Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI

What Was Tested

The trial (phase 1, phase 2) is built around Cetrorelix.

Participants will: * Take either drospirenone (a daily pill) or the standard daily injection during their ovarian stimulation cycle, alongside their regular fertility hormone injections * Undergo egg retrieval, with all resulting embryos frozen (no fresh embryo transfer in this study) * Have a frozen embryo transferred in a later cycle * Complete two short questionnaires about their treatment experience - once before starting the injections/pills, and once after the stimulation phase ends * Be followed to determine if the embryo transfer results in a pregnancy.

It had two arms (groups): Drospirenone (experimental) and cetrorelix (active comparator).

50 cases will receive cetrorelix when the leading follicle reaches 14 mm till hCG trigger day.

The registry classes the interventions as drug.

More on the Plan

Single-center, open-label, 1:1 parallel-group pilot RCT, stratified by POSEIDON group.

Freeze-all is mandated in both arms by protocol (not patient choice).

No patient is offered fresh transfer in either arm, so no patient is excluded for requesting one; this is stated explicitly in the consent process so expectations are set at enrollment.

Both arms use a unified flexible start, triggered by leading follicle diameter reaching 14mm - not a fixed calendar day.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to women only aged from 20 years up to 42 years.

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

Examples of who could join: Spontaneous menstrual cycles (21-35 days). POSEIDON group recorded at enrollment (1-4) for stratified randomization and pre-specified subgroup description - corrects a known limitation of Bologna-only classification, which pools biologically distinct POR phenotypes. Indication for IVF/ICSI. Willing and able to undergo mandatory freeze-all/FET protocol. Signed informed consent, including explicit acknowledgment that fresh transfer is not offered in either study arm.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: contraindication to ovarian stimulation; known müllerian anomaly; uncontrolled systemic disease.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Cetrorelix group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Cetrorelix study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-08 with completion listed for 2027-10.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Metaphase II (Mii) oocytes (time frame: Day 0).

It also tracked 8 secondary outcomes, for example Number of oocytes retrieved, Fertilization rate 2 pronuclei (2PN), Quality of day-3 embryos, LH measure, Patient burden score and CPR ( clinical pregnancy rate).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Cetrorelix in 100 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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