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First patients dosed in miscarriage trial

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The first patients have been dosed in a UK miscarriage trial testing a new intravaginal drug delivery platform for threatened miscarriage.

The FREEDOM study is evaluating 400mg progesterone Callavid in patients diagnosed with luteal phase insufficiency, a condition in which progesterone levels may be too low to support early pregnancy, increasing the risk of infertility and recurrent miscarriage.

Callavid uses a patented leak-free, tampon-like design intended to address the limitations of current vaginal treatments, which rely on self-administered pessaries, or vaginal suppositories, that can leak and may move during use.

The device is being developed by London-based Calla Lily Clinical Care, a medical technology company focused on women’s health. The trial is funded by the National Institute for Health and Care Research and run in collaboration with the Trial Management Unit at University Hospitals Coventry and Warwickshire NHS Trust.

According to the company, Callavid is positioned to become the world’s first drug-device combination product to support treatment of threatened miscarriage, as well as luteal phase support as part of assisted reproductive technologies, including in vitro fertilisation, or IVF.

The Government’s Renewed Women’s Health Strategy for England cites estimates ranging from 120,000 to 250,000 cases of miscarriage a year in the UK. Administering 400mg micronised progesterone twice daily is recommended by the National Institute for Health and Care Excellence for women who have suffered a previous miscarriage and experience bleeding during early pregnancy, known clinically as threatened miscarriage.

Current pessary delivery methods can result in uncertain placement and movement during use. These limitations can reduce the efficiency and consistency of drug absorption, potentially compromising delivery of the intended dose, and patients are regularly advised to lie horizontal for extended periods after each administration.

The FREEDOM trial is led by professor Siobhan Quenby MBE, an authority on miscarriage and preterm birth, and an honorary consultant at University Hospitals Coventry and Warwickshire NHS Trust. The study aims to evaluate safety, user acceptability and progesterone absorption, with the goal of providing evidence of improved usability in self-administration.

Quenby commented: “Through my clinical practice, I see the difficulties patients face with existing vaginal progesterone products at an already very stressful time. Callavid offers a promising new solution to ensure delivery of the correct progesterone dosage and give women greater confidence in their treatment. There is genuine excitement among both clinicians and patients at the prospect of Callavid progressing into clinical trials.”

Dr Lara Zibners, co-founder and chair of Calla Lily Clinical Care, added: “As a physician and entrepreneur, I believe we have a responsibility to create more effective, patient-centred solutions in women’s health. Having been through seven rounds of IVF myself, I have experienced how difficult progesterone treatment can be, and I am proud to be advancing an innovation shaped by both medical insight and lived experience.”

Thang Vo-Ta, co-founder and chief executive of Calla Lily Clinical Care, said: “Dosing the first patients in the FREEDOM study marks a critical milestone for Calla Lily Clinical Care. Callavid represents a differentiated delivery modality for a broad range of therapeutics in the pharma pipeline, and will create new opportunities to extend the lifecycle of existing drugs. This trial is a key step in demonstrating Callavid’s massive potential.”

Menopause

Xella Health announces Oura data integration

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Xella Health has integrated Oura wearable data into its women’s health platform, allowing members to share trends with clinicians alongside diagnostic results.

Members can choose to share information including sleep, heart rate variability, resting heart rate, temperature trends, recovery, activity and menstrual-cycle data.

The integration is intended to help clinicians investigate biological factors that may explain changes in members’ wearable data and symptoms.

Kelly Lacob, chief executive and co-founder of Xella Health, said: “Wearables detect that something in the body has changed, but wearable data alone can’t tell a woman why or what to do next with that information.”

“By pairing continuous physiological monitoring from Oura with Xella’s multiomic diagnostics and physician-guided care, we enable women to understand how specific health concerns are impacting her biometrics, and vice versa how her daily habits are impacting her overall health and specific conditions or life stages she is navigating.

“Further, we are able to track how her relevant vitals and biometrics respond to specific interventions or treatment plans, so we can optimise her care more efficiently.

“Ultimately, this partnership helps us better address her symptoms today whilst also proactively optimising her long-term health trajectory for decades to come.”

Xella Health combines AI, multiomic testing and physician-guided telehealth care through a membership platform.

Multiomic testing analyses several types of biological information.

Xella said its testing assesses hormonal and metabolic health, inflammation, nutritional status, reproductive health and cardiometabolic risk.

Physicians use those findings to develop personalised care plans that may include clinical treatments.

Clinicians can then review shared Oura trends alongside diagnostic results and member check-ins to monitor progress and adjust care over time.

The company said providers interpret biometric data in the context of each member’s health conditions, goals and treatment plan.

The integration focuses on fertility, perimenopause, hormonal and cardiometabolic health, as well as women’s longer-term health.

Oura has expanded its women’s health offerings through integrations connecting wearable measurements with other sources of health data.

In February, it partnered with at-home hormone tracking company Mira, allowing users to view hormone test results alongside sleep, temperature and readiness data in the Mira app.

The integration is intended to help users track patterns related to fertility, menstrual cycles and perimenopause.

That month, Oura also introduced a women’s health AI model for testing through Oura Labs.

Integrated into Oura Advisor, the model combines biometric data with clinician-reviewed medical information to provide guidance on menstrual cycles, pregnancy and menopause.

In May, the company launched menopause insights and hormonal birth control support.

Its Menopause Insights offering uses a questionnaire covering 22 symptoms of menopause alongside wearable data, while birth control support helps users understand their biometric trends in the context of hormonal contraception.

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Insight

Trust apologises for ‘human error’ after maternity data loss

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Nottingham University Hospitals NHS Trust has apologised after a human error caused 11 years of maternity data to be overwritten.

