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ACTIVE NOT RECRUITING
NCT07305480

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

Sponsor: Ukraine Association of Biobank

View on ClinicalTrials.gov

Summary

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.

Official title: Longitudinal Observational Study for Developing and Validating a Digital Twin Model of Human Blastocyst Development, Implantation Potential, and Pregnancy Outcomes Using Fully De-Identified, Multimodal IVF Clinical and Molecular Data

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1

Start Date

2023-01-02

Completion Date

2026-12-15

Last Updated

2025-12-29

Healthy Volunteers

No

Interventions

OTHER

Digital Twin Computational Modeling

Computational digital twin model that analyzes fully de-identified, non-image clinical, molecular, biochemical, and laboratory data from routine IVF care to evaluate embryo implantation potential. The model does not influence clinical decision-making and is used only for retrospective and prospective observational analysis.

Locations (1)

Ukrainian Association of Biobanks Austria - Digital Twin Lab

Graz, Austria