Clinical validation of embryo prognostic tests; determining predictive value: phase 2

Area of Science:

• Reproductive Medicine
• Clinical Embryology
• Genetic Testing

Background:

• Clinical tests, including those for embryo competence, must be safe and effective.
• Validating tests for human embryos presents unique challenges compared to other clinical tests.
• Effective validation paradigms are crucial for reliable embryo testing.

Purpose of the Study:

• To detail the methodology for performing clinical validation of embryo tests.
• To address the challenges specific to validating tests on human embryos.
• To provide a framework for designing and implementing effective embryo test validation.

Main Methods:

• Discussion of prognostic versus diagnostic test concepts.
• Consideration of mosaicism and appropriate endpoint measures.
• Guidance on study design, sample size, patient cohorts, blinding, and data analysis.

Main Results:

• Preimplantation genetic tests serve as a practical example due to their widespread use.
• The manuscript covers key aspects of validation methodology.
• Understanding challenges is essential for effective validation.

Conclusions:

• A robust validation methodology is essential for clinical embryo tests.
• This manuscript provides a comprehensive guide to embryo test validation.
• Effective validation ensures the safety and efficacy of embryo testing for reproductive outcomes.