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Fertility

Why hormone testing shouldn’t be a one-off

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Progesterone is a key hormone in assessing ovulation. FemTech World speaks to Amy Beckley, founder of Proov, to find out how at-home testing could change the way infertility is diagnosed and treated.

Progesterone is a female sex hormone produced mainly in the ovaries following ovulation each month – a crucial part of the menstrual cycle and maintenance of pregnancy.

But when progesterone levels are low, women may have difficulty conceiving and experience uterine bleeding, irregular periods and spotting.

In the US, over six million women – 10 per cent of the female population – aged 15-44 have difficulty getting pregnant or staying pregnant.

“This happens because the US healthcare system is very reactive,” says Amy Beckley, scientist and founder of the home testing company Proov.

After seven miscarriages Beckley and her husband had to actively try conceiving for 12 months before they could see a fertility expert. She was diagnosed with unexplained infertility and the doctors recommended IVF.

“I have a PhD in pharmacology, so I’ve been studying hormone signalling for a long time,” she explains.

“I realised the only thing that was different between my IVF cycles and my natural pregnancies was the fact that after embryo transfer I was put on progesterone supplements to support my luteal phase. This actually matched my previous idea, that I must have a progesterone deficiency causing my short luteal phases.

“But since progesterone in blood fluctuates a lot, one single blood test can’t detect suboptimal levels throughout the implantation window. The research [on progesterone] was there, but nobody had actually come up with a diagnostic test.”

This is when Beckley decided to create Proov Confirm, a urine marker of progesterone and the first and only FDA-cleared PdG test kit to confirm successful ovulation at home.

Her company now offers a suite of diagnostics to provide fertility insights throughout the entire menstrual cycle by allowing women to measure all of the menstrual hormones daily.

Women can then snap a photo of each test within the Insight app and follow the in-app prompts to understand ovulation status, get daily insights and an ovulation insights score, along with a personalised action plan to maximise their wellness.

The idea behind Proov was to empower women with critical information about their ovulation and menstrual cycle, the founder says. “Most women don’t check their hormonal health because there’s no help available,” she adds.

“Women are very savvy and very data-driven. When they have a problem, they try to reach out and get help, but very often there’s nobody on the other end to help them.”

“But it’s very important to look at what your hormones are doing over time. Blood testing misses a lot of issues, so by simply giving women that insight and the actual hormone value we want to help them learn about their cycle and understand it.

“We do everything through our free app and women love this digital approach,” Beckley continues. “They love the idea of seeing numbers and having all the data they need. They love having it stored and having a notification to remind them to take a test the next day.

“It makes things a little bit easier and provides data in a format that’s easily digestible.”

While Proov is already working with a number of American clinics, Beckley hopes to expand their partnerships beyond the US and get approvals in other countries.

“Apart from expanding geographically, we also want to expand into hormonal health in general,” she adds.

“We’re really good at understanding the menstrual cycle to help women get pregnant and we realised that the menstrual cycle is not only important for getting women pregnant, but it’s also important for everyday life.

“Our goal is to support women through heavy, painful periods, PMS and menopause and help them thrive during those hard times.”

Tests are available on proovtest.com and amazon.com.

 

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Merck partners on intravaginal drug delivery device

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Calla Lily Clinical Care has partnered with Merck to support the intravaginal drug delivery platform Callavid in an effort to improve how vaginal medicines are given.

The collaboration will continue development of Callavid, described as a leak-resistant device that addresses challenges with self-administered vaginal therapies.

Callavid uses a small, tampon-shaped device with an integrated absorbent liner. It is inserted, remains in place during drug absorption, then is removed.

The platform is intended for use with medicines in fertility treatment, oncology and hormone therapy. Administration via the vaginal route can prompt patient anxiety about positioning, dosing accuracy and leakage.

The partnership is the first industry collaboration for the Callavid technology, which was developed by Calla Lily Clinical Care.

Thang Vo-Ta, co-founder and chief executive of Calla Lily Clinical Care, said: “This collaboration with Merck marks an important milestone in the development of Callavid, our novel vaginal drug delivery platform.

“Merck’s scientific heritage and forward-looking approach to innovation make them an ideal partner as we work to address long-standing unmet needs in women’s health.

“By improving how vaginal therapeutics are delivered and experienced, Callavid has the potential to enhance both patient outcomes and quality of life.

“We see this collaboration as a meaningful step towards translating our technology into real-world clinical and patient impact.”

Calla Lily Clinical Care is seeking to develop what it describes as the world’s first drug-device combination product to prevent threatened miscarriage and for IVF luteal phase support, the phase after ovulation when the body produces progesterone to support early pregnancy.

