Predicting pregnancy outcomes after assisted reproduction using a machine-learning model

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will develop and validate a machine-learning model that uses early pregnancy data, especially serum beta-hCG values, to predict live birth and differentiate pregnancies at risk for biochemical pregnancy or early loss after ART. Data will come from retrospective clinical records, with a prospective validation cohort receiving no changes to their treatment. The primary focus is on IVF and FET cycles, with exploratory analysis for IUI outcomes. The study aims to provide early, actionable information to improve counseling and management during the first weeks after a positive pregnancy test.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women who underwent ART procedures (IUI, IVF/ICSI, or FET) using homologous oocytes.
* Availability of at least one positive early serum beta-HCG measurement after aspiration, FET, or insemination (beta-HCG \>10 mIU/mL).
* Availability of the pregnancy outcome.
* Availability of relevant patient characteristics and clinical variables required for predictive modeling.
* For embryo-transfer cycles, availability of information on embryo developmental stage and number of embryos transferred where applicable.
* For the prospective validation cohort, written informed consent.

Exclusion Criteria

* Missing beta-HCG measurements critical for model input.
* Missing key demographic or clinical variables required for predictive modeling.
* Missing ART treatment protocol where required for the model.
* Missing pregnancy outcomes.
* Multiple pregnancy, hydatidiform mole, heterotopic pregnancy, and ectopic pregnancy will be excluded from the primary live-birth analysis but will be described separately and, where sample size permits, evaluated as secondary adverse pregnancy outcomes.
* Non-consent for prospective participation in validation.

Where it's running

• Clinical Hospital Center
  Rijeka, Croatia Recruiting
• BetaPlus Center for Reproductive Medicine
  Zagreb, Croatia Recruiting

Study contacts

• Principal investigator: Romana Dmitrovic — BetaPlus Center for Reproductive Medicine
• Study coordinator: Romana Dmitrovic
• Email: romana@betaplus.hr
• Phone: +385981983563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.