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
Verified date | June 2012 |
Source | University of Schleswig-Holstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
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: |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
University of Schleswig-Holstein |
Germany,
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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