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Comparative Study of Two Embryo Culture Systems (INCUBATE)

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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

Tracking Information
First Submitted Date March 18, 2016
First Posted Date March 29, 2016
Last Update Posted Date June 13, 2016
Study Start Date April 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02722252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 28, 2016)
Rate of miscarriages [ Time Frame: 16 weeks after transfer ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Study of Two Embryo Culture Systems
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
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Couples who attempt In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
Condition Infertility
Intervention
  • Device: Embryoscope
  • Device: Embryo culture system without incorporated camera
Study Groups/Cohorts
  • Embryoscope group
    Intervention: Device: Embryoscope
  • Embryo culture without incorporated camera group
    Intervention: Device: Embryo culture system without incorporated camera
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 28, 2016)
266
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02722252
Other Study ID Numbers FAUQUE - INCUBATE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date March 2016