Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

NCT00835523 | Completed DMC

• 1 other identifier: OHSS 2009
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 10

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.

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

frozen-thawed embryo replacement; GnRH agonist; GnRH antagonist; ovarian hyperstimulation

Outcome Measures

Primary Outcomes (1)

• Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months

  12 months after recruitment

Secondary Outcomes (7)

• 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

Study Arms (1)

OHSS risk

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

IVF patients

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (10)

IVF-Augsburg

Augsburg, 86150, Germany

Location

Deutsche Klinik Bad Münder

Bad Münder am Deister, 31848, Germany

Location

Department of Obestrics and Gynecology, University Bonn

Bonn, 53127, Germany

Location

Department of Obestrics and Gynecology, University Cologne

Cologne, 50931, Germany

Location

Interdisziplinäres Kinderwunschzentrum

Düsseldorf, 40219, Germany

Location

University Centre for Reproductive Medicine Franken

Erlangen, 91054, Germany

Location

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

Lübeck, 23538, Germany

Location

Department of Obestrics and Gynecology, University Magdeburg

Magdeburg, 39108, Germany

Location

Kinderwunschpraxis

Tübingen, 72070, Germany

Location

Department of Obestrics and Gynecology, University Wuerzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Georg Griesinger, PD Dr. med.

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Reproductive Medicine

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

DE (10)