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

Assisted Reproduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784457
• Other study ID #: DAT-01
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2016
• Last updated: May 24, 2016
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Assisted Reproduction
• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• Cetrorelix

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women who needed culdocentesis or paracentesis of the ascitic fluid		within 2 weeks of onset	No
Secondary	Number of women who needed hospitalization		within 2 weeks of onset of symptoms	No
Secondary	Time to regression of nausea/vomiting		within 2 weeks of onset of symptoms	No
Secondary	Time to regression of large ovarian size		within 4 weeks of onset of symptoms	No