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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
Institut Universitari Dexeus
Barcelona, Catalonia, Spain
Number of euploid embryos as compared between the 2 ovarian stimulation cycles
Number of euploid embryos between oocytes received from the antagonist GnRh protocol or the micronized progesterone protocol.
Time frame: 15-45 days following oocyte retrieval procedure
Endocrine profile at specific intervals
To evaluate the difference in the mean serum estradiol (E2) levels (measured in pg/mL) at the predefined intervals treatment days.
Time frame: Stimulation day 0, day 6, day 8, day of final oocyte maturation and day +1 after oocyte maturation (actual day may vary between 9-15)
Endocrine profile at specific intervals
To evaluate the difference in the mean serum follicle stimulating hormone levels (FSH, measured in IU/mL) at the predefined intervals treatment days.
Time frame: Stimulation day 0, day 6, day 8, day of final oocyte maturation and day +1 after oocyte maturation (actual day may vary between 9-15)
Endocrine profile at specific intervals
To evaluate the difference in the mean serum progesterone levels (measured in ng/mL) at the predefined intervals treatment days.
Time frame: Stimulation day 0, day 6, day 8, day of final oocyte maturation and day +1 after oocyte maturation (actual day may vary between 9-15)
Duration of stimulation
Total days of ovarian stimulation. The outcome will be evaluated on the of final oocyte maturation.
Time frame: 9-20 days from initiation of ovarian stimulation
Incidence of premature LH rise
Time frame: 9-20 days from initiation of ovarian stimulation
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Total dose of gonadotropins
Total units of recombinant FSH. The outcome will be evaluated on the day of final oocyte maturation.
Time frame: 9-20 days from initiation of ovarian stimulation
Number of mature oocytes
The outcome will be evaluated on the day of oocyte retrieval
Time frame: 9-20 days from initiation of ovarian stimulation
Ultrasound ovarian follicles diameter measurement
During the regular follicular scan, two diameters of each ovarian follicle will be recorded: the maximum diameters in the transverse and longitudinal scan planes.
Time frame: 9-20 days from initiation of ovarian stimulation
Fertilization rate
The outcome will be evaluated the day after the of oocyte retrieval
Time frame: 1 day after oocyte retrieval