Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF

What Was Tested

The trial (not phased) is built around Cetrorelix.

Ovarian stimulation was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with luteinizing hormone activity.

It had two arms (groups): Generic cetrorelix acetate (experimental) and Reference cetrorelix acetate (active comparator).

The registry classes the interventions as drug.

Who Took Part

1338 planned participants were the target.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening procedures and clinical study. All subjects should sign the informed consent form. With flexible GnRH antagonist.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: subjects could not enter the study if they meet any one of the following criteria; preimplantation genetic testing (pgt); untreated hydrosalpinges, moderate or severe endometriosis, recurrent spontaneous miscarriage, endometrial pathology, uterine malformations, etc.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

Blinding on both sides kept the participants and researchers unaware of who received Cetrorelix.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-02-27 with completion listed for 2025-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cumulative live birth rate (time frame: Through study completion, an average of 18 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 1338 people.

With 1338 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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