Embryo Culture at a Constant Temperature of 36.6°C or 37.1°C

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Embryo Culture at a Constant Temperature of 36.6°C or 37.1°C: A Randomized Controlled Trial

Conditions
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Temperature; Extreme, Exposure

Intervention / Treatment
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* Device: G210 incubator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 36.6°C<br>Embryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6. | Device: G210 incubator<br>* very stable culture temperature, up to 0.1°C, in both arms<br>* Other names: Ksystems;|
| Experimental: 37.1°C<br>Embryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6. | Device: G210 incubator<br>* very stable culture temperature, up to 0.1°C, in both arms<br>* Other names: Ksystems;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | ultrasound: sac and fetal heartbeat positive | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temperature