Longitudinal Clinical Observation of a Digital Twin Model for Blastocyst Evaluation in IVF Clinics

This study aims to develop and validate a non-image, multimodal digital twin model of the human blastocyst using fully de-identified clinical, laboratory, molecular, biochemical, and long-term follow-up data obtained during routine IVF treatment. The dataset includes parental clinical background, IVF cycle parameters, embryo morphology in text format, PGT-A results, secretome and exosomal biomarkers, endometrial receptivity profiles, pregnancy course, delivery outcomes, and child development data up to 3 years of age. The purpose of this observational study is to create a longitudinal reference dataset linking embryo-level molecular and biochemical characteristics with clinical outcomes from implantation to early childhood. The digital twin model is intended to investigate predictors of implantation success, embryo viability, and early developmental trajectories without the use of images or videos. No investigational drugs or devices are used, and no procedures beyond standard clinical practice are added.

NCT Number	NCT07305480
Lead Sponsor	Ukraine Association of Biobank
Conditions	Implantation, Embryo
Enrollment	1 participants
Start Date	2023-01-02
Primary Completion	2023-12-15 (estimated)
Study Completion	2026-12-15 (estimated)
Updated on ClinicalTrials.gov	2025-12-29