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Thursday 13 January 2022

Tiny implantable device trialled to detect fertility problems

A world-first clinical study in Southampton is implanting a tiny sensor inside the womb to unlock answers to fertility problems.

The wireless device, which is the size of a 5p coin, monitors several key factors for fertility over a seven-day period. The new insight could help women experiencing infertility or recurring miscarriages to find quicker and more tailored care.

Volunteers aged between 18 and 42 are being invited to enter the study at the Princess Anne Hospital in Southampton.

Diagnosing causes of unexplained fertility

Around one in seven UK couples experience problems when trying to conceive. Doctors are unable to determine the cause of fertility problems in up to a quarter of cases.

Infertility can be caused by many factors, including oxygen, pH and temperature levels inside the womb. The new uterine sensing device enables scientists to measure these three levels across several days for the first time.

The technology was invented by the University of Southampton’s Professor Ying Cheong and Professor Hywel Morgan. It is now being developed by Verso Biosense, an Oxford-based women’s health company.

Professor Cheong explains: “There has been, to date, no reliable way to understand how the womb environment affects fertility. With this device we have, for the first time, the ability to understand precisely what is happening in the womb with the possibility of taking swift and simple interventions as a result that could drastically change the fertility outlook.

“Our aim - and our belief - is that we can get to a point with the technology that it can be seen as no different to taking a patient’s blood pressure, giving us a great insight into potential problems earlier and in a less invasive way.

“The result could be huge in that if we know, for example, a drop in pH levels could be related to bacteria in the gut then a person may benefit from probiotics, while poor oxygen levels could be altered by aspirin to increase blood flow.”

Women needed for world-first trial

The sensor device is the same shape and size as the contraceptive coil, although it is not a contraceptive. It is inserted into the womb in a clinic and remains in place for seven days.

During the study, the device sends data wirelessly twice an hour to a receiver held on bespoke underwear. Fertility experts would then be able to consider the readings and whether any issues require medical care.

The first volunteers have taken part in the £850,000 clinical trial, which is funded by the National Institute for Health Research.

A further dozen women are invited to take part in the study. They do not need to have a history of infertility or miscarriages. Payment of £100 will be provided for time and inconvenience per visit. The study typically requires three visits to the Princess Anne Hospital.

Prof Cheong added: “If we can prove this device works successfully and is comfortable and safe, then we have the chance to make big changes to fertility care across the NHS and internationally and help to give many more women the best chance of conceiving.

“So far the device has been well received by patients, data has recorded successfully and there was low discomfort, so overall very encouraging and we are moving closer towards being able to improve fertility care quite considerably.”

Anyone interested in participating in the project should call 02381 206 856 or email yc4w07@soton.ac.uk.