Temperature; Extreme, Exposure
Conditions
Keywords
temperature
Brief summary
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.
Detailed description
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.
Interventions
DEVICEG210 incubator
very stable culture temperature, up to 0.1°C, in both arms
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Based on the randomisation list, patients fulfilling the inclusion criteria will be assigned to one of each arm. A total of 119 patients are needed in every arm in this superiority trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Day 5 transfer * Single embryo transfer * Only ejaculated sperm (fresh or frozen, autologous or heterologous) * BMI \<35 * Age \<40 years * Cycle rank \<3 for the current child * Last ultrasound: 8 follicles of at least 12 mm * At least 6 mature oocytes
Exclusion criteria
* IVF * IVF versus ICSI * Failed fertilization in previous cycle * no previous cycle without embryo transfer * No use of Ca ionophores for embryo quality or fertilization problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 7 weeks | ultrasound: sac and fetal heartbeat positive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate of the fresh cycle | 43 weeks | number of live births per started cycle |
| Fertilization rate | 1 day | number of fertilized oocytes, per number of injected oocytes |
| embryo development/utilization rate | 6 days | number of embryos transferred or cryopreserved per fertilized oocytes |
| cumulative live birth rate per cycle | 104 weeks | fresh and frozen embryo transfer: outcome of the deliveries |
Countries
Belgium
Outcome results
None listed