Comparative Study of Two Embryo Culture Systems

NCT ID: NCT02722252

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

388 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-27

Study Completion Date

2017-03-29

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Embryoscope group

Embryoscope

Intervention Type DEVICE

Embryo culture without incorporated camera group

Embryo culture system without incorporated camera

Intervention Type DEVICE

Interventions

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Embryoscope

Intervention Type DEVICE

Embryo culture system without incorporated camera

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de DIJON

Dijon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29175066 (View on PubMed)

Other Identifiers

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FAUQUE - INCUBATE

Identifier Type: -

Identifier Source: org_study_id

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