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Novel PCOS treatment shows ‘great promise’ in clinical trials

The Ovarian Rebalancing treatment aims to lower androgen production through targeted ovarian ablation

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A French medical device company has unveiled promising clinical trial results for a “novel” polycystic ovary syndrome treatment.

May Health has announced preliminary data supporting the safety and effectiveness of its Ovarian Rebalancing treatment for inducing ovulation in women with PCOS-related infertility at the this year’s ESHRE meeting in Copenhagen.

The company has received the US FDA’s approval of its REBALANCE study, designed to evaluate the safety and effectiveness of Ovarian Rebalancing in women with PCOS-related infertility.

PCOS is a common condition affecting around one in 10 women in the UK.

Women with PCOS may experience symptoms such as irregular periods, high levels of “male” hormones, known as androgens, and a cystic appearance of the ovaries on ultrasound caused by the ovarian follicles becoming arrested in their development towards releasing an egg.

The “novel” one-time treatment aims to lower androgen production, which can often restore ovulation, through targeted ovarian ablation.

Saad Amer, professor of gynaecology and reproductive medicine at the University of Nottingham and lead investigator, said: “Infertility is an emotional journey, and current options available to achieve pregnancy are often expensive, invasive, and do not work for all women, adding burden to the experience.

“The new data shows great promise for Ovarian Rebalancing as a safe and effective office-based treatment to induce ovulation in women who have not achieved results from first-line medications.”

To date, a pregnancy rate of 35 per cent was observed for the 23 participants who received Ovarian Rebalancing and completed six months of follow-up, including some patients who re-started first-line ovulation induction medication between three and six months, the trials found.

Results showed 44 per cent of women ovulated spontaneously during the first three months after undergoing Ovarian Rebalancing.

The trials also showed the ovulation rate increased to 65 per cent between three and six months, with the re-introduction of first-line medication at three months post procedure.

In 100 per cent of patients, ablation was achieved successfully in at least one ovary, the studies found, with 84 per cent of patients receiving the targeted ablation in both ovaries.

No serious adverse events related to the device were reported. The most common adverse events related to the procedure were mild and included vaginal bleeding, pain, and headache.

Anne Morrissey, CEO of May Health, said: “In addition to being the leading cause of infertility, PCOS causes other major health challenges and women lack options to address the needs of this disorder.

“Our team recognises the need for innovative treatments for PCOS, and the data from our trials show that Ovarian Rebalancing has the potential to shift the treatment landscape for this patient population.

“We are eager to continue our research with the US pivotal trial and explore additional endpoints in future studies to assess the potential of Ovarian Rebalancing as a treatment for other symptoms of PCOS.”

Antoine Papiernik, chairman and managing partner of Sofinnova Partners, said: “The inception of May Health within our medtech accelerator was fuelled by a firm belief in the transformative potential of its technology.

“The success of these feasibility studies and the FDA’s approval of the pivotal REBALANCE study only serve to reinforce our initial conviction. We look forward to seeing this technology revolutionise the field of infertility treatment.”

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‘Long waiting lists and patchy care provision’- NHS-funded IVF cycles fall to 14-year low

NHS-funded IVF procedures dropped to 27 per cent in 2022 from 40 per cent in 2012, new data shows

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The proportion of NHS-funded IVF cycles in the UK has fallen to the lowest level for 14 years, leaving fertility patients either unable to access treatment or forced to go private.

Some 27 per cent of IVF cycles were funded by the NHS in 2022, the lowest figure since 2008 and a sharp fall on the 40 per cent which it provided in 2012, according to the latest annual report by the Human Fertilisation and Embryology Authority (HFEA).

The number of NHS-funded cycles of IVF fell by 17 per cent in England, 16 per cent in Wales and seven per cent in Scotland between 2019 and 2022, the report showed. The East Midlands of England saw the biggest fall during that time, down 48 per cent.

The regulator said the fall may be being fuelled by the rise in NHS waiting lists, meaning it is taking longer for many patients to see a specialist in the first place.

Such delays can mean that women seeking help with fertility lose their window for treatment, as the chances of success fall.

Julia Chain, chair of the HFEA, said: “Our data shows the average age of patients starting treatment for the first time is now nearly six years older than the average age at which women in England and Wales gave birth to their first child.

“There are several possible factors for this including the knock-on effect of delays across the NHS due to the COVID-19 pandemic, particularly in gynaecology, which has likely led to delays in some patients accessing fertility services.”

The higher average age, Chain said, may also relate to difficulty in funding fertility treatment, owing to recent increases in the cost of living, a fall in the proportion of NHS-funded IVF cycles and increased waiting times for further investigations before accessing NHS-funded treatment.

Leila Thabet, general manager at Maven Clinic, told Femtech World: “Today’s figures highlight what many of us working in the field of women’s health have known for some time – fertility treatment is extremely challenging to access on the NHS.

“NHS IVF treatment is subject to long waiting lists and patchy care provision, often with inadequate support for the emotional toll the treatment takes.

“Women undergoing IVF will all need different types and levels of support as every IVF journey is different. This personalised treatment is not something the NHS is set up to provide, so even where women are lucky enough to benefit from NHS fertility treatment, they may need to turn to other providers for additional physical and emotional support.”

She added: “Women going through IVF often describe it as all consuming. It impacts every aspect of your life – physically, emotionally and practically. Juggling IVF treatment and a career are notoriously hard, for example. Add the huge financial toll, and we can clearly see why fertility treatment is life changing in every sense, no matter the outcome.”

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Future Fertility and IVI RMA Global Research Alliance forge landmark commercial partnership to raise standard of care in egg quality assessment

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Future Fertility, the leader in AI-powered oocyte quality assessment, and IVI RMA Global, the world’s leading reproductive medicine group, are excited to announce their new strategic commercial partnership.

Under this landmark agreement, Future Fertility’s VIOLET™ tool will be integrated into every egg freezing cycle at IVI RMA’s clinics across Europe and Latin America. Both companies will also collaborate to determine how this technology can be used to assess donor egg quality to provide greater transparency and precision in egg donation treatments.

IVI RMA is renowned for its scientific leadership and adoption of cutting-edge technology to advance patient care. This collaboration marks IVI RMA’s first large-scale AI technology partnership and is the most extensive clinic network partnership to date for Future Fertility.

Future Fertility has rapidly gained adoption within the fertility industry, with its oocyte assessment tools installed in over 100 clinics across more than 25 countries. Its seamless integration with various laboratory setups, from time-lapse to microscope-only environments, and unparalleled patient-facing oocyte quality reports have been the drivers of this momentum.

As the company’s dataset has grown to over 150,000 oocyte images and associated reproductive outcomes, the adoption of these tools is driving the creation of a standard of care for oocyte quality assessment.

“Future Fertility’s AI tools allow our clinics to evaluate oocyte quality with an unprecedented level of objectivity and data-driven precision,” said Prof. Laura Rienzi, head of innovation at IVI RMA.

“Their dedication to thorough clinical validation and peer-reviewed scientific publications provides us with evidence that these tools hold the potential to improve our lab processes, treatment planning and patient experience across our network.”

“Partnering with IVI RMA is an incredibly exciting milestone for us,” said Christy Prada, CEO of Future Fertility.

“This is a true testament to the value of our oocyte reports from an extremely prestigious leader in clinical care, and a strong validation of our scientific approach from the largest clinical network in fertility care globally.”

Empowering egg freezing patients with personalised insights

Historically, fertility specialists estimated an egg freezing patient’s chance of success based on age and the number of mature eggs retrieved.

Future Fertility’s deep learning model personalises fertility care by evaluating each egg’s unique likelihood of developing into a blastocyst based on its image. VIOLET™ reports also provide each patient with their personal chance of achieving a live birth from the eggs they’ve frozen.

Dr Antonio Requena, IVI RMA’s group medical director, emphasised the impact on patient care: “These individualised insights allow our clinical team to customise treatment plans to each patient’s specific needs, offering essential clarity on treatment expectations and improving patient counselling for future steps.”

“The current standard of care in reproductive medicine includes standardised methods to evaluate sperm, embryos, and the endometrium – but not the egg,” says Dr Dan Nayot, chief medical officer and co-founder at Future Fertility.

“Our team has been able to address this gap with AI so that patients and their fertility care teams can be empowered with precise information to make more-informed decisions along the path to parenthood.”

