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

Not Applicable

Completed

• Conditions: Temperature; Extreme, Exposure
• Interventions: Device: G210 incubator

• Registration Number: NCT03548532
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2017-10-23
• Study Start: 2017-11-01
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-07
• Primary Completion: 2022-11-26
• Status Verified: 2023-01
• Study Completion: 2023-01-18
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
36.6°C	G210 incubator	Embryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6.
37.1°C	G210 incubator	Embryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	7 weeks	ultrasound: sac and fetal heartbeat positive

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	1 day	number of fertilized oocytes, per number of injected oocytes
live birth rate of the fresh cycle	43 weeks	number of live births per started cycle
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

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium