Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

Ovarian Hyperstimulation Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835523
• Other study ID #: OHSS 2009
• 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