Long-term scientific partnership and expanded commercial collaboration

IVI RMA, ever committed to the scientific advancement of reproductive medicine, first began utilising Future Fertility’s tools in egg quality-focused research at its leading clinics in Spain in 2022.

Dr Marcos Meseguer, scientific director at IVI Valencia, highlighted the benefits of these tools in driving new avenues for investigation: “Future Fertility’s oocyte AI has created the opportunity for us to study and better understand the impact of different clinical approaches on egg quality.

“As the first player to develop this type of solution, they are paving the way for the industry to evolve thinking on the role of egg quality in treatment plans.”

His team presented their scientific findings at last year’s American Society of Reproductive Medicine conference in New Orleans, confirming the ability of VIOLET™ to predict fertilisation, blastocyst and live birth outcomes from oocyte images taken within the lab.

Other IVI RMA clinics under the GINEFIV, GINEMED and GENERA brands have been using VIOLET™ and MAGENTA™ in their scientific research for the past year and a half, assessing the role of AI in evaluating donor egg quality, enhancing transparency for recipients, and optimising donor egg screening.

“We were early believers in the importance of oocyte quality with respect to reproductive success,” said Dr Danilo Cimadomo, director of innovation in embryology at IVI RMA Italia.

“Future Fertility’s AI tools hold potential for improving our research projects by bringing objectivity into our efforts to better understand egg donor cycles.”

The progression of this enduring partnership from experimental roots to commercial adoption is indicative of the growing affirmation of Future Fertility’s technology worldwide.

Rafael Gonzalez, head of global sales and commercial strategy at Future Fertility, commented: “Our commercial traction has been remarkable across the countries we operate in.

“This new partnership with IVI RMA Global is the culmination of our long-time collaboration and is now empowering patients globally with more precise insights into their fertility treatment options.”

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Women with endometriosis face fourfold higher risk of ovarian cancer, study finds

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The risk of developing ovarian cancer could jump about fourfold among women with endometriosis compared with women without the condition, a new study has found.

A landmark study from researchers at the University of Utah and Boston University Chobanian & Avedisian School of Medicine found that women with severe endometriosis are 10 times more likely to get ovarian cancer compared to women who do not have the disease.

Prior studies have shown a causal connection between endometriosis and ovarian cancer but in using the Utah Population Database, a repository of linked health records housed at Huntsman Cancer Institute at the University of Utah, investigators were able to analyse the incidence rates of different types of endometriosis and subtypes of ovarian cancer for the first time.

Their research, which included a cohort of over 78,000 women with endometriosis, found that women with severe forms — either deep infiltrating endometriosis, ovarian endometriomas or both — have an overall ovarian cancer risk that’s “markedly increased,” at about 9.7 times higher, relative to women without endometriosis.

Women with deep infiltrating endometriosis, ovarian endometriomas or both, on the other hand, appear to face nearly 19 times the risk of type I ovarian cancer, which tends to grow more slowly, compared with women without endometriosis, according to the study.

In their calculations, researchers also found that women with any kind of endometriosis have a 4.2-fold risk of developing ovarian cancer compared to those who do not.

“These are really important findings,” said Jennifer Doherty, investigator and professor of the population health sciences department at the University of Utah.

“This impacts clinical care for individuals with severe endometriosis, since they would benefit from counselling about ovarian cancer risk and prevention.

“This research will also lead to further studies to understand the mechanisms through which specific types of endometriosis cause different types of ovarian cancer.”

However, women with endometriosis should not panic about the findings, researchers noted, because ovarian cancer itself is still rare. About 1.1 per cent of US women will be diagnosed with ovarian cancer at some point in their lifetime, according to the National Cancer Institute.

“Because of the rarity of ovarian cancer, the association with endometriosis only increased the number of cancer cases by 10 to 20 per 10,000 women,” Karen Schliep, senior author of the study and an associate professor in the Division of Public Health at the University of Utah School of Medicine, told CNN.

“We would not recommend, at this point, any change in clinical care or policy. The best way of preventing ovarian cancer is still the recommendation of exercise, not smoking and limiting alcohol.”

Women with endometriosis could pursue surgeries, such as hysterectomies or removal of the ovaries, investigators said. However, since these are invasive procedures, more research is needed to know if these are the right measures, they concluded.

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