Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
Condition: Infertility; IVF; Preimplantation Diagnosis
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To examine whether the number of euploid embryos following ovarian stimulation with
      micronized progesterone is equivalent as compared with the number of embryos after ovarian
      stimulation with the use of a GnRH antagonist in patients undergoing ovarian stimulation for
      IVF or intracytoplasmatic sperm injection (ICSI).
    

Detailed description: 
      The pre-ovulatory surges of GnRH and LH are activated by increased concentrations of
      circulating estradiol, but ovulation is blocked when progesterone concentrations are
      elevated, due to a central inhibition of the GnRH surge. Although traditionally GnRH has been
      traditionally considered the drug of choice to control endogenous LH in controlled ovarian
      stimulation (COS) cycles, recently, micronized progesterone has been shown to be an effective
      oral alternative for preventing premature LH surges during COS in women undergoing IVF/ICSI
      treatments, with excellent results, whereas their safety during pregnancy is
      well-established. This novel protocol, has several advantages (good tolerance, user
      convenience, and cost reduction), that are very attractive when it comes to establishing a
      convenient user regimen in combination with a ''freeze all'' strategy. However, the
      comparative efficacy of this novel protocol with the more universal use of GnRH-antagonist
      protocol for the treatment of IVF patients in terms of embryo ploidy has never been evaluated
      up to date. The current study aims, for the first time, to examine whether the number of
      euploid embryos following ovarian stimulation with micronized progesterone is equivalent as
      compared with the number of embryos after ovarian stimulation with the use of a GnRH
      antagonist in patients undergoing ovarian stimulation for IVF/ICSI.

      If efficacy would prove to be similar, with no impact on the chromosomal constitution of
      embryos, there will be obvious advantages for the preferential use of micronized progesterone
      over the antagonist protocol: oral administration is preferred over subcutaneous injection,
      and total cost of medication would be lower. This would be particularly interesting for the
      future in all "freeze all" protocols such as women undergoing ovarian stimulation for
      fertility preservation, preimplantation genetic screening and oocyte donation programs.
    

Intervention name(s): GnRh antagonist; Micronized progesterone
Intervention type(s): Drug; Drug
Intervention description(s): In the antagonist cycle, LH suppression will be accomplished by subcutaneous (SC) injections of 0.25 mg of Cetrorelix or Ganirelix starting in the presence of follicles >14mm or E2 levels >400 pg/ml and continuing until ovulation triggering to avoid LH surge in COS; Micronized progesterone protocol to avoid LH surge in COS, from stimulation day 1 and continuing until ovulation triggering.
Other intervention name(s): Cetrorelix or Ganirelix; Utrogestan
Intervention MeSH terms: Cetrorelix; Progesterone; Ganirelix
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 44 women undergoing IVF treatments due to infertility, will be asked to participate in a trial in which they will undergo 2 ovarian stimulation protocols with recombinant follicle stimulating hormone (rFSH): the first one using a flexible antagonist protocol to suppress the endogenous LH rise and the second using oral micronized progesterone 200 mg/day from day 1 of stimulation.
Masking: None (Open Label)
Primary purpose: Treatment