Insight
Round up: Trial to evaluate ovarian cancer drug candidate and more
Femtech World explores the latest research developments in the world of women’s health.
Fertility treatments linked to higher mutations than natural conception
Mice that were conceived with IVF in the lab have slightly increased rates of DNA errors, or mutations, compared to pups conceived naturally, a new study suggests.
While the results do not directly apply to humans, they highlight the importance of understanding how fertility treatments affect an offspring’s DNA.
The researchers compared genome sequences of lab mice conceived naturally and mice conceived through assisted reproductive technologies, including hormone treatments, IVF, and embryo transfer.
They discovered pups born through these fertility treatments had about 30 per cent more new single-nucleotide variants, or tiny changes in DNA sequences.
Nucleotides are DNA’s building blocks or “letters.” Arranged in specific sequences, these letters compose the instructions cells use to grow and function.
Single-nucleotide variants are simply genetic differences (or mutations) involving a change in just one DNA letter. They can occur when cells replicate their DNA.
The mutations observed in the study are unlikely to be harmful.
Scientists estimate that fewer than 2 per cent of new mutations arising in a genome are deleterious or have an impact on an individual’s phenotype or disease susceptibility, the researchers said.
The mutations appeared spread across the genome, rather than clustered in particular genes.
The timing of when these new mutations appeared in early embryos also looked similar between fertility-treated and natural groups, implying that fertility treatment increases the overall chance of new DNA changes but does not impact when they occur during development.
Even with a 30 per cent increase in new mutations, the absolute number of harmful new mutations per mouse remains low.
For about every 50 mice conceived with IVF, scientists expect roughly one additional harmful DNA change compared to natural conception.
That is one problematic change out of many possible ones, since the mouse genome is about 2.7 billion DNA letters long.
A similar effect is expected if the male parent’s age increased by about 30 weeks, since paternal age is a major driver of mutation rates in mammals.
The biological mechanisms underlying these genetic changes are not clear.
Further research is needed to study whether the new mutations come from a specific step in the IVF process or from the combined effects of several steps.
One possible factor is the use of hormone treatments that stimulate the ovaries, since these hormones push eggs to restart meiosis, a stage of cell division known to be prone to mistakes.
Other aspects of the fertility treatment protocol could also play a role, such as physical handling of embryos or the chemical conditions of the lab culture environment.
The study does not show whether the same effect happens in humans. Fertility procedures vary between mice and humans, and both have different reproductive biology.
For example, mice do not menstruate. Also, people seeking IVF will likely encounter environmental factors that may already have affected their genetics.
First patient enrolled in study evaluating sofetabart mipitecan in recurrent ovarian cancer
The GOG Foundation has announced the enrollment of the first patient in GOG-3133, a Phase 3 clinical trial evaluating sofetabart mipitecan in recurrent ovarian cancer.
Sofetabart mipitecan is a novel folate receptor alpha-targeting antibody-drug conjugate featuring an exatecan payload.
In early-phase studies, sofetabart mipitecan demonstrated robust and durable clinical activity with an ORR of 50 per cent among 104 heavily pre-treated patients with platinum-resistant ovarian cancer (PROC), across all range of FRα expression levels, and in patients previously treated with mirvetuximab soravtansine with negligible rates of interstitial lung disease and peripheral neuropathy and no ocular toxicity or alopecia.
This clinical trial, sponsored by Eli Lilly and Company, has two parts; it tests a potential new medicine called sofetabart mipitecan for people with certain types of ovarian, peritoneal, and fallopian tube cancers.
Part A looks at participants whose cancer no longer responds to platinum-based chemotherapy (platinum resistant).
Part B looks at participants whose cancer has a higher chance of responding to platinum-based chemotherapy (platinum sensitive).
The FRAmework-01 study aims to address the need for more effective therapies in both platinum-resistant and platinum-sensitive ovarian cancer.
