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Evaluation of an Artificial Intelligence Model for the Prediction of Human Blastocyst Ploidy Without Invasive Procedures

NCT06762704 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1408

Last updated 2025-01-08

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate an artificial intelligence model for the prediction of human blastocyst ploidy without invasive procedures in couples that receive preimplantation genetic testing. The main questions it aims to answer are:

* Is an artificial intelligence model able to predict the ploidy status of a human blastocyst based on its 3D morphology?
* Do quantitative 3D morphological parameters of trophectoderm cells and inner cell mass have strong correlations with human blastocyst ploidy status?

Videos that include multi-view images of each blastocyst from participants will be collected on Day 5/6 of culture, and preimplantation genetic testing results of these blastocysts will be collected 4-8 weeks after trophectoderm biopsy.

Conditions

  • The Focus is to Validate the Accuracy of a Non-invasive Artificial Intelligence Model for the Prediction of the Human Blastocyst Ploidy
  • Preimplantation Genetic Testing (PGT)

Interventions

OTHER

Video recording

Videos of rotating the blastocysts will be recorded during the preparation stage of trophectoderm (TE) biopsy. The focal plane starts from the middle plane of the blastocyst. and then moves downwards until individual TE cells and inner cell mass (ICM) are clearly visible. A biopsy micropipette is used to gently push the blastocyst and rotate the blastocyst each time by a small angle, for instance, smaller than 35° such that more than 10 images can be captured for the entire 360° rotation to achieve high-accuracy measurement. After the first 360° rotation, the second one will be conducted around the axis perpendicular to the previous axis to ensure the whole surface of the blastocyst is captured. The entire rotation process will be video recoded.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Jiangxi Maternal and Child Health Hospital

    collaborator OTHER

  • Tangdu Hospital of Air Force Military Medical University

    collaborator UNKNOWN

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    collaborator UNKNOWN

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Haixiang Sun · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06762704 on ClinicalTrials.gov