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

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Dec 31, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on testing a new artificial intelligence (AI) model that aims to predict the genetic health of embryos, specifically human blastocysts, without needing to perform invasive procedures. By looking at the 3D shape and structure of the blastocysts, the researchers want to see if the AI can accurately determine if they are healthy (called "ploidy status"). Participants in the study will have images of their blastocysts taken on Day 5 or 6 of embryo development, and the results of any genetic testing will be gathered a few weeks later.

To be eligible for the trial, couples need to meet certain criteria. Women should be between 20 and 40 years old, and men between 20 and 55 years old. They must be undergoing specific types of genetic testing for their embryos and have at least one suitable blastocyst for testing. It's important to note that couples who have certain health issues or those who have frozen all their eggs are not eligible. Participants can expect to contribute to important research that could improve how embryos are evaluated in the future, ultimately helping couples trying to conceive.

Gender

ALL

Eligibility criteria

• 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.