The device is also being developed to deliver therapeutics for oncology, menopause, infectious diseases and live biotherapeutics to reduce repeated antibiotic use.

Dr Lara Zibners, co-founder and chairman of Calla Lily Clinical Care, said: “Our initial engagement with Merck through the Merck Innovation Challenge in October 2024 was an important moment of alignment around the need for more patient-centric innovation in women’s health.

“As both a clinician and a patient, I have seen how profoundly drug delivery can shape treatment experience.

“This collaboration builds on that early dialogue and reflects a shared interest in rigorously exploring new approaches that may improve how therapies are delivered and experienced by patients.”

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France urges 29-year-olds to start families now

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France is urging 29-year-olds to have children as part of a 16-point plan to boost fertility and raise birth rates.

Health officials say the aim is to prevent men and women facing fertility problems later in life and thinking “if only I had known”.

The strategy comes as the country, like many western nations including the UK, faces tumbling birth rates.

The trend is creating concerns about how governments can fund pensions and healthcare for ageing populations with fewer younger working people paying taxes.

But policies to raise fertility rates globally have produced limited results, and critics of the scheme suggest better housing and maternity provision could be more effective.

The government will send out “targeted, balanced, and scientifically sound information” to young people on issues including sexual health and contraception.

The material “will also reiterate that fertility is a shared responsibility between women and men,” the country’s health ministry said.

The plan includes efforts to increase the number of egg-freezing centres from 40 to 70. The process involves extracting and storing a woman’s eggs for potential future use.

The country’s health system already provides free egg-freezing for people aged 29 to 37, a service that costs about £5,000 per round in the UK.

The country’s fertility rate of 1.56 children per woman is below the 2.1 needed to maintain a stable population.

However, it is higher than rates in China, Japan and South Korea, and the UK, where the latest figures show it dropped to a record low of 1.41 in England and Wales by 2024.

Professor François Gemenne, who specialises in sustainability and migration at HEC Paris Business School, told Sky News: “This is something that demographers had known for a long time, but the fact that there were more deaths than births in France last year created a shock effect.”

He said the country’s “demographic worry” is exacerbated by the design of its pensions system and its “obsession with immigration and the fear of being ‘replaced'”.

The plan also includes a new national communication campaign, a “My Fertility” website advising on the effects of smoking, weight and lifestyle, and school lessons for children about reproductive health.

The health ministry has acknowledged its maternal and infant mortality rates are higher than neighbouring countries and is beginning a review of perinatal care to address the “concerning” situation.

Channa Jayasena, professor in reproductive endocrinology at Imperial College London, told Sky News: “On the female side, societal changes leading to older age of motherhood are certainly important.

He said obesity was also a problem as it increased women’s risk of polycystic ovary syndrome and endometriosis.

Allan Pacey, professor of andrology (male reproductive health) at Manchester University, said for most people globally, deciding to have children was “down to [non-medical] factors such as better access to education, career opportunities, taxation, housing, mortgages, finance, etc.”

“Medicine can’t help with those things,” Pacey added.

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Covid vaccine not linked to decrease in childbirth, study finds

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The Covid vaccine is not behind a fall in childbirth, a Swedish study has shown.

Rumours on social media have alleged that the jab impairs chances of becoming pregnant.

In the later stages of the pandemic, some countries, including Sweden, saw fewer births, raising the question of whether vaccines were responsible.

The study analysed all women aged 18 to 45 years in Region Jönköping County, Sweden, a total of almost 60,000 women. Of these, 75 per cent were vaccinated once or more against Covid-19 from 2021 to 2024.

Researchers at Linköping University used healthcare records on childbirths, miscarriages and deaths.

Comparing vaccinated and unvaccinated groups, the researchers found no statistically significant differences in childbirths or miscarriages.

This aligns with previous studies finding no link between the Covid vaccine and fertility.

 Toomas Timpka is professor of social medicine at Linköping University.

Timpka said: “We see no difference in childbirth rates between those who have taken the vaccine and those who haven’t.

“We’ve also looked at all registered miscarriages among those who became pregnant, and we see no difference between the groups there either.

“Our conclusion is that it’s highly unlikely that the mRNA vaccine against COVID-19 was behind the decrease in childbirth during the pandemic.”

The researchers suggest other explanations for the dip in births.

People now in their 30s were born in the late 1990s, a period of economic strain and lower birth rates in Sweden, shrinking today’s cohort of potential parents.

Additional pandemic-related factors, such as health and economic concerns and changed behaviour during lockdown, may also have reduced childbirth.

A strength of the study is its large, nationally representative cohort.

The analysis adjusted for age to avoid masking any potential vaccine effect on childbirth.

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