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Follicular Challenge Test to Predict Response to GnRH Agonist Triggering

Plain-language guide to NCT04973969: not phased interventional trial of Triptorelin, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04973969
Phase
not phased
Status
status unknown
Start
2021-01-01
Completion (planned or actual)
2022-04-30
Participants
100 (estimated)
Design
na, open label (everyone knows who gets what), diagnostic
Conditions studied
Infertility, Female
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Triptorelin.

The investigators aim to asses the possibility to predict the respone to ovulation triggering by the response to decapeptyl in the follicular phase of the same cycle.

It had 1 arm (groups): study group (other).

The registry classes the interventions as other.

More on the Plan

The investigators will use Decapeptyl on day 2 of menstruation followed by antagonist protocol.

Hormonal proflie including E2, P, LH, FSH will be measured.

LH surge and the rest of the hormonal profile will be compared to day after ovulation triggering.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to women only aged from 20 years up to 41 years.

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

Examples of who could join: Patients that undergo fertility preservation. Patients planned to freeze embryos due to PGT or surrogacy --patients at high risk for OHSS.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: poor ovarian response; known hypothalamic- pituitary dysfunction.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-01-01 with completion listed for 2022-04-30.

It ran at 1 site in Israel.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: The response to GnRH triggering (time frame: One treatment cycle (each cycle is 28 days) for each participant (up to 28 days)).

What This Means in Plain Language

Put simply, this is a not phased trial of Triptorelin in 100 people.

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

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

Our Notes on the Compound

Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.

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.