InfertilityINCUBATENCT02722252
Comparative Study of Two Embryo Culture Systems
An observational study of Infertility, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Embryoscope and Embryo culture system without incorporated camera
- Type of treatment
- Medical device
- How many people
- 388 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2014to 29 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Couples who attempt In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
Who may be able to join
- Persons who have provided oral consent
- Attempt at In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
- At least 6 mature ovocytes to microinject
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Infertility
- Being tested
- Embryoscope, Embryo culture system without incorporated camera
- Keywords
- In Vitro Fertilization with ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryoscopeDevice
Embryo culture system without incorporated cameraDevice
| Study group | Role | What they receive |
|---|---|---|
| Embryoscope group | Not described Receives: Device: Embryoscope | |
| Embryo culture without incorporated camera group | Not described Receives: Device: Embryo culture system without incorporated camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks after transfer
Secondary outcomes (1)
Rate of miscarriages
Measured: 16 weeks after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start27 Aug 2014
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722252
- Sponsor's protocol ID
- FAUQUE - INCUBATE
- Acronym
- INCUBATE
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
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.
PubMed 29175066
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02722252
- Acronym / sponsor ID
- INCUBATE / FAUQUE - INCUBATE
- Conditions
- Infertility
- Keywords
- In Vitro Fertilization with ICSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 27 Aug 2014 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embryoscope group | – | Device: Embryoscope |
| Embryo culture without incorporated camera group | – | Device: Embryo culture system without incorporated camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Couples who attempt In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
Key inclusion criteria (3 listed)
- Persons who have provided oral consent
- Attempt at In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
- At least 6 mature ovocytes to microinject
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embryoscope | Device | Embryoscope group |
| Embryo culture system without incorporated camera | Device | Embryo culture without incorporated camera group |
Primary outcome
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.
1 secondary outcome
Rate of miscarriages
Time frame: 16 weeks after transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 29175066Barberet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: 16 weeks after transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.