NCT03548532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

September 19, 2024

Status Verified

January 1, 2023

Enrollment Period

5.1 years

First QC Date

October 23, 2017

Last Update Submit

September 4, 2024

Conditions

Temperature; Extreme, Exposure

Keywords

temperature

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    ultrasound: sac and fetal heartbeat positive

    7 weeks

Secondary Outcomes (4)

  • Fertilization rate

    1 day

  • embryo development/utilization rate

    6 days

  • live birth rate of the fresh cycle

    43 weeks

  • cumulative live birth rate per cycle

    104 weeks

Study Arms (2)

36.6°C

ACTIVE COMPARATOR

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

Device: G210 incubator

37.1°C

EXPERIMENTAL

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

Device: G210 incubator

Interventions

G210 incubatorDEVICE

very stable culture temperature, up to 0.1°C, in both arms

Also known as: Ksystems
36.6°C37.1°C

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

  • Wouters K, Mateizel I, Segers I, Van de Velde H, Van Landuyt L, De Vos A, Schoemans C, Jankovic D, Blockeel C, Drakopoulos P, Tournaye H, De Munck N. Clinical pregnancy rates after blastocyst culture at a stable temperature of 36.6 degrees C versus 37.1 degrees C: a prospective randomized controlled trial. Hum Reprod. 2024 Oct 1;39(10):2233-2239. doi: 10.1093/humrep/deae193.

    PMID: 39241807DERIVED

Study Officials

  • Greta Verheyen, PhD

    UZBrussel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 23, 2017

First Posted

June 7, 2018

Study Start

November 1, 2017

Primary Completion

November 26, 2022

Study Completion

January 18, 2023

Last Updated

September 19, 2024

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

For statistical Analysis

Shared Documents
SAP
Time Frame
within 6 months after study completion
Access Criteria
Only relevant information will be given to the statistician (who is also a clinical doctor in our centre)
More information

Locations

BE(1)