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Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00835523
First Posted: February 3, 2009
Last Update Posted: June 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Georg Griesinger, University of Schleswig-Holstein
  Purpose
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.

Condition
Ovarian Hyperstimulation Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Georg Griesinger, University of Schleswig-Holstein:

Primary Outcome Measures:
  • Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months [ Time Frame: 12 months after recruitment ]

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

Enrollment: 51
Study Start Date: May 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
IVF patients
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835523


Locations
Germany
IVF-Augsburg
Augsburg, Germany, 86150
Deutsche Klinik Bad Münder
Bad Münder, Germany, 31848
Department of Obestrics and Gynecology, University Bonn
Bonn, Germany, 53127
Department of Obestrics and Gynecology, University Cologne
Cologne, Germany, 50931
Interdisziplinäres Kinderwunschzentrum
Duesseldorf, Germany, 40219
University Centre for Reproductive Medicine Franken
Erlangen, Germany, 91054
Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck
Luebeck, Germany, 23538
Department of Obestrics and Gynecology, University Magdeburg
Magdeburg, Germany, 39108
Kinderwunschpraxis
Tübingen, Germany, 72070
Department of Obestrics and Gynecology, University Wuerzburg
Wuerzburg, Germany, 97080
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Chair: Georg Griesinger, PD Dr. med. Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck
  More Information

Responsible Party: Georg Griesinger, Director of Department of Reproductive Medicine, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00835523     History of Changes
Other Study ID Numbers: OHSS 2009
First Submitted: February 2, 2009
First Posted: February 3, 2009
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Georg Griesinger, University of Schleswig-Holstein:
frozen-thawed embryo replacement
GnRH agonist
GnRH antagonist
ovarian hyperstimulation

Additional relevant MeSH terms:
Syndrome
Ovarian Hyperstimulation Syndrome
Disease
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases