Back to resultsGonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome
Primary Purpose
Assisted Reproduction
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cetrorelix
Sponsored by
About this trial
This is an interventional treatment trial for Assisted Reproduction
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
GnRHant
Control
Arm Description
women who received GnRH antagonist
women who did not receive GnRH antagonist
Outcomes
Primary Outcome Measures
Number of women who needed culdocentesis or paracentesis of the ascitic fluid
Secondary Outcome Measures
Number of women who needed hospitalization
Time to regression of nausea/vomiting
Time to regression of large ovarian size
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784457
Brief Title
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome
Official Title
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Assisted Reproduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GnRHant
Arm Type
Active Comparator
Arm Description
women who received GnRH antagonist
Arm Title
Control
Arm Type
No Intervention
Arm Description
women who did not receive GnRH antagonist
Intervention Type
Drug
Intervention Name(s)
Cetrorelix
Primary Outcome Measure Information:
Title
Number of women who needed culdocentesis or paracentesis of the ascitic fluid
Time Frame
within 2 weeks of onset
Secondary Outcome Measure Information:
Title
Number of women who needed hospitalization
Time Frame
within 2 weeks of onset of symptoms
Title
Time to regression of nausea/vomiting
Time Frame
within 2 weeks of onset of symptoms
Title
Time to regression of large ovarian size
Time Frame
within 4 weeks of onset of symptoms
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome
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