Infertility, IVF, Preimplantation Diagnosis
Conditions
Brief 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.
Interventions
DRUGGnRh antagonist
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
DRUGMicronized progesterone
Micronized progesterone protocol to avoid LH surge in COS, from stimulation day 1 and continuing until ovulation triggering.
Sponsors
Fundacion Dexeus
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
36 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Infertile patients * Age 36-40 years old * BMI 18-30 kg/m2 * Undergoing preimplantation genetic screening cycles * Planned to undergo at least two treatment cycles, to accumulate embryos to increase the chance of obtaining euploid embryos for transfer * Willing to participate in the study
Exclusion criteria
* Age\> 41 * Severe male factor requiring TESE (testicular sperm extraction) * Low ovarian reserve (AMH \< 1.2 ng/ml) * Administration of any other drug potentially interfering with the treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of euploid embryos as compared between the 2 ovarian stimulation cycles | 15-45 days following oocyte retrieval procedure | Number of euploid embryos between oocytes received from the antagonist GnRh protocol or the micronized progesterone protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endocrine profile at specific intervals | 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) | To evaluate the difference in the mean serum estradiol (E2) levels (measured in pg/mL) at the predefined intervals treatment days. |
| Duration of stimulation | 9-20 days from initiation of ovarian stimulation | Total days of ovarian stimulation. The outcome will be evaluated on the of final oocyte maturation. |
| Incidence of premature LH rise | 9-20 days from initiation of ovarian stimulation | — |
| Total dose of gonadotropins | 9-20 days from initiation of ovarian stimulation | Total units of recombinant FSH. The outcome will be evaluated on the day of final oocyte maturation. |
| Ultrasound ovarian follicles diameter measurement | 9-20 days from initiation of ovarian stimulation | During the regular follicular scan, two diameters of each ovarian follicle will be recorded: the maximum diameters in the transverse and longitudinal scan planes. |
| Fertilization rate | 1 day after oocyte retrieval | The outcome will be evaluated the day after the of oocyte retrieval |
| Number of mature oocytes | 9-20 days from initiation of ovarian stimulation | The outcome will be evaluated on the day of oocyte retrieval |
Countries
Spain
Outcome results
None listed