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NICE issues fertility guidance for people with endometriosis

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NICE has updated fertility guidance with a new endometriosis section for people struggling to conceive.

This follows feedback received during public consultation, recognising for the first time that the condition requires its own tailored approach to fertility care, separate from other causes of infertility.

Emma Cox, chief executive of Endometriosis UK, said: “This year’s Endometriosis Action Month theme is ‘Endometriosis Doesn’t Wait’ and our new State of Endometriosis Care report shows just how urgently change is needed.

“With average diagnosis times now standing at 9 years and 4 months, and 11 years for those from ethnically diverse communities, many have already waited far too long by the time they reach fertility services.

Today’s guidance marks a step change in the fertility support that anyone with endometriosis should receive.

“For years, those with endometriosis have told us they felt invisible within the fertility system, grouped with unexplained infertility despite having a diagnosed condition.

“We welcome NICE’s decision to listen to patient voices during consultation, to create a dedicated pathway, and to remove misleading labels like ‘mild’ and ‘severe’ endometriosis.”

“Endometriosis doesn’t wait. And now, at last, neither will the guidance.”

Endometriosis UK and others told NICE during consultation that endometriosis was being grouped with unexplained infertility, despite it being a diagnosed condition.

The committee agreed this was inappropriate and that endometriosis requires a distinct fertility pathway.

Respondents also told NICE that terms such as “mild” and “severe” endometriosis were clinically ambiguous and did not reflect the complexity of the condition or its impact on fertility.

The committee agreed and those terms have been removed from the final guideline.

Under the new recommendations, clinicians will discuss a range of options with patients with endometriosis who are trying to conceive, taking into account individual factors including how long they have been trying to conceive, the severity of their symptoms, their age, their ovarian reserve, which is a measure of remaining egg supply, and any male fertility factors.

The guideline sets out a treatment pathway. Where appropriate, expectant management, meaning time to try to conceive naturally, may be offered, or surgical treatment to address endometriosis, in line with NICE’s existing endometriosis guideline (NG73).

If neither approach is suitable or successful after 2 years, fertility treatment options including intrauterine insemination (IUI), where sperm is placed directly into the womb, or IVF will be discussed.

The new guidance supports the ambitions set out in the NHS 10 Year Health Plan, which commits to shifting care closer to home and empowering patients and professionals to make the best choices about treatment.

Setting out a clear, personalised pathway in the guideline for endometriosis helps ensure fertility services are better tailored to individual need, reducing variation in care and supporting equitable access across England.

Eric Power, interim director of the Centre for Guidelines at NICE, said: “We listened carefully to what patients, clinicians and patient groups told us during consultation.

“They described how complex endometriosis is, how they felt existing labels were misleading, and that the condition needed its own pathway. The committee agreed and acted on that feedback.”

“By creating a dedicated section for endometriosis, we are giving clinicians a clear, evidence-based framework to have better, more personalised conversations with their patients, ensuring that everyone, regardless of the cause of their fertility problems, has access to the right care at the right time.”

Public health minister Sharon Hodgson said: “Every woman with endometriosis deserves fertility care that recognises the complexity of her condition.

“This landmark guidance will ensure women can access a clear, personalised pathway to fertility care that leads to clearer conversations with clinicians and fewer barriers.

“We’re committed to giving every woman the support she deserves, and today’s guidance is a significant step towards ending the inconsistency that has let down too many, for too long.”

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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Insight

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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Entrepreneur

Applications open for the third W Accelerate with Merck KGaA and M Ventures

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W Group has opened applications for W Accelerate with Merck KGaA and M Ventures, inviting reproductive and maternal health startups, scaleups and spinouts to pitch for direct access to global pharma partnership and strategic investment.

Selected companies will pitch on 5th October, competing for the chance to accelerate their growth through commercial partnerships, investment, or both.

This is the third time Merck KGaA, a global leader in reproductive health, has partnered with W Group on the programme, which exists to close the innovation and investment gap in women’s health by connecting the sector’s most promising startups directly with the corporates and investors positioned to scale them.

What Merck KGaA and M Ventures are looking for

This year’s call is focused on breakthrough solutions in female infertility, fertility preservation, adenomyosis, endometriosis, polyendocrine metabolic ovarian syndrome (PMOS), ovarian insufficiency, preeclampsia and pregnancy comorbidities.

New for this round, applicants choose between three pathways depending on what they need from the programme:

  • The Partnership Lane, for companies seeking commercial collaborations and strategic relationships
  • The Investment Lane, for founders looking to connect with investors and secure funding to scale
  • The Dual Lane, for innovators pursuing both partnership and investment opportunities

How the Accelerate event works

Selected companies get a 1:1 pitch practice session ahead of time, then a private 30-minute session with Merck KGaA and M Ventures leadership on the day itself, small-group sessions with regulatory and investment strategy experts, an “Ask Merck Anything” roundtable, and a VIP networking reception.

Key dates

  • Open call launches: 8th July
  • Open call closes: 2nd September
  • Notification of successful companies: 11th September
  • Pitch day: 5th October

Applications are open now at wplatform.typeform.com/to/KGzviBQM.

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