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

January 6, 2025 updated by: Wang Shanshan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

A Non-Invasive Artificial Intelligence Model for the Prediction of Human Blastocyst Ploidy: a Multi-Center, Prospective, Non-Randomized Validation Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

A pilot study has been conducted at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School from August 2023 to September 2024. Videos and preimplantation genetic testing (PGT) results from 144 blastocysts were retrospectively collected. The artificial intelligence (AI) model first reconstructed the 3D surface of the blastocysts from the videos, and then measured their 3D morphological parameters. Based on these parameters, the model predicted the ploidy status of the blastocysts, and the prediction outputs were compared with the PGT results. The prediction sensitivity, specificity, accuracy and AUC were 90.5%, 91.3%, 90.9% and 0.946, respectively.

Study design:

This is a multi-center, prospective, non-randomized, non-blinded, and single-group study. After being informed about the study and potential risks, all participants will write the informed consents. Videos and PGT results of Day 5/6 blastocysts from each participant will be collected. Blastocysts will be classified as euploid, mosaic, and aneuploid corresponding to <30%, 30-80%, and >80% aneuploidy, respectively. Embryo culture, biopsy, and transfer will follow the standard operating procedure (SOP) in the laboratory. The study is non-interventional, and results will not be used to make treatment decisions.

Sample size:

We plan to enroll ~1408 Day 5/6 blastocysts in this trial based on one-sample sensitivity and specificity analysis. Meta-analysis shows that the sensitivity and specificity of the existing AI models are 73.4% (3702/5047) and 69.6% (4892/7028), and those of the non-invasive chromosomal screening methods are 80.3% (678/844) and 73.3% (908/1238) for non-invasively predicting blastocyst ploidy status. This study is presumed to achieve a sensitivity of no less than 85% and a specificity of no less than 80% with a significance level of α = 0.05. A total of 1126 blastocysts are required to achieve a statistical power of 0.9. Assuming a ~20% dropout rate, a total of 1408 blastocysts are anticipated to be enrolled. This sample size calculation is based on the analysis of statistical power and will be regularly revisited/adjusted during the trial period to ensure a high statistical power is achieved.

Data management:

The electronic data capture (EDC) system will be used for data collection. A clinical research coordinator will be assigned at each hospital, and they are responsible for recording the videos and clinical data via the EDC system. A senior clinical research associate will inspect the data in the EDC system regularly among 5 hospitals. The Data Safety and Monitoring Committee (DSMC) is responsible for overseeing the entire research process and the EDC system. For incomplete or missing data in the EDC system, the DSMC will contact the investigators for clarification.

Statistical analysis:

Statistical analysis will be conducted using IBM SPSS Statistics 26. Categorical variables will be described by number and percentage, and numerical variables will be described by mean, standard deviation (SD) and range. The Chi-squared test will be performed to analyze trends in categorical variables, and the t-test will be performed to compare numerical variables among different groups. Pearson correlation will be used to analyze the linear relationship among numerical variables. All statistical tests are two-tailed. P-values of <0.05 will be considered statistically significant, and odd ratios (ORs) with 95% confidence interval (CI) will be calculated. Logistic regression will be used for multivariate analysis to calculate the adjusted odd ratios (aORs). The performance of the AI for blastocyst ploidy prediction will be evaluated by sensitivity, specificity, accuracy and AUC, with 95% confidence interval.

Missing data will be removed if the proportion of samples with missing values is very small relative to the total sample size. Otherwise, the average, maximum, minimum, medium, or regression model will be used to impute the missing values. Outliers will be treated as the missing data and addressed accordingly.

Study Type

Observational

Enrollment (Estimated)

1408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • Contact:
        • Contact:
          • Limin Wu
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
        • Contact:
        • Contact:
          • Haixiang Sun
    • Jiangxi
      • Nanchang, Jiangxi, China, 330046
        • Jiangxi Maternal and Child Health Hospital
        • Contact:
        • Contact:
          • Yan Zhao
    • Shaanxi
      • Xi'an, Shaanxi, China, 710024
        • Tangdu Hospital of Air Force Military Medical University
        • Contact:
          • Xiaohong Wang
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Yun Sun
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: Through study completion, an average of 1 year
Accuracy evaluates the number of correct predictions of blastocyst ploidy over the total number of predictions
Through study completion, an average of 1 year
AUC
Time Frame: Through study completion, an average of 1 year
AUC is defined as the area under the receiver operating characteristic curve, which evaluates the overall model performance for predicting blastocyst ploidy regardless of classification threshold.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborators

Jiangxi Maternal and Child Health Hospital
Tangdu Hospital of Air Force Military Medical University
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Haixiang Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-739-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD will be shared according to the data access criteria.

IPD Sharing Time Frame

Beginning 3 months after publication or one year after completion of the trial with no end date

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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