On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies.
A previous study in our centre analysed stable embryo culture at 36.6°C and 37.1°C, on sibling oocytes. The primary aim was to analyse possible differneces in embryo development (utilization rate) up to day 5/6. In this study, the investigators found a high difference in clinical pregnancy rate between both groups (46.4% versus 77.4%). Since this study was not powered to find differences in clincial pregnancy rates between both groups, this RCT was especially powered as a superiority trial to find differences in clincial pregnancy rates between both groups. On the day of oocyte retrieval, patients will be allocated to culture at one of both temperatures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
234
very stable culture temperature, up to 0.1°C, in both arms
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium
Clinical pregnancy
ultrasound: sac and fetal heartbeat positive
Time frame: 7 weeks
Fertilization rate
number of fertilized oocytes, per number of injected oocytes
Time frame: 1 day
embryo development/utilization rate
number of embryos transferred or cryopreserved per fertilized oocytes
Time frame: 6 days
live birth rate of the fresh cycle
number of live births per started cycle
Time frame: 43 weeks
cumulative live birth rate per cycle
fresh and frozen embryo transfer: outcome of the deliveries
Time frame: 104 weeks
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