Young people in Wales to receive new information about women’s health
The Women’s Health Network has worked with school nurses and learners across Wales to develop resources for women’s health.
Girls and boys contributed to ensure they reflect the information young people need.
The resources, which were launched this week by the Minister for Mental Health and Wellbeing, Sarah Murphy, cover 4 key areas including menstrual health, endometriosis, pelvic health, and menopause.
Secondary schools will be able to adapt the resources to include their own branding.
The materials work across multiple platforms, including email, leaflets, posters, social media and QR codes.
They are designed to reduce stigma around periods, help young people recognise when to seek medical help, and raise awareness of conditions like endometriosis.
They also provide information on pelvic health and menopause to support understanding of health issues throughout their lives.
Members of the Cardiff and Vale University Health Board youth panel who helped create the materials were at the launch event at the Children’s Hospital in Cardiff.
Sarah Murphy, Minister for Mental Health and Wellbeing, said: “These new resources will help to support the health and wellbeing of young people across Wales.
“By working directly with young people to develop these materials, we’ve ensured they address the real questions and concerns they have.
“I’m grateful to all the young people who have contributed their insights and experiences to make these materials relevant and accessible.
“This is part of our commitment to address the gender health gap and improve health outcomes for women and girls across the country.”
Nestlé joins UN-led coalition supporting women’s health
Nestlé has announced it has joined the Coalition for Reproductive Justice in Business, led by the United Nations Population Fund (UNFPA).
The coalition aims to drive private-sector investment into advancing comprehensive health policies and measurable standards for women’s health across workplaces, supply chains, and broader business ecosystems.
“We are proud to join this initiative and collaborate with UNFPA and other coalition members to redefine how businesses address women’s health,” said Serena Aboutboul, global head of nutrition division at Nestlé.
“From maternal health to menopause, our commitment is unwavering.
“We provide innovative and tailored nutrition solutions, ensure respectful workplace conditions, and increase support to women. When women thrive, families, communities, and economies flourish.”
The coalition’s work supports the UN Sustainable Development Goals on Good Health and Wellbeing and Gender Equality.
By becoming a coalition member, Nestlé will help strengthen broader corporate action in line with the UNFPA’s scorecard of metrics and indicators for women’s health and wellbeing in the workplace.
“We welcome companies taking concrete steps to strengthen women’s health and rights in the workplace,” says Mariarosa Cutillo, UNFPA private sector and civil society branch chief.
“By joining the Coalition, Nestlé signals its commitment to advancing measurable standards and supporting a future where women’s health is recognised as central to business success and societal well-being.”
Ki-67, a protein used to measure tumour growth, may also help prevent chromosome errors that drive cancer, a study suggests.
The findings could change how scientists view Ki-67, a marker commonly used in breast cancer and other tumours to assess how quickly cancer cells are growing.
Researchers found the protein may help preserve genome stability by maintaining the structural integrity of centromeres, key parts of chromosomes that help ensure DNA is shared correctly during cell division.
The research was led by professor Paola Vagnarelli at Brunel University of London in collaboration with scientists at the University of Edinburgh and the Technical University of Berlin.
Professor Vagnarelli said: “Doctors already measure Ki-67 to see how aggressive a cancer might be. But our results suggest it is actually helping maintain genome stability.
“That means it may be more than a marker. It could potentially also be a therapeutic target.”
The study examined three proteins that attach to chromosomes during cell division and help rebuild the molecular system that tells each new cell what kind of cell it is.
Every human cell carries identical DNA. What makes a liver cell different from a brain cell is which genes are switched on and which are kept inactive.
When a cell divides, that entire system of switches must be rebuilt. The three proteins involved in this process were Ki-67, Repo-Man and PNUTS.
Vagnarelli’s team developed a method that individually removes each protein from a living cell at the precise point of division. Older techniques could not isolate that moment cleanly.
They found that cells rely on all three proteins to reset themselves after division, but each failed in a different way when removed.
Without PNUTS, gene activity spiralled out of control and thousands of genes switched on at once.
Without Repo-Man, cells escaped safety checkpoints that usually stop damaged or abnormal cells from continuing to divide.
“What we didn’t expect was how clean the separation was,” said Vagnarelli.
Each protein fails in its own specific way. There is no redundancy, no safety net. Which means there are three separate points at which this process can go wrong.
“When the system breaks down, cells can emerge with the wrong number of chromosomes. That condition, called aneuploidy, is seen in disorders such as Down syndrome and in many cancers.
“We also found that these chromosome errors can trigger inflammatory signals inside the cell.”
Aneuploidy means a cell has too many or too few chromosomes, which can disrupt normal growth and function.
Inflammatory signals are chemical messages that can make a cell behave as if it is responding to injury or infection.
“These cells behave almost as if they are under attack,” said Vagnarelli.
“The immune response switches on because the genome is unstable.
“That link between chromosome imbalance and inflammation could help explain patterns we see in several diseases.”
The researchers said the findings may help cancer scientists better understand how chromosome instability, loss of gene regulation and cells dividing before they are ready contribute to tumour growth.
They said understanding the normal machinery that prevents these errors may help researchers find ways to push cancer cells into making mistakes they cannot survive.
“We now have a clearer map of the machinery that resets the cell after division,” said Vagnarelli.
“That knowledge gives us a starting point for thinking about new therapeutic approaches.”
After more than a decade of campaigning, doctors around the world have agreed to rename polycystic ovary syndrome (PCOS).
It is hoped the new name, polyendocrine metabolic ovarian syndrome, or PMOS, will help end the misconception that the condition is all about cysts, which campaigners say has contributed to missed diagnoses and inadequate treatment.
The condition affects one in eight women, or 3.1m women and girls in the UK, and is linked to hormone fluctuations that can affect weight, mental health, skin and the reproductive system.
The renaming was spearheaded by UK patient charity Verity alongside Professor Helena Teede, director of Melbourne’s Monash Centre for Health Research and Implementation.
It followed 14 years of consultation with clinicians and patients around the world.
The new name was published in a consensus statement on May 12 and announced at the European Congress of Endocrinology in Prague.
The paper states that PCOS should now be referred to as PMOS.
“This is a landmark moment that will lead to desperately-needed worldwide advancements in clinical practice and research,” said Professor Teede.
“It was heart-breaking to see the delayed diagnosis, limited awareness and inadequate care afforded those affected by this neglected condition.”
When doctors first named PCOS in 1935, they thought it was mainly caused by physical changes to the ovaries.
Decades of research have since changed that understanding, with clinicians now agreeing the condition is far more complex.
“What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” Professor Teede added.
“A name change was the next critical step towards recognition and improvement in the long term impacts of this condition.”
The exact cause of the condition is still unknown, though it is thought to be linked to abnormal hormone levels and is associated with insulin resistance and raised levels of testosterone and luteinising hormone.
Insulin resistance means the body does not respond properly to insulin, the hormone that helps control blood sugar. Luteinising hormone helps regulate ovulation.
Common symptoms listed by the NHS include irregular periods or no periods at all, difficulty getting pregnant, excessive hair growth, weight gain, thinning hair, oily skin and acne.
Campaigners have acknowledged that the name change could cause temporary confusion.
“Despite decades of tireless advocacy to improve awareness, we recognised that the risk of change would be worth the reward,” said Rachel Morman, chairwoman of Verity.
“This shift will reframe the conversation and demand that it is taken as seriously as the long-term, complex health condition it is.”
It is also unclear if, or when, the NHS will change the language it uses.
An NHS England spokesperson said: “We routinely review and update content on the NHS website to ensure it reflects the latest clinical advice and will carefully consider these recommendations.
