Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Study of Two Embryo Culture Systems (INCUBATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02722252
Recruitment Status : Unknown
Verified March 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : March 29, 2016
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Infertility Device: Embryoscope Device: Embryo culture system without incorporated camera

Layout table for study information
Study Type : Observational
Estimated Enrollment : 266 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : April 2016
Estimated Primary Completion Date : December 2016

Group/Cohort Intervention/treatment
Embryoscope group Device: Embryoscope
Embryo culture without incorporated camera group Device: Embryo culture system without incorporated camera



Primary Outcome Measures :
  1. Implantation rate [ Time Frame: 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 :
  1. Rate of miscarriages [ Time Frame: 16 weeks after transfer ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Couples who attempt In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722252


Contacts
Layout table for location contacts
Contact: Patricia FAUQUE 03 80 29 51 01 ext +33 patricia.fauque@chu-dijon.fr

Locations
Layout table for location information
France
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Patricia FAUQUE    03 80 29 51 01 ext +33    patricia.fauque@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02722252     History of Changes
Other Study ID Numbers: FAUQUE - INCUBATE
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: March 2016
Keywords provided by Centre Hospitalier Universitaire Dijon:
In Vitro Fertilization with ICSI
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female