Exposing IVF errors key to improving standard of care, say embryologists

Exposing IVF errors could be key to improving the standard of care, embryologists have said, after a California couple sued their fertility clinic over an embryo carrying a rare cancer gene.

Talking openly about IVF mix-ups could encourage increased regulation and make the treatment “safer”, experts have told Femtech World.

Jason and Melissa Diaz sued HRC Fertility, saying it allegedly implanted an embryo carrying a rare gene that causes deadly stomach cancer and then falsified records to cover up its mistake.

The couple said their son, now a year old, will require total stomach removal surgery as a young adult to prevent or treat the cancer.

Okan Atilan, senior clinical embryologist at Sidra Medicine hospital in Qatar, says while this type of errors are rare, IVF mix-ups can happen.

“It is important for such events to be talked about because we have the obligation to strive for even safer practices and constantly look for ways of improvement,” he explains.

“We need to identify where our precautionary systems may fail, so we can enhance them and take lessons from such reported cases.

“Clinics have the responsibility to be completely transparent to their patients about any non-conformance events and either prevent such mistakes from happening or take immediate action when a mistake is identified.”

A study published in 2020 found that between 2009 and 2019, out of approximately 2.5 million IVF procedures in the US, 133 errors happened that resulted in lawsuits.

However, Cynthia Hudson, embryologist and VP of clinical strategy at TMRW Life Sciences, says there is no US federal requirement for reporting errors and many cases are never brought to light.

“Cases are settled out of court and none of these are being systematically captured.

“IVF remains a viable option, but the number of errors quoted vs the number of cycles performed is low.

“There is no legal mandate for clinics to ensure systems are in place to provide an immutable audit trail for the entire specimen history and there is no federal requirement that clinics must report errors,” she continues.

“The lack of chain of custody – linking results to specimens – is exactly the reason this happened. Humans are fallible. Well meaning, but fallible.

“Ensuring complete chain of custody at the specimen level, with an immutable audit trail, is essential.”

Dr Cesar Diaz Garcia, medical director at IVI London, says in many fields, including IVF, human error is nearly always the culprit behind such incidents.

“During IVF, mix-ups can happen due to a dish containing gametes being incorrectly labelled, or laboratory technicians not following protocol.

“But it’s important to bear in mind that these cases are extremely rare because today, the tracking of gametes is mainly electronic.”

One possible path forward would be to develop international guidelines for IVF treatments to ensure they remain safe, ethical and effective and have universal consistency and transparency, says Atilan.

“Formation of local regulatory bodies should also be a priority,” he adds.

“These can be responsible for issuing licenses to clinics that provide fertility treatments as well as overseeing and regulating every aspect of fertility treatments and the use of gametes and embryos in research, providing statistics on success rates, investigating any reported violations and taking disciplinary action, as necessary.”