“The NHS will also continue our work to improve women’s healthcare, including for this important group, which involves giving women more choice over their care, bringing down waiting times, and delivering more care in communities.”
News
The RESIL-Card tool launches across Europe to strengthen cardiovascular care preparedness against crises
By Women As One
Women As One is proud to have contributed to the development of the RESIL-Card tool as an active Advisory Board member, ensuring that gender equity and the perspectives of women cardiologists were embedded from the outset.
Through strategic input on the project’s design, formal support of its EU4Health funding application, and ongoing participation in advisory activities, Women As One has helped shape both the direction and implementation of this initiative.
By amplifying awareness, facilitating engagement from our global community, and advocating for inclusive representation, we have worked to ensure that RESIL-Card reflects the diverse realities of cardiovascular care and supports more equitable, resilient health systems in times of crisis. Read more about our involvement here.
On the European Day for Prevention of Cardiovascular Risk (March 14), the RESIL-Card consortium proudly announces the official launch of the RESIL-Card tool, a free online resource designed to help hospital cardiovascular professionals and other stakeholders assess and strengthen the resilience of their care pathways — ensuring that lifesaving care remains accessible even during times of crisis.
Available now at https://www.wecareabouthearts.org/resil-card/online-tool/, the RESIL-Card tool offers a structured self-assessment framework for evaluating the preparedness of cardiovascular services and identifying concrete actions to maintain continuity of care when health systems face disruption.
“Cardiovascular care must remain uninterrupted regardless of the challenges health systems face,” said Professor William Wijns, Research Professor in Interventional Cardiology, University of Galway, Ireland, and We CARE – RESIL-Card Coordinator.
“The RESIL-Card tool provides healthcare teams with a practical way to assess preparedness, identify improvement opportunities, and ultimately ensure that patients continue to receive lifesaving care when it matters most.”
Why the RESIL-Card tool was developed
Cardiovascular diseases remain the leading cause of death in Europe, making the continuity and resilience of care pathways a public health priority.
Despite advances in diagnosis and treatment, recent crises – from pandemics to geopolitical instability – have exposed the vulnerability of healthcare systems.
In today’s increasingly uncertain health landscape and global environment, proactive preparedness is no longer optional – it is essential.
The RESIL-Card tool was developed as part of an EU4Health-funded initiative to support organisations providing lifesaving cardiovascular care in strengthening their preparedness, improving coordination, and safeguarding patient outcomes in times of disruption.
The initiative focuses on practical resilience strategies to help health systems anticipate challenges rather than simply react to them.
“Healthcare systems today operate in an increasingly complex and unpredictable environment,” said Ariadna Sanz, Health Policy Manager at the Catalan Health Service (CatSalut).
“Tools like RESIL-Card help shift the focus from responding to crises toward proactively building strong, adaptable cardiovascular care pathways that protect patients over the long term.”
A collaborative and evidence-based methodology
The RESIL-Card tool is grounded in a robust, multidisciplinary development process involving cardiovascular experts, healthcare professionals, public health specialists, patient organisations, and policy stakeholders from across Europe.
Its development combined comprehensive literature reviews and analysis of existing preparedness frameworks with extensive stakeholder consultations and co-creation workshops. Real-world insights from healthcare providers and patient representatives were integrated throughout the process to ensure the tool reflects the practical realities of cardiovascular care delivery. The methodology also included iterative testing and validation phases, allowing the consortium to refine the tool and ensure it is both scientifically rigorous and practical for everyday use.
“From the outset, RESIL-Card was co-created with clinicians, patient representatives, and health system experts to ensure it reflects real-world practice,” said Professor Niek Klazinga, Em. Professor of Social Medicine, Amsterdam University Medical Centre / University of Amsterdam.
“The result is a tool that combines scientific rigour with practical usability, enabling healthcare teams to translate resilience concepts into concrete action.”
