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

TLDR

In assisted reproduction, new technologies such as pre‑implantation genetic screening, assisted hatching, in‑vitro maturation, blastocyst transfer, vitrification, and changes to culture media or stimulation protocols are often adopted clinically without sufficient evidence of safety or benefit. The study emphasizes that IVF clinics must conduct rigorous research and development—especially as stem‑cell‑derived gametes approach clinical use—before introducing new techniques. The recommended pathway involves initial animal model studies, followed by research on donated human embryos, and culminating in well‑designed randomized controlled trials with long‑term follow‑up of all resulting children. Failure to publish such preliminary studies risks the introduction of technologies that provide no clinical advantage or that cause adverse health outcomes in offspring.

Abstract

There are many examples in assisted reproduction technology, where new technology and methods have been introduced into the clinical setting without appropriate development and evidence-based medicine to show that the procedure is safe and beneficial to the patient. Examples include preimplantation genetic screening, assisted hatching, in vitro maturation, blastocyst transfer and vitrification. Changes to culture media composition, stimulation regimes and laboratory protocols are also often established internationally without adequate validation. More recently, novel equipment that needs to be validated before it enters routine clinical use is being developed for IVF. With technologies such as producing gametes from stem cells around the corner, it is vital to ensure that the necessary research and development is conducted before bringing new techniques into clinical practice. Ideally, this should include preliminary work on animal models, such as mice/rats/rabbits/larger mammals, followed by studies on human embryos donated for research and finally well-designed RCTs with a follow up of all children born from the procedure. If such preliminary studies are not performed and published, it is possible that technology bringing no clinical benefit or leading to adverse health outcomes in the children born by these practices may be introduced. All IVF clinics need to consider the safety and efficacy of new technologies before introducing them.