NCT02722252

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
388

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

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

Study Start

First participant enrolled

August 27, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

March 18, 2016

Last Update Submit

February 4, 2026

Conditions

Keywords

In Vitro Fertilization with ICSI

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    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 Outcomes (1)

  • Rate of miscarriages

    16 weeks after transfer

Study Arms (2)

Embryoscope group

Device: Embryoscope

Embryo culture without incorporated camera group

Device: Embryo culture system without incorporated camera

Interventions

Embryoscope group
Embryo culture without incorporated camera group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

Related Publications (1)

  • Barberet J, Chammas J, Bruno C, Valot E, Vuillemin C, Jonval L, Choux C, Sagot P, Soudry A, Fauque P. Randomized controlled trial comparing embryo culture in two incubator systems: G185 K-System versus EmbryoScope. Fertil Steril. 2018 Feb;109(2):302-309.e1. doi: 10.1016/j.fertnstert.2017.10.008. Epub 2017 Nov 23.

MeSH Terms

Conditions

Infertility

Interventions

Fetoscopes

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 29, 2016

Study Start

August 27, 2014

Primary Completion

March 29, 2017

Study Completion

March 29, 2017

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations