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UK regulator proposes to modernise 33-year-old fertility law

The new reforms aim to give the HFEA a range of regulatory tools to protect patients

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The Human Fertilisation and Embryology Authority has set out recommendations to modernise the UK’s 33-year-old fertility law.

The proposals made by the UK-wide regulator of fertility treatment and embryo research aim to “future-proof” the law, so it better reflects the significant changes in the size and structure of the fertility sector, in attitudes to fertility treatment and in medical and scientific developments.

The 15 proposals cover four areas where the law should be modernised in the interests of patients, professionals and researchers: patient safety and promoting good practice, access to donor information, consent and scientific developments.

The reforms aim to give the HFEA a range of regulatory tools to protect patients, helping the regulator decrease unnecessary regulatory burden and providing a greater focus on serious non-compliances.

With new technologies in the fertility space bringing potential new ethical issues, the proposals also aim to simplify consent for patients and modernise access to donor information.

“The current law does not reflect the range and type of fertility treatment on offer today, nor modern regulatory standards. We think there should be changes that will ensure the law can continue to effectively protect patients, as well as support the scientific advances that can help them have a much-wanted child,” said Julia Chain, chair of the HFEA.

“The number of patients having fertility treatment has increased from just over 6000 in 1991 to nearly 52,000 in 2021. The fertility sector has also changed, leaving our current regulatory powers out of step with patient expectations and regulatory standards.

“Today, most patients fund their treatment themselves, which has changed their view of this area of healthcare to being consumers with active choices to be made. Many UK regulators have a wider and more effective range of powers to improve compliance and protect patients and consumers than those available to the HFEA.”

She added: “Our proposals would improve patient safety and protection and maintain the UK’s position as a country where scientific and clinical innovation can flourish.

“In all our work, the special status of the human embryo will remain a guiding principle as its potential makes it different from all other human tissue.”

The recommendations were developed by the HFEA after seeking the views of fertility patients, clinic staff and others interested in the area via a public consultation.

Chain said: “The full consultation report, which shows the range of views we received, was extremely helpful in developing the recommendations.

“Nowhere in this field has the pace of social and technological change been more rapid than in the growing popularity of direct-to-consumer DNA testing and social media, with a lasting impact on donor anonymity. We need to balance the law with what is taking place in reality.

“We recommend the law is changed so that parents can find out who a donor is from the birth of a child. Our proposal reflects the fact that the current system, where identifiable information about a donor is disclosed to the donor-conceived person at 18 and only upon request, can no longer effectively keep up.

“We know this a significant departure, and so a gradual approach to reach this position may be best, but it should be the aim to future proof the law,” she added.

Insight

Topical HRT protects bone density in women with period loss – study

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Transdermal HRT best protects bone density in women with functional hypothalamic amenorrhoea, a condition that stops periods, a review of trials has found.

The meta-analysis pooled randomised clinical trials involving 692 participants and found transdermal hormone replacement therapy and teriparatide increased bone mineral density by between 2 and 13 per cent.

Functional hypothalamic amenorrhoea can follow anorexia or intense exercise. Bone mineral density measures bone strength and the amount of mineral in bone.

Around half of women with the condition have low bone mineral density, compared with about 1 per cent of healthy women, and their fracture risk is up to seven times higher.

The research was conducted by scientists at Imperial College London and Imperial College Healthcare NHS Trust.

Professor Alexander Comninos, senior author of the study and consultant endocrinologist at the trust, said: “Bone density is lost very rapidly in FHA and so addressing bone health early is very important to reduce the lifelong risk of fractures.

“Our study provides much needed comparisons of all the available treatments from all available studies.

“Clearly the best treatment is to restore normal menstrual cycles and therefore oestrogen levels through various psychological, nutritional or exercise interventions – but that is not always possible.

“The foundation for bone health is good calcium and vitamin D intake (through diet and/or supplements) but we have additional treatments that are more effective.”

When FHA is diagnosed, clinicians first try to restore periods through lifestyle measures, including psychological and dietary support, but these can fail. Guidelines then recommend giving oestrogen, though the best form was unclear.

The team reviewed all prior randomised trials comparing therapies, including oral and transdermal oestrogen, and also assessed teriparatide, a prescription bone-building drug used for severe osteoporosis.

