Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

NCT ID: NCT00835523

Last Updated: 2012-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-07-31

Brief Summary

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The aim of the study is to explore the concept of GnRH-agonist triggering in combination with elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting. The question asked is: "Does GnRH-agonist triggering and cryopreservation work", in terms of efficacy and safety, when applied to a larger cohort of patients, and by a number of different centres with different clinical routines.

Detailed Description

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Conditions

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Ovarian Hyperstimulation Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OHSS risk

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Indication for IVF with ICSI
* Age \< 40 years
* \< 4 failed previous IVF attempts with embryo transfer
* ovarian stimulation with GnRH-antagonist and gonadotrophins
* \>20 follicles \>11 mm in mean diameter or E2 \>4500 pg/ml on the day , on which it was planned to administer hCG
* willing to participate and able to consent
* patient has not previously received GnRH-agonist as a trigger of final oocyte maturation

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Georg Griesinger

Director of Department of Reproductive Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg Griesinger, PD Dr. med.

Role: STUDY_CHAIR

Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck

Locations

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IVF-Augsburg

Augsburg, , Germany

Site Status

Deutsche Klinik Bad Münder

Bad Münder am Deister, , Germany

Site Status

Department of Obestrics and Gynecology, University Bonn

Bonn, , Germany

Site Status

Department of Obestrics and Gynecology, University Cologne

Cologne, , Germany

Site Status

Interdisziplinäres Kinderwunschzentrum

Düsseldorf, , Germany

Site Status

University Centre for Reproductive Medicine Franken

Erlangen, , Germany

Site Status

Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck

Lübeck, , Germany

Site Status

Department of Obestrics and Gynecology, University Magdeburg

Magdeburg, , Germany

Site Status

Kinderwunschpraxis

Tübingen, , Germany

Site Status

Department of Obestrics and Gynecology, University Wuerzburg

Würzburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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OHSS 2009

Identifier Type: -

Identifier Source: org_study_id

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