Longitudinal Clinical Observation of a Digital Twin Model for Blastocyst Evaluation in IVF Clinics (NCT07305480) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Longitudinal Clinical Observation of a Digital Twin Model for Blastocyst Evaluation in IVF Clinics
Austria1 participantsStarted 2023-01-02
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women undergoing in vitro fertilization (IVF) treatment at participating fertility clinics.
* Availability of non-image embryo development data.
* Availability of text-based morphological embryo descriptions.
* Availability of PGT-A results.
* Availability of secretome and exosomal biomarker data.
* Availability of molecular and biochemical data collected during routine clinical care.
* Availability of IVF cycle parameters collected during routine clinical workflow.
* Embryos evaluated according to standard clinic protocols with documented implantation outcomes.
* Age of the oocyte provider between 20 and 42 years.
* Signed informed consent allowing use of fully de-identified clinical, laboratory, molecular, and follow-up data.
Exclusion Criteria:
* Embryos lacking sufficient non-image developmental data required for digital twin generation or implantation outcome assessment.
* Use of donor oocytes or donor embryos when linkage with required clinical or laboratory metadata is not possible.
* Cases in which implantation outcome cannot be confirmed.
* Presence of severe uterine abnormalities prior to embryo transfer that may affect implantation reliability.
* Withdrawal of consent for use of anonymized clinical, laboratory, or follow-up data.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of Digital Twin Model in Predicting Embryo Implantation
Timeframe: From embryo transfer (Day 0) to confirmation of clinical pregnancy (up to 12 weeks of gestation).