon Group 2b) investigators will
      examine clinical efficacy and safety of two stimulation protocols: Corifollitropin alfa
      (Elonva) in combination with menotropin (Merional) versus Follitropin alfa and lutropin alfa
      (Pergoveris).
    

Detailed description: 
      Patients, found eligible for the study, will be randomized (envelope method) into two arms in
      1:1 ratio at the start of stimulation (menstrual cycle day 2-3, randomization day): Arm A -
      ovarian stimulation with Corifollitropin alfa in combination with menotropin; Arm B - ovarian
      stimulation with Follitropin alfa and lutropin alfa.

      At the first day of controlled ovarian stimulation (COS) participants in the first group will
      receive a single injection of Corifollitropin alfa 150 mcg followed by daily menotropin
      administration at the dose of 150 international unit (IU) from stimulation day 1 to day 7 and
      at the dose of 300 IU from day 8 up to the end of stimulation.

      Ovarian stimulation in group B will be performed with daily 300 IU of Follitropin alfa and
      lutropin alfa starting on menstrual cycle day 2-3.

      For all subjects, a fixed dose of gonadotropin-releasing hormone (GnRH) antagonist will be
      injected daily as soon as one of the follicles reaches the ≥14 mm diameter and stopped one
      day before oocyte pick up (OPU); ovulatory dose of human chorionic gonadotropin (hCG) could
      be administered when at least one follicle reaches 16.5 mm in diameter.

      Retrieved oocytes following fertilization (conventional IVF or ICSI) will be cultured to
      morula or blastocyst stage followed by ultrasound guided single or double embryo transfer (ET
      day, performed 4-5 days after OPU).
    

Intervention name(s): Corifollitropin alfa and menotropin; Follitropin alfa and lutropin alfa
Intervention type(s): Drug; Drug
Intervention description(s): Procedure: Ovarian stimulation is performed by the combination of a single Corifollitropin alfa 150 mcg injection on menstrual cycle day 2-3 and daily menotropin administration at the dose of 150 IU from stimulation day 1-7 and at the dose of 300 IU from day 8 to the end of stimulation (maximal dose adjustment to 450 IU).
Other interventions: conventional GnRH antagonist protocol and in vitro fertilization (IVF/ICSI) cycle; Procedure: Ovarian stimulation is performed with daily 300 IU of Follitropin alfa and lutropin alfa starting on menstrual cycle day 2-3. Maximal allowed dose adjustment is 450 IU daily.
Other interventions: conventional GnRH antagonist protocol and in vitro fertilization (IVF/ICSI) cycle.
Other intervention name(s): Elonva, Merional; Pergoveris
Intervention MeSH terms: Menotropins; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: suboptimal response; Corifollitropin alfa; IVF; Ovarian stimulation