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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00835523
Other study ID # OHSS 2009
Secondary ID
Status Completed
Phase N/A
First received February 2, 2009
Last updated June 13, 2012
Start date May 2008
Est. completion date July 2010

Study information

Verified date June 2012
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 39 Years
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Ovarian Hyperstimulation Syndrome

Locations

Country Name City State
Germany IVF-Augsburg Augsburg
Germany Deutsche Klinik Bad Münder Bad Münder
Germany Department of Obestrics and Gynecology, University Bonn Bonn
Germany Department of Obestrics and Gynecology, University Cologne Cologne
Germany Interdisziplinäres Kinderwunschzentrum Duesseldorf
Germany University Centre for Reproductive Medicine Franken Erlangen
Germany Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck Luebeck
Germany Department of Obestrics and Gynecology, University Magdeburg Magdeburg
Germany Kinderwunschpraxis Tübingen
Germany Department of Obestrics and Gynecology, University Wuerzburg Wuerzburg

Sponsors (1)

Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months 12 months after recruitment Yes
Secondary ongoing pregnancy rate/frozen-thawed ET 12 months after recruitment Yes
Secondary Ongoing pregnancy rate/first frozen-thawed ET 12 months after recruitment Yes
Secondary time to pregnancy in weeks 12 months after recruitment No
Secondary incidence of OHSS III° 12 months after recruitment Yes
Secondary number of cumulus-oocyte-complexes 12 months after recruitment Yes
Secondary fertilization rate (number COCs/number of 2 PN oocytes 12 months after recruitment Yes
Secondary survival rate (number of vital embryos/number of frozen 2 PN oocytes 12 months after recruitment Yes
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