NCT04484181

Brief Summary

The aim of the research is to evaluate the results of the first in vitro fertilization (IVF) attempt according to the type of embryo culture. From the fertilization to the day 2 transfer, embryos are cultured in standard incubator or in a time lapse technology (TLT). TLT offers an uninterrupted culture environment with a morphokinetic evaluation, whereas culture in standard incubator involves discontinuous morphological embryo evaluation. The principal objective is to compare the live birth rate after the fresh embryo transfer, in a cohort of women less than 39 years-old.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Study Progress81%
Oct 2020Sep 2027

First Submitted

Initial submission to the registry

July 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

7 years

First QC Date

July 20, 2020

Last Update Submit

March 28, 2025

Conditions

Infertility

Keywords

EmbryoIn vitro FertilizationSelection, Time lapseSingle embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    Live birth rate per punction after the first single embryo fresh transfer. The live birth will be collected 9 months after the first positive pregnancy test

    Month 9

Secondary Outcomes (4)

  • Cumulative live birth rate

    Month 9

  • Clinical pregnancy rate

    Week 6

  • Ongoing pregnancy rate

    Week 24

  • Delay to obtain a live birth

    Month 9

Study Arms (2)

Embryo culture in time lapse technology (TLT)

EXPERIMENTAL

In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.

Other: Embryo culture in time lapse technology (TLT)

Embryo culture in conventional incubator

ACTIVE COMPARATOR

For the standard incubation group, the selection for transfer was based on morphological criteria. Embryos will be cultured and selected for fresh transfer.

Other: Embryo culture in conventional incubator

Interventions

Embryo culture in time lapse technology (TLT)OTHER

In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.

Embryo culture in time lapse technology (TLT)
Embryo culture in conventional incubatorOTHER

For the standard incubation group, the selection for transfer will be based on morphological criteria. Embryos will be cultured and selected for fresh transfer.

Embryo culture in conventional incubator

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • first IVF/ICSI attempt with fresh transfer,
  • women ≥18 years-old and \<39 years-old,
  • signed informed consent

You may not qualify if:

  • attempts with donor,
  • comprehension problem,
  • frozen gametes,
  • BMI\>35 kg/m2,
  • history of 3 or more miscarriages,
  • uterine pathology,
  • serodiscordant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

clinique Belharra

Bayonne, France

Location

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: In the two arms, embryos were cultured and selected for fresh transfer. For the standard incubation group, the selection for transfer was based on morphological criteria. In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 23, 2020

Study Start

October 1, 2020

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 15, 2027

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)