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Fertility drug improves live birth rates in women undergoing IVF

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New research has demonstrated the effectiveness of a non-hormonal drug in increasing embryo implantation, pregnancy and live birth rates among women undergoing IVF and ICSI.

The findings, presented at the ESHRE 40th annual meeting in Amsterdam, represent a significant step toward the first therapeutic tool to increase embryo implantation and live birth rate success.

Worldwide, one in six people of reproductive age experience infertility in their lifetime. Over three million IVF cycles are performed annually and yet, despite advancing IVF technologies, embryo implantation failure remains a significant challenge.

In response to this unmet need, researchers have unveiled the promising findings of their Phase 2 clinical trial, OXOART2. The trial, conducted across 28 centres in Europe, evaluated OXO-001, a drug that acts directly on the endometrium to improve embryo implantation and pregnancy rates.

The study analysed 96 women aged up to 40 years old who underwent a single embryo transfer, 42 receiving placebo and 54 receiving a daily dose of OXO-001. Treatment began one menstrual cycle before the embryo transfer cycle and continued until five weeks after the transfer.

Statistically significant improvements were observed in biochemical pregnancy rates – an early detection of pregnancy – with rates of 75.9 per cent in the OXO-001 group compared to 52.4 per cent in the placebo group.

Clinically relevant improvements were also seen in clinical pregnancy rates and in ongoing pregnancy rates, being a +14.3 absolute increase (50.0 per cent for OXO-001 vs. 35.7 per cent for placebo) and a +10.6 absolute increase (46.3 per cent for OXO-001 vs 35.7 per cent for placebo) respectively.

Most importantly, there was an absolute increase of +6.9 in live birth rates (42.6 per cent for OXO-001 vs. 35.7 per cent for placebo).

Dr Agnès Arbat, OXOLIFE’s CEO and CMO, said: “From scientific societies, key opinion leaders, clinicians and patients, we know that an absolute increase of more than five percentage points in ongoing pregnancy is considered clinically meaningful.

“We observed an increase higher than +9, giving renewed hope to patients and the scientific community. We look forward to advancing this promising treatment through the next phases of clinical development.”

The occurrence of side effects was similar in both groups. The most common side effects were headaches, nausea, vomiting, gastrointestinal issues and dizziness, most of which were mild to moderate.

In the six-month follow-up, the babies indicated good development with no differences with placebo, the research showed and overall, OXO-001 was well tolerated.

Dr Ignasi Canals, CSO of OXOLIFE said: “We are thrilled with the results of this trial, which highlight OXO-001’s potential to become the first therapeutic treatment to increase embryo implantation success, with a non-hormonal drug using a new mechanism of action, acting directly on the endometrium.”

Professor Dr Karen Sermon, chair of ESHRE, added: “Despite continuous developments in ovarian stimulation, embryo manipulation and culture, improving live birth rates in medically assisted reproduction has been incremental at best.

“A jump of nearly seven per cent is very good news for our patients, and hopefully this can be confirmed in larger patient groups.”

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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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