Comparative Study of Two Embryo Culture Systems | NCT02722252

Studies
Comparative Study of Two Embryo Culture Systems

NCT02722252

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 6, 2026Actual

Enrollment

388Actual

Phase

Not provided

Conditions

Infertility

Interventions

Embryoscope
Embryo culture system without incorporated camera

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 27, 2014Actual

Primary Completion Date

Mar 29, 2017Actual

Completion Date

Mar 29, 2017Actual

First Submitted Date

Mar 18, 2016

First Submission Date that Met QC Criteria

Mar 28, 2016

First Posted Date

Mar 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 6, 2026Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

388Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Embryoscope group			Device: Embryoscope
Embryo culture without incorporated camera group			Device: Embryo culture system without incorporated camera

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Embryoscope	Device		Embryoscope group
Embryo culture system without incorporated camera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Rate of miscarriages		16 weeks after transfer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de DIJON		Dijon		21079	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29175066	Result	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D019723	Endoscopes
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D013523	Surgical Equipment