Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

Completed

• Conditions: Ovarian Hyperstimulation Syndrome

• Registration Number: NCT00835523
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months	12 months after recruitment

Secondary Outcome Measures

Name	Time	Method
ongoing pregnancy rate/frozen-thawed ET	12 months after recruitment
Ongoing pregnancy rate/first frozen-thawed ET	12 months after recruitment
time to pregnancy in weeks	12 months after recruitment
incidence of OHSS III°	12 months after recruitment
number of cumulus-oocyte-complexes	12 months after recruitment
fertilization rate (number COCs/number of 2 PN oocytes	12 months after recruitment
survival rate (number of vital embryos/number of frozen 2 PN oocytes	12 months after recruitment

Trial Locations

Locations (10)

Department of Obestrics and Gynecology, University Bonn; 🇩🇪 Bonn, Germany

Deutsche Klinik Bad Münder; 🇩🇪 Bad Münder, Germany

IVF-Augsburg; 🇩🇪 Augsburg, Germany

University Centre for Reproductive Medicine Franken; 🇩🇪 Erlangen, Germany

Kinderwunschpraxis; 🇩🇪 Tübingen, Germany

Department of Obestrics and Gynecology, University Wuerzburg; 🇩🇪 Wuerzburg, Germany

Interdisziplinäres Kinderwunschzentrum; 🇩🇪 Duesseldorf, Germany

Department of Obestrics and Gynecology, University Magdeburg; 🇩🇪 Magdeburg, Germany

Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck; 🇩🇪 Luebeck, Germany

Department of Obestrics and Gynecology, University Cologne; 🇩🇪 Cologne, Germany