Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

June 13, 2012 updated by: Georg Griesinger, University Hospital Schleswig-Holstein

OHSS Prevention by GnRH-agonist Triggering of Final Oocyte Maturation and Cryoperservation of All Two-pronucleate Oocytes in Women Undergoing Stimulation for IVF With Gonadotrophins and GnRH-analogues: a Prospective, Observational, Multicentric, Clinical Cohort Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86150
        • IVF-Augsburg
      • Bad Münder, Germany, 31848
        • Deutsche Klinik Bad Münder
      • Bonn, Germany, 53127
        • Department of Obestrics and Gynecology, University Bonn
      • Cologne, Germany, 50931
        • Department of Obestrics and Gynecology, University Cologne
      • Duesseldorf, Germany, 40219
        • Interdisziplinäres Kinderwunschzentrum
      • Erlangen, Germany, 91054
        • University Centre for Reproductive Medicine Franken
      • Luebeck, Germany, 23538
        • Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck
      • Magdeburg, Germany, 39108
        • Department of Obestrics and Gynecology, University Magdeburg
      • Tübingen, Germany, 72070
        • Kinderwunschpraxis
      • Wuerzburg, Germany, 97080
        • Department of Obestrics and Gynecology, University Wuerzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

IVF patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OHSS risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months
Time Frame: 12 months after recruitment
12 months after recruitment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Study Chair: Georg Griesinger, PD Dr. med., Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (ESTIMATE)

February 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSS 2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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