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

What Was Tested

The trial (not phased) is built around Cetrorelix.

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).

It had two arms (groups): GnRH antagonist (active comparator) and Micronized progesterone (experimental).

The registry classes the interventions as drug.

More on the Plan

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 Took Part

44 actual participants took part.

It was open to women only aged from 36 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 36-40 years old. BMI 18-30 kg/m2. Undergoing preimplantation genetic screening cycles. Willing to participate in the study.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: age\> 41; severe male factor requiring tese (testicular sperm extraction); low ovarian reserve (amh \< 1.2 ng/ml).

How the Study Was Run

The set-up was non-randomized, sequential and open-label.

Everyone knew when Cetrorelix was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-09-25 with completion listed for 2022-01-15.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of euploid embryos as compared between the 2 ovarian stimulation cycles (time frame: 15-45 days following oocyte retrieval procedure).

It also tracked 9 secondary outcomes, for example Endocrine profile at specific intervals, Endocrine profile at specific intervals, Endocrine profile at specific intervals, Duration of stimulation, Incidence of premature LH rise and Number of mature oocytes.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cetrorelix in 44 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, all human trials.