Not yet recruiting NCT06408389

Mechanics of Human Pre Implantation Development

— Observational Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Infertility. Basic parameters: 18 years — 43 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

From Oocyte to Embryo: Analysis of Mechanics of Human Pre Implantation Development

Overview

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.

Detailed description

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.

Machine learning is one of the main methods of data analysis that could define algorithms that are unbiased, more robust and applicable to all centers. But the optimal algorithm is not yet defined. Recently, an artificial intelligence approach applied to a large collection of time-lapse embryo images was developed to determine the embryo with the highest grade of evolution, with an AUC\> 0.98. Using clinical data, the authors created a decision tree to integrate embryo quality and female age and identify the chances of pregnancy. However, this approach did not take into account the whole kinetics of development, focusing on certain particular stages, nor the influence of parental and extrinsic factors other than age.

The aim of this retrospective study is to determine morpho-kinetic factors predictive of implantation and embryo development in IVF/ICSI using machine learning algorithms and relate these morpho-kinetic factors to the mechanical characteristics of cells.

Primary outcome measures

Prediction of embryo implantation by the machine learning algorithm from embryo morphokinetic parameters and patient health data. [Time frame: 2 years]

Secondary outcome measures (12)

Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]
Link between couples' parameters and embryo morpho-kinetics [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model: Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06408389 · APHP210563

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