Mechanics of Human Pre Implantation Development

NCT06408389 | Not Yet Recruiting

• 1 other identifier: APHP210563
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The time-lapse is a closed tri-gas incubator of the latest generation that provides optimal and stable culture conditions for the culture of embryos in In Vitro Fertilization (IVF). The integration of a camera within this incubator allows for continuous image capture, thus facilitating the monitoring of the entire embryonic development, from the day of fertilization to the moment of transfer into the uterus. The contribution of the time-lapse system allows an evaluation of the embryos not only by their morphology, but also by their cell division kinetics, both being direct markers of cell mechanics. Together, these morpho-kinetic data finally allow for the best identification of embryos with greater implantation potential. Time-lapse imaging represents a further step towards an objective assessment of the embryo, but inter- and intra-embryologist variations in annotations partly compromise this objectivity. In addition, many decision algorithms based on the evaluation of morpho-kinetic parameters have been developed, but the lack of reproducibility from one Assisted Reproductive Technology (ART) center to another is a hindrance to the generalization of any particular algorithm. The aim of this retrospective study is to determine morpho-kinetic factors predictive of implantation using machine learning and to link these factors to human embryo mechanistic properties.

Conditions

Infertility

Keywords

In vitro fertilization; embryo; human time lapse; pregnancy; delivery; machine learning

Outcome Measures

Primary Outcomes (1)

• Prediction of embryo implantation by the machine learning algorithm from embryo morphokinetic parameters and patient health data.

  The algorithm outcome will be evaluated retrospectively on human embryos which have been transferred, for which we know whether its implantation was successful and led to birth. Using embryo morphokinetic and health patient data, we will predict a probability of implantion and compare its value (\<0.5: no implantation or \>0.5: implantation) to the true result of the embryo transfer (no implantation or implantation). This will allow us to evaluate the potential of the algorithm to support clinical decision-making in the future.

  2 years

Secondary Outcomes (27)

• Link between couples' parameters and embryo morpho-kinetics

  3 years

• Link between couples' parameters and embryo morpho-kinetics

  3 years

• Link between couples' parameters and embryo morpho-kinetics

  3 years

• Link between couples' parameters and embryo morpho-kinetics

  3 years

• Link between couples' parameters and embryo morpho-kinetics

  3 years

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Couples enrolled in an IVF process (conventional IVF or with sperm micro-injection (ICSI))

You may qualify if:

• Couples enrolled in an IVF process and with embryos cultured in time-lapse
• Couples informed non opposed to research

You may not qualify if:

• Couples opposed to research
• Couples under curator or tutorship
• Couples under state xxx

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Collège de France: collaborator
• Institut Curie: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Catherine PATRAT, MD, PhD

  AP-HP (Professor in Medicine faculty and Hospital practitioner (APHP.centre - Université de Paris, site Cochin)

  PRINCIPAL INVESTIGATOR

• Jean-Léon MAITRE, PhD

  Institut Curie CNRS UMR3215 INSERM U934

  STUDY DIRECTOR

• Hervé TURLIER

  Collège de France, CIRB CNRS UMR7241

  STUDY DIRECTOR

Central Study Contacts

Catherine PATRAT, MD,PhD

CONTACT

00 33 1 58 41 37 34; catherine.patrat@aphp.fr

Marie BNEHAMMANI-GODARD

CONTACT

00 33 1 58 41 11 90; marie.godard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: May 10, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share