Back to resultsAdministration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
Primary Purpose
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cetrotide
Sponsored by
About this trial
This is an interventional trial for Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
Eligibility Criteria
Inclusion Criteria:30 women undergoing IVF cycle with GnRH Antagonist protocol under 35 years old.
E2 higher than 3000 pg/ml. -
Exclusion Criteria: 3 or more failed fresh IVF cycles.
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Sites / Locations
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Cetrotide
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01109888
Brief Title
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
Official Title
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian During Controlled Ovarian Stimulation(COH) for In Vitro Fertilisation(IVF)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Withdrawn
Why Stopped
there was no percipitant enrolled
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Coasting is one of the means to reduce the risk of OHSS for patients at risk for severe OHSS. During coasting gonadotrophin administration is withheld until serum E2 levels drop to a range considered safe. Prolonged coasting reduces the chance for implantation and pregnancy. The aim of the study is to explore whether an increased dose of GnRH Antagonist will shorten the coasting period without an adverse effect on cycle outcome.
Detailed Description
30 patients undergoing IVF using a GnRH antagonist protocol that present with a high response to gonadotrophin stimulation, will be randomized into one of two groups: group A - withdrawal of gonadotrophin support and continue a daily dose of 0.25 mg of the GnRH antagonist. group B - withdrawal of gonadotrophin support and continue a double daily dose of 0.5 mg of the GnRH antagonist.
The main outcome measures will be the duration of coasting (days)and the rate of serum E2 drop (%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
7. Study Design
Study Phase
Phase 1, Phase 2
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cetrotide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cetrotide
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Eligibility Criteria
Inclusion Criteria:30 women undergoing IVF cycle with GnRH Antagonist protocol under 35 years old.
E2 higher than 3000 pg/ml. -
Exclusion Criteria: 3 or more failed fresh IVF cycles.
-
12. IPD Sharing Statement
Learn more about this trial
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
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