Comparative Study of Two Embryo Culture Systems

Infertility Clinical Trial

— INCUBATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722252
• Other study ID #: FAUQUE - INCUBATE
• Status: Completed
• Start date: August 27, 2014
• Est. completion date: March 29, 2017

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Embryoscope

• Embryo culture system without incorporated camera

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of miscarriages		16 weeks after transfer