Comparative Study of Two Embryo Culture Systems

Completed

• Conditions: Infertility
• Interventions: Device: Embryoscope; Device: Embryo culture system without incorporated camera

• Registration Number: NCT02722252
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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 available

Study Timeline

• Study Start: 2014-08-27
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-03-29
• Primary Completion: 2017-03-29
• Study Completion: 2017-03-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Embryoscope group	Embryoscope	-
Embryo culture without incorporated camera group	Embryo culture system without incorporated camera	-

Primary Outcome Measures

Name	Time	Method
Implantation rate	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.

Secondary Outcome Measures

Name	Time	Method
Rate of miscarriages	16 weeks after transfer

Trial Locations

Locations (1)

CHU de DIJON; 🇫🇷 Dijon, France