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

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

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.

Study Overview

• Status: Completed
• Conditions: Temperature; Extreme, Exposure
• Intervention / Treatment: Device: G210 incubator

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 Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Study Director: Greta Verheyen, PhD, UZBrussel

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 26, 2022
• Study Completion (Actual): January 18, 2023

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: temperature
• Other Study ID Numbers: 2017/060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: For statistical Analysis
• IPD Sharing Time Frame: within 6 months after study completion
• IPD Sharing Access Criteria: Only relevant information will be given to the statistician (who is also a clinical doctor in our centre)
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No