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Related Concept Videos

In Vitro Fertilization01:24

In Vitro Fertilization

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In vitro fertilization (IVF) is a form of assisted reproductive technology where an egg is fertilized with sperm in a controlled laboratory environment before transferring the resulting embryo into the uterus. This process is designed to help individuals and couples experiencing difficulties conceiving.
The IVF process begins with ovarian stimulation, during which reproductive endocrinologists prescribe hormonal medications to stimulate the ovaries to produce multiple eggs instead of the single...
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Updated: Jan 14, 2026

Semiconductor Sequencing for Preimplantation Genetic Testing for Aneuploidy
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Reframing analytical validation in preimplantation genetic testing: phase 1.

Mina Popovic1, Emily Mounts2, Chaim Jalas2

  • 1Department of Reproductive Medicine, Ghent University Hospital, Ghent, Belgium.

Fertility and Sterility
|October 17, 2025
PubMed
Summary
This summary is machine-generated.

Analytical validation ensures reliable preimplantation genetic testing (PGT). This review offers a framework for PGT assay validation, focusing on precision, accuracy, and feasibility for better reproductive medicine outcomes.

Keywords:
Analytical validationPGTanalytical accuracypreimplantation genetic testing

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Area of Science:

  • Reproductive Medicine
  • Molecular Diagnostics
  • Clinical Genetics

Background:

  • Analytical validation is crucial for diagnostic tests but inconsistently applied in preimplantation genetic testing (PGT).
  • PGT involves minute DNA quantities, requiring amplification and complex bioinformatics, introducing unique validation challenges.
  • Limited regulatory oversight and proprietary platforms place validation responsibility on laboratories.

Purpose of the Study:

  • To reframe analytical validation principles specifically for PGT.
  • To provide a structured framework for assessing PGT assay analytical performance.
  • To emphasize the importance of robust validation for clinical application in reproductive medicine.

Main Methods:

  • Review of analytical validation principles in the context of PGT.
  • Focus on three core pillars: precision, accuracy, and feasibility.
  • Discussion of amplification strategies, validation models, and quality control metrics for PGT assays.

Main Results:

  • PGT's unique technical challenges necessitate tailored validation approaches.
  • A structured framework is proposed to assess PGT analytical performance.
  • Harmonized terminology, transparent reporting, and platform-level validation are identified as key needs.

Conclusions:

  • Analytical validation is essential for reliable PGT.
  • A harmonized approach to PGT validation is needed to bridge innovation and clinical practice.
  • Implementing robust validation ensures responsible application of genetic testing in reproductive medicine.