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Completed

NCT Number: NCT04108039

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

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).

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Key information

Age range

36 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitari Dexeus

Barcelona, Catalonia, 08028, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GnRh antagonist

Drug

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

Other names: Cetrorelix or Ganirelix

Micronized progesterone

Drug

Micronized progesterone protocol to avoid LH surge in COS, from stimulation day 1 and continuing until ovulation triggering.

Other names: Utrogestan

Primary outcomes

  1. Number of euploid embryos as compared between the 2 ovarian stimulation cycles

    Time frame: 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 outcomes

  1. Endocrine profile at specific intervals

    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)

    To evaluate the difference in the mean serum estradiol (E2) levels (measured in pg/mL) at the predefined intervals treatment days.

  2. Endocrine profile at specific intervals

    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)

    To evaluate the difference in the mean serum follicle stimulating hormone levels (FSH, measured in IU/mL) at the predefined intervals treatment days.

  3. Endocrine profile at specific intervals

    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)

    To evaluate the difference in the mean serum progesterone levels (measured in ng/mL) at the predefined intervals treatment days.

  4. Duration of stimulation

    Time frame: 9-20 days from initiation of ovarian stimulation

    Total days of ovarian stimulation. The outcome will be evaluated on the of final oocyte maturation.

  5. Incidence of premature LH rise

    Time frame: 9-20 days from initiation of ovarian stimulation

  6. Total dose of gonadotropins

    Time frame: 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.

  7. Number of mature oocytes

    Time frame: 9-20 days from initiation of ovarian stimulation

    The outcome will be evaluated on the day of oocyte retrieval

  8. Ultrasound ovarian follicles diameter measurement

    Time frame: 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.

  9. Fertilization rate

    Time frame: 1 day after oocyte retrieval

    The outcome will be evaluated the day after the of oocyte retrieval

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Official study title

Suppression of Endogenous Luteinizing Hormone (LH) Surge With Progesterone vs GnRH Antagonist in Freeze-all IVF Cycles. A Prospective Equivalence Study With Repeated Ovarian Stimulation Cycles.

Acronym: Prog_STIM

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2019
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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