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

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Temperature; Extreme, Exposure

Treatments: Device: G210 incubator

Study type: Interventional

Funder types: Other

Identifiers

NCT03548532

2017/060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

36.6°C

Active Comparator group

Description:

Embryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6.

Treatment:

Device: G210 incubator

37.1°C

Experimental group

Description:

Embryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6.

Treatment:

Device: G210 incubator