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

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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.”

Entrepreneur

Fertility startup American Baby Company secures US$4m

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A fertility startup has raised US$4m and will open its first lower-cost IVF clinic in West Palm Beach later this year.

It will offer a full IVF cycle, including medications, for US$8,995.

Around 12 per cent of American couples struggle with infertility, according to the company, but only 14 per cent of them receive IVF because of the cost.

A single IVF cycle costs an average of US$23,500, it said, with the cost nearly doubling if further cycles are needed.

Co-founder and chief executive Van Spina said: “We’re building ABC around a straightforward premise: IVF has become unnecessarily expensive, and many patients are priced out before they ever have a real chance to start a family.”

“This is personal for me. My fiancée and I went through IVF ourselves, including multiple failed cycles,” Spina continued, citing Jamie Rapp.

“That experience pushed me to build the kind of fertility company we wished had existed when we began treatment.”

The US$4m seed round was led by Wormhole Capital and Tower Research Ventures.

In a blog post, New York-based Tower Research described ABC as a new model for fertility care, praising its “evidence-based protocols, AI-assisted intake, and modern lab workflows.”

“When we met the team at The American Baby Company (ABC), we saw an opportunity to rethink how fertility care is delivered in the US from the ground up,” the post said.

Co-founder and chief medical officer Dr Paul Magarelli is a board-certified reproductive endocrinologist and one of the most prominent voices in the US on expanding access to fertility care, according to Tower.

Reproductive endocrinology is a branch of medicine concerned with hormones and fertility.

Magarelli developed the Clinical Fertility Physician certification programme, which trains generalist clinicians to deliver routine fertility procedures under specialist oversight.

Spina spent his early career as a technology investor at Warburg Pincus before founding an institutionally backed data business in private credit.

“We’re on a mission to become the place Americans go to start their families,” Spina said.

“Our 10-year goal is to help make 250,000 babies per year.”

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Entrepreneur

Onto Health acquires diagnostics software company Levy Health

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Onto Health has acquired Levy Health, a fertility software company providing precision diagnostics and patient intake for reproductive medicine.

The acquisition, fuelled by Onto Health’s US$20m Series A fundraise in April, supports its plan to build scalable, tech-enabled infrastructure for reproductive medicine.

Onto founder Roohi Jeelani, MD, called it the first of several moves in the company’s expansion strategy in a LinkedIn post, adding that there was “more coming soon”.

She said: “This isn’t just an acquisition, it’s proof of how we’re building Onto: physician-led, tech-enabled, and built to scale without losing the personal touch fertility patients deserve.”

Headquartered in Chicago, Onto Health combines evidence-based fertility care with artificial intelligence-driven diagnostics, clinical automation and longevity science.

AI-driven diagnostics use software to analyse patient information and support clinical decision-making, rather than replace clinicians.

Levy Health, founded in Berlin with US offices in San Francisco, helps medical providers identify endocrine disorders more quickly and helps clinics streamline fertility workups.

Endocrine disorders affect the body’s hormone system, which can influence ovulation, menstrual cycles and fertility.

Co-founder Caroline Mitterdorfer said joining Onto would expand Levy Health’s fertility care tools to more clinics and patients, helping physicians focus on patient care.

Onto opened its first clinic in Chicago in February, with plans for three more in the greater Chicago area.

The company said in April that it would use its new funding, led by Artis and Humania, to support additional operations in the US and expand into the Gulf Cooperation Council.

The Gulf Cooperation Council includes six Arab states bordering the Persian Gulf.

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Fertility

Softening ovaries could extend fertility as women age, study suggests

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Softening ageing ovaries could help women remain fertile for longer, early animal research suggests.

Fertility declines with age for several reasons, including poorer egg quality, fewer ovarian follicles and the gradual stiffening of ovarian tissue.

Existing fertility treatments, including hormone therapy and in vitro fertilisation, mainly address hormonal imbalances or help eggs mature or become fertilised.

Scientists are now examining whether changing the physical structure of the ovaries could provide another route for future fertility treatments.

Stuart A. Cook, of the Cardiovascular and Metabolic Disorders Programme at Duke-National University of Singapore Medical School, published an accompanying commentary on the research.

Researchers led by Shixuan Wang at Huazhong University of Science and Technology in Wuhan, China, collected healthy ovarian tissue from younger, middle-aged and older women.

They also examined samples from patients with polycystic ovary syndrome, known as PCOS, premature ovarian insufficiency, or POI, and endometriosis.

PCOS is a hormonal condition that can disrupt ovulation. POI occurs when the ovaries stop working normally before the age of 40, while endometriosis causes tissue similar to the womb lining to grow elsewhere in the body.

Tests of protein levels and gene activity found higher levels of the inflammatory protein interleukin-11, or IL-11, in ageing and diseased ovaries.

In laboratory experiments, the researchers exposed ovarian fibroblasts to IL-11. Fibroblasts are cells that produce connective tissue.

The protein caused the cells to produce excess collagen, a structural material that can build up during scarring and make tissue stiffer.

The researchers then genetically modified mice so they could not respond to IL-11. The animals developed less ovarian stiffening and maintained better ovarian function as they aged.

Similar results were seen in mouse models of PCOS and POI caused by chemotherapy.

In the final part of the experiment, older mice and rats were injected with a nanoparticle treatment containing small interfering RNA, or siRNA, designed to switch off IL-11.

The treatment made the animals’ ovaries less stiff and improved fertility.

Pregnancy rates among older mice rose from 25 per cent to 50 per cent, while average litter sizes also increased.

More rats treated with the therapy became pregnant and produced larger litters.

The approach remains highly speculative and will require considerably more research before its safety or effectiveness in women can be established.

However, the researchers said blocking the inflammatory pathway could eventually form the basis of new fertility treatments.

They said: “We propose that anti-IL-11 therapy represents a promising translational strategy for delaying ovarian ageing.”

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