PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
Condition: Assisted Reproductive Techniques; Reproductive Technology, Assisted
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, multi-national, randomized, open-label comparative trial. After
      screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle.
      Down-regulation treatment will start within 2 months following the screening visit. The
      routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist
      treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be
      performed just before randomization and start of recombinant human follicle-stimulating
      hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative,
      the subject will be randomly assigned to one of the two treatment arms of the trial:

        -  GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5
           followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until
           required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be
           adjusted from stimulation Day 6 (increased or decreased) based upon the subject's
           ovarian response and according to the center's standard practice.

        -  Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required
           r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or
           decreased) based upon the subject's ovarian response and according to the center's
           standard practice.

      Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular
      development will be monitored according to the center's standard practice by ultrasound (US)
      and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one
      follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm). After
      this, a single injection of r-hCG will be administered in order to induce final oocyte
      maturation.

      At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally
      under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days
      after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET)
      and luteal support will be performed as per center's standard practice.

      A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant
      and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment
      (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take
      place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding
      pregnancy testing).
    


Intervention name(s): Gonal-f®; Pergoveris®; Pergoveris®; Recombinant human chorionic gonadotropin (r-hCG)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5).; Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.; Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.; 250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles >= 18 mm).
Other intervention name(s): Follitropin alfa; Ovidrel®; Ovitrelle®
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovulation Induction; Ovarian Stimulation; Reproductive Technique, Assisted; Assisted Reproductive Technics; Assisted Reproductive Technique; Reproductive Technology, Assisted