They found no significant benefit for oral contraceptive pills or oral hormone therapy.

A recent UK audit reported that about a quarter of women with anorexia-related FHA are prescribed the oral contraceptive pill for bone loss; the study suggests using transdermal therapy instead.

Comninos said: “Our goal is simple: to help women receive the right treatment sooner and to protect their bone health in the long-term.

“We hope this study provides clinicians with better evidence to choose transdermal oestrogen when prescribing oestrogen and so inform future practice guidelines.

“Right now, millions of women with FHA may not be receiving the best treatments for their bone health.”

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AI cuts interval breast cancers in Swedish trial

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An AI tool cut interval breast cancers by 12 per cent in a Swedish screening trial of more than 105,000 women.

The study also found 27 per cent fewer aggressive breast cancers detected at screening when AI was used.

Interval cancers are cancers found between routine screening appointments because they were missed at the original scan. They are often more dangerous and linked to higher death rates than cancers found at screening.

The MASAI trial is described as the first large randomised study to test whether AI can improve mammography screening, which uses low-dose X-rays to examine breast tissue for signs of cancer.

The AI tool, called Transpara Detection and developed by ScreenPoint Medical, supported radiologists in analysing mammography images.

Earlier results from the same trial showed that Transpara Detection increased cancers found by 29 per cent and reduced radiologist workload by 44 per cent compared with standard double-reading, where two radiologists independently review each scan.

The latest findings indicate higher accuracy with AI support. Sensitivity, the ability to detect cancer, was 6.7 percentage points higher in the AI group while specificity, the ability to rule out healthy cases, was maintained. Results were similar across age groups and breast density levels.

Women screened with AI had 16 per cent fewer invasive interval cancers and 21 per cent fewer large interval cancers than those in the standard screening group.

The system also helps doctors assess risk more precisely by subdividing suspicious findings into BI-RADS 4 categories A, B and C. BI-RADS (Breast Imaging Reporting and Data System) is a standardised scale that guides whether a patient needs closer monitoring, further tests or treatment.

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Mental health

Fear of ageing may age women faster, study suggests

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Ageing anxiety may accelerate biological ageing in women, with fears about worsening health linked to faster epigenetic ageing, according to new research.

The study found that greater anxiety about growing old was associated with accelerated epigenetic ageing, as measured by the DunedinPACE clock, based on biological markers in blood samples.

Epigenetic changes are shifts in how genes are switched on or off without altering DNA itself, which can influence how the body ages and functions.

“Our research suggests that subjective experiences may be driving objective measures of ageing,” said Mariana Rodrigues, a PhD student and the first author of the study.

“Ageing-related anxiety is not merely a psychological concern, but may leave a mark on the body with real health consequences.”

Researchers analysed data from 726 women in the Midlife in the US study.

Participants were asked how much they worried about becoming less attractive with age, having more health issues and being too old to have children.

Blood samples were used to assess ageing with two epigenetic clocks: DunedinPACE, which estimates the pace of biological ageing, and GrimAge2, which estimates cumulative biological damage.

The study was conducted by researchers at NYU School of Global Public Health.

Worrying about declining health showed the strongest links with epigenetic ageing, while anxiety about attractiveness and fertility was not significantly associated with biological markers.

The authors suggest health worries are more common and persist over time, whereas concerns about appearance and reproduction may fade with age.

“Women in midlife may also be multiple in roles, including caring for their ageing parents,” Rodrigues said.

“As they see older family members grow older and become sick, they may worry about whether the same thing will happen to them.”

The authors caution that the study offers a snapshot in time and other factors may influence these biological changes.

When analyses were adjusted for health behaviours such as smoking and alcohol use, the link between ageing anxiety and epigenetic ageing decreased and was no longer significant.

“Our research identifies ageing anxiety as a measurable and modifiable psychological determinant that seems to be shaping ageing biology,” said Adolfo Cuevas, associate professor of social and behavioural sciences and the study’s senior author.

They call for more research to clarify how this anxiety influences ageing over time, to guide support for those experiencing ageing anxiety.

“Ageing is a universal experience.” Rodrigues said.

“We need to start a discourse about how we as a society, through our norms, structural factors and interpersonal relationships, address the challenges of ageing.”

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