Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00835523

Enrollment

Registered

2009-02-03

Start date

2008-05-31

Completion date

2010-07-31

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months	12 months after recruitment

Secondary

Measure	Time frame
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
ongoing pregnancy rate/frozen-thawed ET	12 months after recruitment
fertilization rate (number COCs/number of 2 PN oocytes	12 months after recruitment
survival rate (number of vital embryos/number of frozen 2 PN oocytes	12 months after recruitment
number of cumulus-oocyte-complexes	12 months after recruitment

Countries

Germany

Outcome results