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

Temperature; Extreme, Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548532
• Other study ID #: 2017/060
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: January 18, 2023

Study information

• Verified date: January 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: January 18, 2023
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Temperature; Extreme, Exposure

Intervention

Device:
• G210 incubator
very stable culture temperature, up to 0.1°C, in both arms

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	ultrasound: sac and fetal heartbeat positive	7 weeks
Secondary	Fertilization rate	number of fertilized oocytes, per number of injected oocytes	1 day
Secondary	embryo development/utilization rate	number of embryos transferred or cryopreserved per fertilized oocytes	6 days
Secondary	live birth rate of the fresh cycle	number of live births per started cycle	43 weeks
Secondary	cumulative live birth rate per cycle	fresh and frozen embryo transfer: outcome of the deliveries	104 weeks