Clinical trial NCT00835523: Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: frozen-thawed embryo replacement
GnRH agonist
GnRH antagonist
ovarian hyperstimulation
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IVF patients

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.


Eligibility 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

Primary outcomes:
measure: Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months
timeFrame: 12 months after recruitment
Secondary outcomes:
measure: ongoing pregnancy rate/frozen-thawed ET
timeFrame: 12 months after recruitment
measure: Ongoing pregnancy rate/first frozen-thawed ET
timeFrame: 12 months after recruitment
measure: time to pregnancy in weeks
timeFrame: 12 months after recruitment
measure: incidence of OHSS III°
timeFrame: 12 months after recruitment
measure: number of cumulus-oocyte-complexes
timeFrame: 12 months after recruitment
measure: fertilization rate (number COCs/number of 2 PN oocytes
timeFrame: 12 months after recruitment
measure: survival rate (number of vital embryos/number of frozen 2 PN oocytes
timeFrame: 12 months after recruitment
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: IVF-Augsburg
city: Bad Münder
country: Germany
facility: Deutsche Klinik Bad Münder
city: Bonn
country: Germany
facility: Department of Obestrics and Gynecology, University Bonn
city: Cologne
country: Germany
facility: Department of Obestrics and Gynecology, University Cologne
city: Duesseldorf
country: Germany
facility: Interdisziplinäres Kinderwunschzentrum
city: Erlangen
country: Germany
facility: University Centre for Reproductive Medicine Franken
city: Luebeck
country: Germany
facility: Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck
city: Magdeburg
country: Germany
facility: Department of Obestrics and Gynecology, University Magdeburg
city: Tübingen
country: Germany
facility: Kinderwunschpraxis
city: Wuerzburg
country: Germany
facility: Department of Obestrics and Gynecology, University Wuerzburg
Study officials:
affiliation: Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck
name: Georg Griesinger, PD Dr. med.
role: STUDY_CHAIR
References: