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Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF

Plain-language guide to NCT03680053: not phased randomized trial of Cetrorelix, 220 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03680053
Phase
not phased
Status
terminated early
Start
2020-04-10
Completion (planned or actual)
2025-05-10
Participants
220 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Infertility; ART
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Cetrorelix.

A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable with the GnRH antagonist protocol for patients undergoing IVF?

Design This is a randomized controlled trial.

Research plan Population: Infertile women who have medical indication for IVF will be recruited for study if they fulfil the selection criteria.

It had two arms (groups): PPOS group (experimental) and Antagonist group (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 220 actual participants took part.

It was open to women only aged from 20 years up to 43 years.

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

Examples of who could join: Age of women \<43 years at the time of ovarian stimulation for IVF. Antral follicle count (AFC) on day 2-5 of the period≥5.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: presence of a functional ovarian cyst with e2\>100 pg/ml; recipient of oocyte donation; undergoing preimplantation genetic testing.

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 2020-04-10 with completion listed for 2025-05-10.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: live birth rate of the first FET live birth rate of the first FET live birth rate (time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year).

It also tracked 17 secondary outcomes, for example Serum estradiol level, Serum progesterone level, Serum LH level, Serum FSH level, oocyte retrieved number and embryo number.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 220 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Cetrorelix: An FDA-approved GnRH antagonist used in IVF to prevent a premature LH surge.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.