The incident happened during routine technical work on 18 August, when computer instructions intended to create a copy of a radiotherapy database were mistakenly applied to the maternity database.

Most of the affected information has since been recovered, including notes, observations, test results and other information recorded as part of patient care.

However, the trust has been unable to fully restore the historical record showing who viewed maternity records between September 2011 and November 2022.

Current data was not affected and the incident has had no impact on current maternity services or care provided to women and babies, according to the trust.

It also said no information was accessed or used inappropriately as a result of the incident.

Andy Callow, chief digital and information officer at Nottingham University Hospitals, said: “I am sorry for the concern and distress this incident may cause to women and families affected.

“On 18 August 2026, a human error during a routine technical process resulted in a maternity records database being unintentionally overwritten.

“We took immediate action to investigate the incident and recover the affected information.

“The information needed to support patient care has been restored and there has been no impact on current maternity services or the care provided to women and babies today.

“However, to date, we have been unable to fully restore the historical record showing who viewed maternity records between September 2011 and November 2022.

“We have informed the Information Commissioner’s Office, completed a full investigation and strengthened our processes and controls to help prevent a similar incident from happening again.”

The error occurred when pre-written computer instructions previously used for another hospital system were used during the technical work.

A setting that should have been changed was not altered, resulting in work being carried out on the maternity database instead of the radiotherapy database.

The issue was escalated within minutes of being identified and experts were brought in to recover as much information as possible.

The trust has referred the incident to the Information Commissioner’s Office and notified Nottinghamshire Police, which is conducting a separate criminal investigation into maternity care at the trust.

The force is assessing whether the loss of information about who accessed maternity records could affect that investigation.

The incident follows a maternity review led by midwife Donna Ockenden, which concluded in June after examining the cases of 2,500 families over a 20-year period.

The review found more than 500 mothers and babies suffered potentially avoidable harm, with 162 dying following substandard care. Some babies who survived were left seriously disabled.

Nottinghamshire Police announced its separate criminal investigation, Operation Perth, in September 2023.

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UK reviews surrogacy firm over rejected insurance claims

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The UK government is reviewing a surrogacy firm after complaints that medical insurance claims involving surrogates in Mexico were rejected.

The Department of Health and Social Care (DHSC) is considering whether UK-based provider My Surrogacy Journey should remain listed on gov.uk as one of four domestic surrogacy agencies available to intended parents.

The review follows allegations concerning its Mexican sister company, where surrogates are based.

Health minister Diana Johnson said: “The department is looking into the allegations about My Surrogacy Journey.

“As part of that assessment, the department will consider whether it is appropriate for that company to remain on the gov.uk list of agencies.”

Emails sent by My Surrogacy Journey chief executive Michael Johnson-Ellis and seen by the Guardian suggest multiple surrogate women in Mexico had their insurance claims rejected.

The emails also suggest 300 couples using the company were moved to a new insurance provider because of the increased risk of claims being rejected.

Commercial surrogacy is banned in the UK, where only altruistic arrangements are permitted.

My Surrogacy Journey operates a not-for-profit UK branch alongside for-profit sister companies in Mexico and the US. All three companies have the same owners and chief executives.

The reported insurance issues relate to surrogacy arrangements in Mexico.

One couple told the Guardian they paid tens of thousands of pounds to cover medical costs after their surrogate had a hysterectomy during childbirth and an insurance claim was refused.

The Guardian said it understood that at least five sets of parents said they had to cover medical costs after insurance claims were rejected.

In an email to the couple whose surrogate underwent a hysterectomy, Johnson-Ellis wrote: “We have already told you that the insurance companies have been declining some of the claims and we are actively working with the broker to get this issue resolved but you should also consider that they may not be paid out and there is nothing we are able to do to change this …

“We appreciate this is not an insignificant sum but this genuinely is out of our control.”

Johnson-Ellis also said the company had switched insurance providers, writing: “We’re also managing this for 300 other journeys, which is a complex position to be in.”

Lawyers acting for My Surrogacy Journey said the company did not comment on individual cases, but that existing insurance policies were in place and claims continued to be accepted and processed.

They said the company understood that a small number of claims had been rejected and was supporting people seeking to resolve those claims with an insurer.

Under the surrogacy arrangements, intended parents are understood to be contractually required to cover medical costs not paid by an insurer.

The couple said they had been recommended the company’s Mexico option. Its website advertises that intended parents using the route can have a baby in “under 18 months”.

They said they were told the UK route could take up to five years and that the US option was much more expensive.

Lawyers for My Surrogacy Journey said prospective parents are given information about typical timelines, costs, legal frameworks and practical considerations, and that the 18-month timeframe is indicative only.

The couple said their surrogate developed placenta accreta, a serious condition in which the placenta attaches to the wall of the uterus.

Emails from Johnson-Ellis acknowledged that the insurance provider investigated the birth after the surrogate experienced health complications.

The parents are considering legal action, while the Guardian said it understood at least four other couples were reviewing their options.

Phil Brickell, MP for Bolton West, raised concerns in parliament about a separate couple who had used My Surrogacy Journey.

He said: “Two of my constituents recently travelled to Mexico, where their children were born by surrogacy.

“Those births were facilitated by a company called My Surrogacy Journey, which is listed on gov.uk.

“While in Mexico, they had repeated traumatic experiences with the company relating to issues including insurance for their children, accusations of bullying towards staff and repeated efforts to silence any constructive criticism.

“I understand that other members of this house have received similar complaints.”

Brickell called for My Surrogacy Journey to be removed from gov.uk pending a review by the Human Fertilisation and Embryology Authority.

Lawyers acting for My Surrogacy Journey said the company was communicating with DHSC and was confident any issues could be resolved.

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