Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A

What Was Tested

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

This randomized trial aims to compare the euploid rate of blastocysts between PPOS and GnRH antagonist protocols in patients undergoing PGT-A.

Infertile women who have medical indication for PGT-A will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria.

Eligible women will be randomised into one of the two groups: Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 400 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) \>=5 on day 2-5 of the period. PGT-A indicated for advanced maternal age (\>=38 years), recurrent miscarriage (\>=2 consecutive miscarriage) and repeated implantation failure (\>=4 embryos replaced or \>=2 blastocysts replaced without success), recurrent foetal aneuploidy.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: presence of a functional ovarian cyst with e2\>100 pg/ml; recipient of oocyte donation; presence of hydrosalpinx or endometrial polyp which is not surgically treated.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cetrorelix group and the comparison group ran side by side rather than switching.

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 2020-06-10 with completion listed for 2024-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: euploidy rate (time frame: 1 month after oocyte retrieval).

It also tracked 15 secondary outcomes, for example number of mature oocytes, number and grading of blastocysts, positive serum hCG, clinical pregnancy, implantation rate and biochemical pregnancy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cetrorelix in 400 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.