Reproductive DisorderEMCIMONCT03806153
Interest of Morphokinetic Parameters of Early Embryonic Development in the Birth Rates in Vitro Fertilization
A study testing Morphokinetic in people with Reproductive Disorder, run by University Hospital, Rouen at 2 sites in France.
Trial summary
In France, nearly 3% of children are conceived by the technique of Assisted Reproductive Medicine, of which nearly 70% by in vitro fertilization (IVF). The rates of clinical pregnancy by oocyte retrieval or embryo transfer have not changed much. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Reproductive Disorder
- What is being tested?
- Morphokinetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Oct 2020to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- For the couple:
- Couple whose two members are 18 years old and over,
- Couple whose two members are affiliated to a social security scheme,
- Couple whose two members read and understood the newsletter and signed the consent form for their participation in this research.
- For the conditions of realization of the ICSI attempt:
- Couple supported for a 1st or 2nd attempt at in vitro fertilization with sperm microinjection (ICSI) for male infertility,
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- In vitro fertilization attempt performed with micro-injection of fresh ejaculated spermatozoa.
- For the man:
- Couple whose man has an alteration of at least one of the sperm parameters according to the WHO (WHO, 2010) for the number, concentration, vitality, mobility or morphology according to the modified David classification (Auger and Eustache, 2000).
Who cannot join
- For the couple:
- Couple whose wife is under 18 and over 42 and / or the male is under 18 and over 59
- Couple already included in the protocol "EMCIMO" for a previous attempt,
- Couple of which one or both members is deprived by an administrative or judicial decision or subject to a legal measure of protection of the majors (safeguard of justice or tutelage or curatorship),
- Couple where one or both members do not speak or understand French.
- For the conditions of realization of the ICSI attempt:
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- In vitro fertilization attempt with the micro-injection of testicular spermatozoa, epididymal, previously frozen or resulting from a retrograde ejaculation.
- For the man:
- Severe oligozoospermia (<100,000 spermatozoa / ejaculate).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Do the Morphokinetic Parameters of Early Embryonic Development Have an Interest in the Choice of the Embryo to be Transferred and Improve Birth Rates in Vitro Fertilization
In France, nearly 3% of children are conceived by the technique of Assisted Reproductive Medicine, of which nearly 70% by in vitro fertilization (IVF). The rates of clinical pregnancy by oocyte retrieval or embryo transfer have not changed much. The use of mono-embryo transfer reduces the risk of multiple pregnancies and associated obstetric complications. The choice of embryo to transfer or freeze is a key element in improving the chances of success of IVF. It is usually based on conventional morphological criteria (reference method) that are punctual, qualitative and subjective. However, embryo morphology at early stages has little predictive value for obtaining a late-stage embryo and its chances of implantation. The recent use of time-lapse technology during embryonic culture makes it possible to associate morphological criteria with continuous monitoring of the kinetics of embryonic development. The choice of the embryo to be transferred is then made according to morphokinetic criteria (conventional morphological criteria to which are added the data of the kinetics of embryonic development).
Two recent retrospective studies give contradictory results, the first shows higher birth rates in the group of embryos selected according to conventional morphological criteria, the second concludes that morphokinetic analysis is superior. Morphokinetic criteria would also be more objective and reproducible. However, the use of morphokinetic parameters remains controversial in the literature.
- Conditions
- Reproductive Disorder
- Being tested
- Morphokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphokineticOther
The embryos will be observed at a fixed time and according to morphological criteria (Alpha Specialist Group in Reproductive Medicine and ESHRE, 2011). and all the films obtained will be analyzed. Embryos will be classified according to morphokinetic criteria (Ciray et al., 2014).
| Study group | Role | What they receive |
|---|---|---|
| Conventional morphology arm (reference method) | Active comparator | Not described Receives: Other: Morphokinetic |
| Morphokinetic arm | Experimental | Not described Receives: Other: Morphokinetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study will be the live birth rate by fresh embryo transfer(s).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start26 Oct 2020
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806153
- Sponsor's protocol ID
- 2017/385/HP
- Acronym
- EMCIMO
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2019
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do the Morphokinetic Parameters of Early Embryonic Development Have an Interest in the Choice of the Embryo to be Transferred and Improve Birth Rates in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT03806153
- Acronym / sponsor ID
- EMCIMO / 2017/385/HP
- Conditions
- Reproductive Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 16 Jan 2019 (actual)
- 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.
In France, nearly 3% of children are conceived by the technique of Assisted Reproductive Medicine, of which nearly 70% by in vitro fertilization (IVF). The rates of clinical pregnancy by oocyte retrieval or embryo transfer have not changed much. The use of mono-embryo transfer reduces the risk of multiple pregnancies and associated obstetric complications. The choice of embryo to transfer or freeze is a key element in improving the chances of success of IVF. It is usually based on conventional morphological criteria (reference method) that are punctual, qualitative and subjective. However, embryo morphology at early stages has little predictive value for obtaining a late-stage embryo and its chances of implantation. The recent use of time-lapse technology during embryonic culture makes it possible to associate morphological criteria with continuous monitoring of the kinetics of embryonic development. The choice of the embryo to be transferred is then made according to morphokinetic criteria (conventional morphological criteria to which are added the data of the kinetics of embryonic development).
Two recent retrospective studies give contradictory results, the first shows higher birth rates in the group of embryos selected according to conventional morphological criteria, the second concludes that morphokinetic analysis is superior. Morphokinetic criteria would also be more objective and reproducible. However, the use of morphokinetic parameters remains controversial in the literature.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional morphology arm (reference method) | Active comparator | Other: Morphokinetic |
| Morphokinetic arm | Experimental | Other: Morphokinetic |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- For the couple:
- For the conditions of realization of the ICSI attempt:
- For the man:
Key exclusion criteria (9 listed)
- For the couple:
- For the conditions of realization of the ICSI attempt:
- For the man:
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 |
|---|---|---|
| MorphokineticThe embryos will be observed at a fixed time and according to morphological criteria (Alpha Specialist Group in Reproductive Medicine and ESHRE, 2011). and all the films obtained will be analyzed. Embryos will be classified according to morphokinetic criteria (Ciray et al., 2014). | Other | Conventional morphology arm (reference method), Morphokinetic arm |
Primary outcome
The primary endpoint of this study will be the live birth rate by fresh embryo transfer(s).
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphokinetic in people with Reproductive Disorder, run by University Hospital, Rouen at 2 sites 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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary endpoint of this study will be the live birth rate by fresh embryo transfer(s). (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026.