Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Georg Griesinger, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00835523
First received: February 2, 2009
Last updated: June 13, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ongoing pregnancy rate/frozen-thawed ET [ Time Frame: 12 months after recruitment ] [ Designated as safety issue: Yes ]
  • Ongoing pregnancy rate/first frozen-thawed ET [ Time Frame: 12 months after recruitment ] [ Designated as safety issue: Yes ]
  • time to pregnancy in weeks [ Time Frame: 12 months after recruitment ] [ Designated as safety issue: No ]
  • incidence of OHSS III° [ Time Frame: 12 months after recruitment ] [ Designated as safety issue: Yes ]
  • number of cumulus-oocyte-complexes [ Time Frame: 12 months after recruitment ] [ Designated as safety issue: Yes ]
  • fertilization rate (number COCs/number of 2 PN oocytes [ Time Frame: 12 months after recruitment ] [ Designated as safety issue: Yes ]
  • survival rate (number of vital embryos/number of frozen 2 PN oocytes [ Time Frame: 12 months after recruitment ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 2, 2009
Last Updated: June 13, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on July 31, 2014