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Clinical Trials/NCT02784457
NCT02784457
Completed
Phase 2

Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome - a Randomized Controlled Trial

Ain Shams University0 sites84 target enrollmentJune 2014
InterventionsCetrorelix

Overview

Phase
Phase 2
Intervention
Cetrorelix
Conditions
Assisted Reproduction
Sponsor
Ain Shams University
Enrollment
84
Primary Endpoint
Number of women who needed culdocentesis or paracentesis of the ascitic fluid
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe ovarian hyperstimulation syndrome and had cancelled embryo transfer

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Faris

Lecturer of Obstetrics and Gynecology

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Women who develop early-onset severe ovarian hyperstimulation syndrome after controlled ovarian stimulation using long GnRH agonist protocol and hCG for triggering ovulation.

Exclusion Criteria

  • Women on short or antagonist protocols.
  • Women who received GnRH agonist for triggering ovulation.
  • Women who had embryo transfer.

Arms & Interventions

GnRHant

women who received GnRH antagonist

Intervention: Cetrorelix

Outcomes

Primary Outcomes

Number of women who needed culdocentesis or paracentesis of the ascitic fluid

Time Frame: within 2 weeks of onset

Secondary Outcomes

  • Time to regression of large ovarian size(within 4 weeks of onset of symptoms)
  • Number of women who needed hospitalization(within 2 weeks of onset of symptoms)
  • Time to regression of nausea/vomiting(within 2 weeks of onset of symptoms)

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