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Key metrics and processes for validating embryo diagnostics.

Chaim Jalas1, Emre Seli2, Richard T Scott2

  • 1Foundation for Embryonic Competence, Basking Ridge, New Jersey.

Fertility and Sterility
|June 8, 2020
PubMed
Summary
This summary is machine-generated.

Embryo diagnostics in assisted reproduction technology (ART) can improve outcomes but carry risks. Rigorous validation is essential to ensure these diagnostic tools enhance, rather than hinder, the delivery of healthy infants.

Keywords:
Embryo diagnosticsIVFmetricsnonselection study

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Area of Science:

  • Reproductive medicine and developmental biology.
  • Clinical embryology and assisted reproduction technology (ART).

Background:

  • Embryo diagnostics are under investigation in clinical ART.
  • Potential benefits include reducing failed transfers and abnormal pregnancies.
  • Risks involve misidentification and discarding viable embryos, lowering success rates.

Purpose of the Study:

  • To discuss the potential and risks of embryo diagnostics in ART.
  • To emphasize the need for rigorous validation of these technologies.
  • To outline key metrics for validating embryo diagnostic tools.

Main Methods:

  • Review of the current state and challenges of embryo diagnostics.
  • Discussion of validation metrics: analytical validation, predictive values, and clinical trials.
  • Focus on ensuring diagnostics improve, not harm, clinical outcomes.

Main Results:

  • Embryo diagnostics offer potential benefits like single-embryo transfer and reduced pregnancy loss.
  • A significant risk is the misclassification of viable embryos, impacting live birth rates.
  • Validation must include analytical accuracy, predictive value, and demonstrated clinical benefit.

Conclusions:

  • Rigorous validation is crucial for the safe and effective implementation of embryo diagnostics in ART.
  • Validation should encompass analytical, predictive, and clinical outcome measures.
  • Ensuring diagnostics improve live birth rates is the ultimate goal for clinical application.