Frozen Embryo Transfer With GnRH-antagonist Trial

What Was Tested

The trial (phase 4) is built around Cetrorelix.

These embryos are then transferred into the womb of the patient with the hope of a resulting pregnancy and live birth.

Embryos can also be cryopreserved (frozen) and stored, and then later replaced in a cycle called frozen embryo transfer (FET).

It had two arms (groups): No GnRH antaogonist (experimental) and Standard GnRH antoagonist (active comparator).

The registry classes the interventions as drug.

Who Took Part

300 planned participants were the target.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Willing and able to give informed consent for participation in the study. Planning to undergo medicated FET. Blastocyst embryo in storage available for transfer.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: previously randomised into the trial; A history of 3 or more consecutive implantation failures (after fresh or frozen embryo transfer); A history of recurrent miscarriage (3 or more consecutive miscarriages).

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 2018-12-13 with completion listed for 2021-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Live Birth Rate (time frame: To treatment or pregnancy end (up to 9 months)).

It also tracked 1 secondary outcome, for example Cancellation rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cetrorelix in 300 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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