Clomiphene Citrate Plus Gonadotropins and GnRH Antagonist Versus Flexible GnRH Antagonist Protocol Versus Microdose GnRH Agonist Protocol in Poor Responders Undergoing IVF

Plain-language guide to NCT02201914: phase 4 randomized trial of Triptorelin and Cetrorelix, 250 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02201914
Phase: phase 4
Status: status unknown
Start: 2014-01
Completion (planned or actual): 2014-10
Participants: 250 (estimated)
Design: randomized, single-blind, treatment
Conditions studied: Poor Responders; IVF; Clomiphene Citrate; GnRH Agonist; GnRH Antagonist
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Triptorelin and Cetrorelix.

Poor ovarian response to stimulation in IVF cycles is a challenging and frustrating condition, due to its poor prognosis in terms of chances of pregnancy and live births.

Various ovarian stimulation regimens have been tried to overcome these obstacles.

It had three arms (groups): Clomiphene citrate (experimental), Daily FSH and LH plus Cetrorelix (experimental) and Triptorelin plus daily FSH and LH (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 250 planned participants were the target.

It was open to women only aged from 25 years up to 44 years.

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

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: body mass index \> 30; biochemical and ultrasound evidence of polycystic ovary syndrome; stage iii-iv endometriosis.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

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

In this single-blind Triptorelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2014-01 with completion listed for 2014-10.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Clinical pregnancy rate (time frame: Time Frame: until 12th gestational week).

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

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin and Cetrorelix in 250 people.

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

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

Our Notes on the Compounds

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

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

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.