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

NCT06762704 | Not Yet Recruiting DMC

• 1 other identifier: 2024-739-02
• Study Type: observational
• Target: 1,408
• Locations: 1 country
• Sites: 5

Brief 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)

Keywords

Blastocyst Evaluation; Prediction of Human Blastocyst Ploidy; 3D Morphological Measurement of Human Blastocysts; Non-Invasive Evaluation of Human Blastocysts

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Sensitivity = TP/(TP+FN). TP: number of outcomes where a euploid blastocyst is correctly predicted as euploidy. FN: number of outcomes where a euploid blastocyst is incorrectly predicted as aneuploidy. High sensitivity indicates strong ability for the prediction of euploid blastocysts.

  Through study completion, an average of 1 year

• Specificity

  Specificity = TN/(TN+FP). TN: number of outcomes where an aneuploid blastocyst is correctly predicted as aneuploidy. FP: number of outcomes where an aneuploid blastocyst is incorrectly predicted as euploidy. High specificity indicates strong ability for the prediction of aneuploid blastocysts.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Accuracy

  Through study completion, an average of 1 year

• AUC

  Through study completion, an average of 1 year

Interventions

Video recording OTHER

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.

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study is a multi-center trial which will be conducted in five reproductive medicine centers in eight provinces (Jiangsu, Shanghai, Jiangxi, Shaanxi, and Anhui) across China. The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School will serve as the primary investigate center. Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Jiangxi Maternal and Child Health Hospital, Tangdu Hospital of Air Force Military Medical University, and The First Affiliated Hospital of USTC (Anhui Provincial Hospital) will serve as the participant investigate centers. Videos that include multi-view images of human blastocysts will be collected on Day 5/6 of culture. PGT-A results of these blastocysts will be collected 4-8 weeks after trophectoderm biopsy. The study is non-interventional, and results will not be used to make treatment decisions.

You may qualify if:

• Maternal age between 20 and 40; paternal age between 20 and 55.
• Preimplantation genetic testing (PGT) cycles, including PGT for aneuploidy, PGT for monogenic disorders (PGT-M) or PGT for structural chromosome defect (PGT-SR).
• Having at least one Day 5/6 blastocyst developed from two-pronuclear (2PN) embryo which is suitable for trophectoderm biopsy (i.e., degree of expansion: IV, and at least a grade better than C for trophectoderm and inner cell mass grading).
• Couples with written informed consent.

You may not qualify if:

• Couples with contraindications for IVF or PGT.
• Women with all oocytes frozen after retrieval.
• Couples who fail to follow the study protocol.
• Couples deemed ineligible for enrollment by the investigator in consideration of study protocol and treatment safety.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• RenJi Hospital: collaborator
• Jiangxi Maternal and Child Health Hospital: collaborator
• Tangdu Hospital of Air Force Military Medical University: collaborator
• The First Affiliated Hospital of USTC (Anhui Provincial Hospital): collaborator

Study Sites (5)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, 230001, China

Location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, 330046, China

Location

Tangdu Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710024, China

Location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (23)

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Biospecimen

Retention: SAMPLES WITH DNA

Five to eight trophectoderm cells will be biopsied and collected from each Day 5/6 blastocyst. Preimplantation genetic testing for aneuploidy will then be conducted on these cells, and the test reports will be recorded.

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Haixiang Sun

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanshan Wang

CONTACT

13814549922; wss_19860820@sina.com

Haixiang Sun

CONTACT

13851622008; stevensunz@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Reproductive Medicine

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months after publication or one year after completion of the trial with no end date
• Access Criteria: The study protocol, statistical analysis plan, informed consent form and clinical study report will be available in publications. IPD that underlie results in publications will be shared online with the publications. Analytic codes will be available at the open-source online platform, e.g., Github. All other IPD collected for the study, including specified dataset and a data dictionary defining each field in the set, will be shared on reasonable request to the principal investigator at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School via emails. Principal investigators from all five participant hospitals will review the request in consideration of patient privacy, data safety, and data analyses plan.

Locations

CN (5)