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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 36.6°C | Active Comparator | Embryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6. |
|
| 37.1°C | Experimental | Embryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G210 incubator | Device | very stable culture temperature, up to 0.1°C, in both arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy | ultrasound: sac and fetal heartbeat positive | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | number of fertilized oocytes, per number of injected oocytes | 1 day |
| embryo development/utilization rate | number of embryos transferred or cryopreserved per fertilized oocytes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greta Verheyen, PhD | UZBrussel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Brussels | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39241807 | Derived | Wouters K, Mateizel I, Segers I, Van de Velde H, Van Landuyt L, De Vos A, Schoemans C, Jankovic D, Blockeel C, Drakopoulos P, Tournaye H, De Munck N. Clinical pregnancy rates after blastocyst culture at a stable temperature of 36.6 degrees C versus 37.1 degrees C: a prospective randomized controlled trial. Hum Reprod. 2024 Oct 1;39(10):2233-2239. doi: 10.1093/humrep/deae193. |
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For statistical Analysis
within 6 months after study completion
Only relevant information will be given to the statistician (who is also a clinical doctor in our centre)
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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.
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| 6 days |
| live birth rate of the fresh cycle | number of live births per started cycle | 43 weeks |
| cumulative live birth rate per cycle | fresh and frozen embryo transfer: outcome of the deliveries | 104 weeks |