Tiny sensor inside womb taking next steps to ‘revolutionise fertility care’
Researchers have completed the first clinical study of a tiny implantable device that can help detect fertility problems.
The Verso Biosense product monitored 15 women over a seven-day period in the trial at Southampton’s Princess Anne Hospital.
The wireless sensor provided new insight into the womb environment that has never been continuously monitored before.
The data could better inform healthcare professionals when treating female infertility.
Verso Biosense is working towards regulatory approval for the product, which expected before the end of the year
Factors for infertility
One in seven heterosexual couples in the UK are affected by infertility. Only a quarter of the 69,000 IVF cycles performed in the UK in 2019 were successful.
With the exception of temperature, clinicians only have tools that provide single point measures of what is a complex, individual and dynamic uterine environment.
The product can monitor three influential parameters in this environment - oxygen level, temperature and pH.
These parameters are deemed crucial in embryo development and are tightly controlled within the incubators used in in IVF laboratories.
‘Extremely encouraging’
The new sensor device is the same shape and size as the contraceptive coil, although it is not a contraceptive.
The clinical trial was the culmination of a £5 million product development programme at Verso Biosense to which the National Institute for Health and Care Research contributed £850,000 in grant funding.
Professor Ying Cheong, Professor of Reproductive Medicine at the University of Southampton, said:
“The results were extremely encouraging. The device has been well received by patients and data has recorded successfully. Overall, we are very encouraged and are moving towards being able to improve fertility care considerably.
“This wireless implant could revolutionise fertility care and improve the chance of conceiving for many women.”
Seeking regulatory approval
Verso has made an application for regulatory approval for the product with BSI for a UKCA mark and ISO13405 certification. This will shortly be followed by an application for a European CE mark.
The company will now be looking to enter into formal commercial agreements with fertility clinics and clinicians within the UK and Europe to begin commercialisation.
Joseph Cefai, Head of Product Development at Verso Biosense, said:
“Fertility treatment has improved over the last decade as our ability to generate healthy viable embryos for implantation has improved. But problems persist for some women, specifically above the age of 35, in achieving a healthy pregnancy.
“The uterine environment is still considered to be poorly understood and the incidence of unexplained infertility and recurrent implantation failure remains stubbornly high. Our product is aimed at providing a tool set that clinicians can use to better understand the unique, ever-changing and very individual environment into which these precious embryos are being returned.”
Image: Professor Ying Cheong led the trial at the Princess Anne Hospital.