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Fairtility’s AI decision-support tool granted CE mark under new MDR

CHLOE EQ™ is the first AI-powered tool for embryo classification and selection to achieve CE MDR approval

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Fairtility’s AI decision-support tool CHLOE EQ™ has earned the CE Mark under the European Medical Devices Regulation (MDR) regulatory requirements and is now commercially available to fertility clinics across Europe.

CHLOE EQ™ is an AI decision-support tool that was developed to provide embryo viability assessment which supports the prediction of blastulation, the prediction of implantation and ploidy and ranks embryos in order of priority.

It provides automatic annotations for morphokinetic and PN count which support fertilisation assessment.

According to Dr. Cristina Hickman, Fairtility VP of Clinical Affairs and leading embryology expert, embryo evaluation and selection has traditionally been a manual process, limiting patient access to treatment while also opening the door for human error.

“One of the key advantages that CHLOE EQ™ was designed to offer is accuracy and consistency in assessment,” she adds. “CHLOE’s proprietary AI-based algorithms become more accurate the more data it gathers, leading to uniform and accurate embryo assessment.”

The information provided by CHLOE EQ™ can then assist embryologists and IVF professionals in the decision of prioritising the most viable embryo for treatment, especially when there are multiple embryos deemed suitable.

The tool is designed to add efficiency to embryologists’ workflow, automating manual steps, including annotation of each embryo and written daily observations into each patient’s electronic medical record (EMR).

Embryologists verify the system’s automatic annotations that are then immediately integrated from the Time Lapse Incubator (TLI) directly into the EMR.

Eran Eshed, CEO and Co-Founder of Fairtility, says that: “Having gained regulatory acknowledgement in Europe, under the more stringent directive that the CE MDR provides, we are now commercially launching CHLOE EQ™ in clinics across the EU while continuing to uphold the highest standard of this classification.

“With the EU IVF market size estimated to reach over $2 billion by 2027, we see tremendous opportunities to demonstrate the clinical efficacy and impact of CHLOE EQ™ ahead of US market entry.”

The European MDR came into effect in May 2021 and serves as the new European legal framework for medical devices. MDR has more stringent requirements for demonstrated compliance, vis a vis the obsolete Medical Device Directive (MDD), the previous industry standard.

Fairtility is showcasing CHLOE EQ™ at the 38th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE), taking place in Milan Italy from July 3-6, 2022 with five oral presentations and seven posters supporting the clinical impact of the product.

In vitro fertilisation (IVF) is the most effective form of assisted reproductive technology. Due to the complexity of the procedure, however, prediction of embryonic implantation prior to IVF is key in decision-making.

The Israeli software company Fairtility aims to maximise IVF outcomes by using AI and computer vision algorithms to provide early, data-driven embryo quality.

For more info, visit fairtility.com.

Fertility

Fertility: The fear, grief and relief in accessing mental health support

90 per cent of those struggling to conceive are likely to experience depression symptoms of some kind

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As research shows that women with infertility experience similar levels of anxiety and depression to those with cancer, heart disease and HIV, we find out how to get the balance right when trying to conceive.

The relationship between stress and infertility has been repeatedly debated. Although the impact of distress on treatment outcome is unclear, stress, depression and anxiety are common consequences of infertility.

According to NICE, one in seven heterosexual couples in the UK may have difficulty conceiving. But despite the prevalence of infertility, research has shown that couples often shy away from sharing their story and “fake good” in order to appear mentally healthier than they are, thus increasing their psychological vulnerability.

“The lack of scientific knowledge has meant that the correlation between fertility and mental health support has been largely ignored,” says Mithi Thaya, CEO of the London-based health tech company Harper.

“Women who undergo fertility treatment are highly stressed. However, in most cases, nobody looks after their mental well-being because the clinicians and nurses either don’t have the time or are not well equipped to do so.”

A Fertility Network UK survey on the impact of fertility problems found that only 44 per cent of women received counselling with 54 per cent of them funding some of the sessions themselves.

Existing solutions are often too costly for clinics to implement, says Thaya. “In order to offer counselling, a clinic has to go through both a fertility and a reproductive medicine regulator.

“On top of that, self-reporting – the current gold standard in mental health assessment – can be unreliable simply because people may not be aware of certain mental health issues they might have.”

Along with the team behind Harper, Thaya aims to make mental healthcare more objective and affordable through molecular biology and technology for earlier accurate detection.

The practice, also known as precision medicine, looks at the genetics, environment, and lifestyle of a person and offers a personalised treatment, in contrast to the traditional one-size-fits-all approach to prevention and care.

Reports have shown that giving the right treatment to the right person at the right time leads to better outcomes for patients and can additionally reduce the costs and the risk of adverse effects.

“Your behaviour, your tone of voice, your eye pattern, some of the hormones you produce in your body and the way you feel could be indicators of your state of mental health,” the CEO explains.

