drugset / Trial / NCT00756028

Short Versus Long Protocol for IVF and IVF+ICSI

NCT00756028

Phase 4 Completed 1099 enrolled Peter Hornnes, MD, DMSc
RandomizedParallel-groupOpen-labelTreatment

Summary

Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to 1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure) 2. quality of life (2. outcome measure) 3. live birth rate (2. outcome measure) 4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and 5. number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures). In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.

Timeline

Start
2009-01
Primary completion
2014-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganirelix Protein / enzyme biologic 0.25 mg Subcutaneous
Comparator Nafarelin Other / unclassified