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Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response
Plain-language guide to NCT04414761: phase 3 randomized trial of Cetrorelix, 784 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04414761
- Phase
- phase 3
- Status
- completed
- Start
- 2020-06-04
- Completion (planned or actual)
- 2022-10-10
- Participants
- 784 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- IVF; GnRH Antagonist; PPOS
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Cetrorelix.
It had two arms (groups): Antagonist group (active comparator) and PPOS group (experimental).
The registry classes the interventions as drug.
Who Took Part
784 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. The first IVF cycle. Antral follicle count (AFC) \>15 on day 2-5 of the period.
The full record lists 3 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.
The Cetrorelix group and the comparison group ran side by side rather than switching.
Being open-label, the Cetrorelix study did not mask who received what.
It started in 2020-06-04 with completion listed for 2022-10-10.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: live birth rate (time frame: deliveries ≥22 weeks gestation with heartbeat and breath).
It also tracked 16 secondary outcomes, for example positive serum hCG, clinical pregnancy, biochemical pregnancy, implantation rate, ongoing pregnancy and cumulative live birth.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Cetrorelix in 784 people.
With 784 participants it is a large trial for this field.
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.
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.