“So, we aggregate all of these data points in a seamless, non-invasive manner through a number of clinically validated digital assessments, we give each patient a personalised plan and then we assign them a fertility-trained coach.”

Coaches help couples learn to express their feelings, navigate their IVF cycles and feel more in control. However, a coach is not a counsellor, says Thaya.

“There’s a big difference between our coaches and having a counsellor. Counselling often helps with serious issues, including severe mental health challenges and trauma. But although therapy has its place, when it comes to fertility treatment, we realised that the last thing a patient wants is somebody to open the Pandora’s box of everything that has been going wrong in their life.

“Coaching, on the other hand, is there to help them achieve their goal. The coaches are either IVF nurses or patient administrators who have previously worked in an IVF setting and are able to deal with patients on a human level.”

Demand for mental health support has significantly increased post pandemic. Reports have found that 90 per cent of those struggling with fertility are likely to experience depression symptoms of some kind while 42 per cent are likely to report suicidal thoughts.

However, the mental health sector remains unexplored. Meta analyses have shown that mental health has received “an inadequate proportion of health funding”, in comparison with the burden it causes while stigma, human resource shortages, fragmented service delivery models and a lack of research capacity for implementation and policy change contribute to the current treatment gap.

Thaya hopes that by working with scientists companies like Harper will drive more research and investment in solutions targeting mental health.

“We are very fortunate to partner with experts from the University of Chicago, Oxford, Cambridge and Imperial College London and our goal is to do a joint study with them to analyse the data from the clinics we work with and improve patient support.”

After in April it raised US$6.5m to address AI-based mental healthcare, the start-up is planning to expand geographically and explore other health sectors, including cardiovascular disease and oncology.

“We know that people who live with different mental health conditions, such as chronic stress, clinical anxiety or depression, have a two times higher rate of cardiovascular disease,” says Thaya.

“Our ambition is to be able to identify patients’ state of mental wellbeing at the right time and deliver the right interventions.”

 

 

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UNFPA appeals for £10.7 million for critical women healthcare in Sri Lanka

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UNFPA, the United Nations Sexual and Reproductive Health Agency, has launched an appeal to deliver better healthcare to women in Sri Lanka.

The appeal aims to deliver lifesaving healthcare to more than two million women and girls in Sri Lanka in the next six months, as the country is experiencing its worst socio-economic crisis since independence.

A lack of medical equipment and medicine is causing a collapse in the medical system which is having a severe impact on the delivery of reproductive and sexual health services. This includes maternity care and access to contraception.

The UNFPA reports that protection mechanisms for girls and women in need have also been severely compromised.

“The current economic crisis in Sri Lanka has far-reaching consequences for women and girls’ health, rights and dignity,” said Dr. Natalia Kanem, UNFPA executive director. “Right now, UNFPA’s priority is to respond to their unique needs and safeguard their access to lifesaving healthcare and protection services.”

The UN agency estimates that 60,000 pregnant Sri Lankan women may require surgical interventions over the next six months. 

In response to this, UNFPA plans to distribute medicines, equipments and supplies to meet the health needs of 1.2 million people.

It will also provide more than 37,000 women with cash and voucher assistance for reproductive health and protection services; ensure that 500,000 women receive information on warning signs during pregnancy; and strengthen the capacity of 1,250 midwives.

“UNFPA is committed to meeting the critical health and protection needs of women and girls,: said Kunle Adeniyi, UNFPA representative in Sri Lanka. “Our focus is to strengthen sexual and reproductive health and gender-based violence response services to reduce the long-term repercussions of the the current crisis.”

Sri Lanka is currently experiencing its worse socio-economic crisis since gaining independence in 1948. 

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Nike launches online maternity training programme

The athletic giant aims to help new mums get back into sport

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Nike has revealed a global maternity training programme, amid high rates of dropout from exercise due to pregnancy.

The new Nike Training Club app programme features a prenatal and postpartum exercise plan with 24 workouts that include strength, cardio, mobility and yoga movements.

The company said the workouts were designed by qualified trainers and vetted by a panel consisting of five pregnancy experts, as well as an OB/GYN, covering early pregnancy, later pregnancy and postpartum.

Additionally, the programme includes a six-week deep core and pelvic floor recovery plan designed by a pelvic health physical therapist, safe to start in the early days after delivery.

The training club also covers topics like exercising during fertility treatment, eating well throughout pregnancy, exercising when breastfeeding as well as guided runs tailored to each trimester.

According to research from the OB/GYN Online Library, pregnancy is the second most common reason why people quit exercising.

Because pregnancy is such an intense transitional period in a person’s life — physically, mentally, and emotionally — exercise may not be a priority for many.

However, physical activity during pregnancy has been shown to have a monumental effect on the parent’s health, delivery, and overall parenthood.

Although the Nike programme highlights the company’s latest effort to provide prenatal and postpartum support, the giant has been previously criticised over alleged unfair policies around pregnancy and pay fairness.

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