When and how should new technology be introduced into the IVF laboratory?

Area of Science:

• Reproductive Medicine
• Biotechnology
• Clinical Research

Background:

• Assisted reproduction technology (ART) frequently adopts new methods without sufficient evidence of safety or benefit.
• Established practices like preimplantation genetic screening and vitrification have entered clinical use rapidly.
• Changes in laboratory protocols and culture media are often implemented globally without adequate validation.

Purpose of the Study:

• To emphasize the critical need for comprehensive research and development before introducing novel ART techniques into clinical practice.
• To highlight the potential risks associated with unvalidated technologies in assisted reproduction.
• To advocate for a structured approach to technology adoption in IVF.

Main Methods:

• Review of current practices in assisted reproduction technology.
• Discussion of the importance of evidence-based medicine in ART.
• Proposal for a multi-stage validation process for new technologies.

Main Results:

• Numerous ART procedures have been implemented without adequate safety and efficacy data.
• Potential for unproven technologies to offer no clinical benefit or cause adverse outcomes in children.
• Emerging technologies, like stem cell-derived gametes, necessitate stringent pre-clinical evaluation.

Conclusions:

• A robust validation pathway, including animal studies, research on donated human embryos, and randomized controlled trials, is essential for new ART.
• Clinics must prioritize the safety and efficacy assessment of all new technologies before routine implementation.
• Failure to validate can lead to the introduction of ineffective or harmful ART procedures.