Comparative Study of Two Embryo Culture Systems (INCUBATE)

February 4, 2026 updated by: Centre Hospitalier Universitaire Dijon

Comparative Study of Two Embryo Culture Systems: Randomization of Attempts at In Vitro Fertilization With ICSI at the Centre for Medically Assisted Procreation at Dijon CHU

The centre for Medically-Assisted Procreation (MAP) of Dijon CHU has two high-technology embryo culture systems, with incubation characteristics that are potentially superior to those provided by classical culture systems. Indeed, these two systems, available in only two MAP centres in France, make it possible to maintain a stable temperature and gaseous environment during the in-vitro development of the embryos.

It is necessary to observe the development of the embryos to determine which embryos have the highest implantation potential. These observations are done from time to time by microscope for one system and continuously using an incorporated video camera for the other (cinematographic study). The MAP centre in Dijon wishes to compare the interest of these two systems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de DIJON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Couples who attempt In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)

Description

Inclusion Criteria:

  • Persons who have provided oral consent
  • Attempt at In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
  • At least 6 mature ovocytes to microinject

Exclusion Criteria:

  • Persons not covered by national health insurance
  • Attempt at In Vitro Fertilization (IVF)
  • Fewer than 6 mature ovocytes
  • Decision to transfer at the zygote stage during the multidisciplinary meeting
  • Attempts made in a context of viral risk (both systems are in a virus risk-free zone)
  • Attempts with surgically-harvested spermatozoa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Embryoscope group
Device: Embryoscope
Embryo culture without incorporated camera group
Device: Embryo culture system without incorporated camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 16 weeks after transfer
The implantation rate is defined as the number of embryos implanted (gestational sacs seen on the US scan) compared to the total number of embryos transferred.
16 weeks after transfer

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of miscarriages
Time Frame: 16 weeks after transfer
16 weeks after transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2014

Primary Completion (Actual)

March 29, 2017

Study Completion (Actual)

March 29, 2017

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimated)

March 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAUQUE - INCUBATE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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