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

NCT07305480 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Implantation, Embryo

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.

Sponsors & Collaborators

  • Ukraine Association of Biobank

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2023-12-15
Completion
2026-12-15

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07305480 on ClinicalTrials.gov