PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial

What Was Tested

In this phase 3 trial, researchers set out to test Cetrorelix.

By evaluating key clinical outcomes, including ovarian response, embryological parameters, and pregnancy rates, this study seeks to determine the relative advantages and limitations of each protocol.

It had two arms (groups): patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone (experimental) and patients that will receive the conventional GnRH antagonist. (active comparator).

The registry classes the interventions as drug.

More on the Plan

After being provided with sufficient time to decide whether to participate and the opportunity to ask questions, all participants were required to provide written informed consent before study inclusion.

Who Took Part

The registry lists 328 actual participants took part.

It was open to women only aged from 18 years up to 39 years.

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

Examples of who could join: • Women who had history of infertility for ≥1 year. Women whose age \<40 years old by the end of the study. Anti-Mullerian hormone \> 1.2 ng/ml. Antral follicle count ≥ 5.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: • age ≥ 40 years old; women who are diagnosed as polycystic ovarian syndrome; women with endometriosis stage 3 or 4.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Being open-label, the Cetrorelix study did not mask who received what.

It started in 2023-01-03 with completion listed for 2024-10-31.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): clinical pregnancy (time frame: 7 weeks of gestational age).

It also tracked 4 secondary outcomes, for example Incidence of moderate/severe OHSS, Number of metaphase 2 oocytes, number of 2 PN embryos and Biochemical pregnancy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cetrorelix in 328 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.