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Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)

Sponsor
Wolfson Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01109888
Collaborator
(none)
0
Enrollment
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 (%).

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
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)

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cetrotide

Drug: Cetrotide

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female

    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.

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wolfson Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01109888
    Other Study ID Numbers:
    • 12101967
    First Posted:
    Apr 23, 2010
    Last Update Posted:
    Mar 30, 2016
    Last Verified:
    Apr 1, 2010
    Additional relevant MeSH terms:
    Ovarian Hyperstimulation Syndrome
    Syndrome
    Cetrorelix

    Study Results

    No Results Posted as of Mar 30, 2016