Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles. (Prog_STIM)

Institut Universitari Dexeus

Status: Completed

Conditions: Preimplantation Diagnosis; IVF; Infertility

Treatments: Drug: Micronized progesterone; Drug: GnRh antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT04108039

FSD-PRG-2019-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 36 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

GnRH antagonist

Active Comparator group

Description:

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.

Treatment:

Drug: GnRh antagonist

Micronized progesterone

Experimental group

Description:

In the progesterone cycle, endogenous LH suppression will be accomplished by oral administration of micronized progesterone (200 mg) once a day at bed time, from stimulation day 1 and continuing until ovulation triggering.

Treatment:

Drug: Micronized progesterone