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Evaluation of an Artificial Intelligence Model for the Prediction of Human Blastocyst Ploidy Without Invasive Procedures
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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.
Official title: A Non-Invasive Artificial Intelligence Model for the Prediction of Human Blastocyst Ploidy: a Multi-Center, Prospective, Non-Randomized Validation Study
Key Details
Gender
All
Age Range
20 Years - 55 Years
Study Type
OBSERVATIONAL
Enrollment
1408
Start Date
2025-02
Completion Date
2027-12
Last Updated
2025-01-08
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (5)
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Tangdu Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China