Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome

Phase 2

Completed

• Conditions: Assisted Reproduction
• Interventions: Drug: Cetrorelix

• Registration Number: NCT02784457
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-24
• Last Update Submitted: 2016-05-24
• Study First Posted: 2016-05-27
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRHant	Cetrorelix	women who received GnRH antagonist

Primary Outcome Measures

Name	Time	Method
Number of women who needed culdocentesis or paracentesis of the ascitic fluid	within 2 weeks of onset

Secondary Outcome Measures

Name	Time	Method
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
Time to regression of large ovarian size	within 4 weeks of onset of symptoms