What the RESIL-Card tool is and how it works
The RESIL-Card tool is a practical online self-assessment instrument designed for use by a multistakeholder resilience team led by cardiovascular care providers.
Through a structured four-step process, including a questionnaire and guided analysis, users assess the preparedness and resilience of their cardiovascular care pathways and gain a clear understanding of how well their services can maintain care continuity during periods of disruption.
The assessment process helps teams identify existing strengths as well as potential gaps in service delivery.
Based on the responses provided, the tool offers tailored recommendations and examples of best practices to support improvement.
These insights can then inform strategic planning, helping organisations prioritise actions that reinforce care continuity, strengthen patient safety, and optimise the long-term sustainability of cardiovascular services.
Benefits for Key Stakeholders
For healthcare professionals and organisations delivering cardiovascular care, the RESIL-Card tool provides a structured way to strengthen preparedness and crisis-response capacity.
By helping teams assess their existing systems and identify areas for improvement, the tool supports better coordination across services and clinical disciplines.
It also facilitates evidence-based planning and quality improvement initiatives, enabling healthcare organisations to enhance their operational resilience while maintaining efficient and manageable care processes.
“By promoting awareness about strengths and limitations of each system, the RESIL-Card tool will help physicians to understand where improvements are needed and strengthen coordination and planning to face crises,” said Doctor Alfredo Marchese, Chief of Interventional Cardiology Department at Santa Maria Hospital, Bari, Italy and President of the Italian Society of Interventional Cardiology (GISE).
For patients and patient organisations, the RESIL-Card tool contributes to improving the reliability and continuity of essential cardiovascular care.
By encouraging healthcare providers to proactively address vulnerabilities in care pathways, the tool helps promote uninterrupted access to diagnosis, treatment, and follow-up services.
It also supports a more patient-centred and equitable approach to care delivery, encouraging collaboration and transparency in preparedness planning.
Ultimately, these improvements can contribute to better health outcomes and increased safety for people living with cardiovascular disease.
“For people living with cardiovascular disease, continuity of care is not optional — it is essential,” said Teresa Glynn, Senior Executive Strategy & Partnerships at Global Heart Hub.
“By helping healthcare providers strengthen preparedness, RESIL-Card supports more reliable and equitable access to treatment and greater confidence for patients and their families.”
At the European level, the RESIL-Card initiative contributes to a shared effort to strengthen the resilience of health systems.
By providing a common framework for assessing and improving preparedness, the tool encourages cross-border learning and facilitates the exchange of best practices among healthcare providers and policymakers.
It also aligns closely with European Union priorities on health system preparedness, crisis response, and sustainability.
By helping healthcare organisations identify vulnerabilities and implement practical resilience measures, the RESIL-Card tool can support efforts to reduce inequalities in access to high-quality cardiovascular care across EU Member States.
“Strengthening the resilience of cardiovascular care is a shared European priority,” said Rachel Kenna, Ireland’s Chief Nursing Officer at the Department of Health.
“While the RESIL-Card tool has not yet been tested in an Irish setting we look forward to seeing how it can support the development of more sustainable and prepared healthcare systems.”
Call to Action
Cardiovascular care providers and other healthcare professionals are encouraged to explore the RESIL-Card tool at https://www.wecareabouthearts.org/resil-card/online-tool/.
By using it to assess their cardiovascular care pathways, they will identify areas where resilience can be strengthened and ensure that essential services remain accessible during times of disruption.
Patient organisations also play an important role in this effort. By engaging with healthcare providers and policymakers, they can help promote the use of the tool and ensure that patient perspectives are meaningfully incorporated into preparedness and response planning.
Policymakers and health authorities are invited to support the adoption of the RESIL-Card tool within regional, national and European strategies aimed at strengthening healthcare system resilience.
Integrating the tool into policy frameworks can help safeguard access to essential cardiovascular services and enhance the ability of health systems to respond effectively to future challenges.
Learn more about Women As One at womenasone.org
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