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Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome
Plain-language guide to NCT02784457: phase 2 randomized trial of Cetrorelix, 84 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02784457
- Phase
- phase 2
- Status
- completed
- Start
- 2014-06
- Completion (planned or actual)
- 2015-12
- Participants
- 84 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Assisted Reproduction
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Cetrorelix.
It had two arms (groups): GnRHant (active comparator) and Control (no intervention).
Women who received GnRH antagonist.
Women who did not receive GnRH antagonist.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 84 actual participants took part.
It was open to women only aged from 20 years up to 42 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women who develop early-onset severe ovarian hyperstimulation syndrome after controlled ovarian stimulation using long GnRH agonist protocol and hCG for triggering ovulation.
The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: women on short or antagonist protocols; women who received gnrh agonist for triggering ovulation; women who had embryo transfer.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
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.
Nothing was hidden in this open-label Cetrorelix study: the participants and staff both knew the treatment.
It started in 2014-06 with completion listed for 2015-12.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of women who needed culdocentesis or paracentesis of the ascitic fluid (time frame: within 2 weeks of onset).
It also tracked 3 secondary outcomes, for example Number of women who needed hospitalization, Time to regression of nausea/vomiting and Time to regression of large ovarian size.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Cetrorelix in 84 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.
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.