USENSE

• Research type

  Research Study

• Full title

  I​ntra­Uterine SENSing using a batteryless, wireless intrauterine platform (U­SENSE)

• IRAS ID

  263353

• Contact name

  Ying Cheong

• Contact email

  y.cheong@soton.ac.uk

• Sponsor organisation

  University of Southampton

• ISRCTN Number

  ISRCTN10654279

• Duration of Study in the UK

  0 years, 3 months, 2 days

• Research summary

  The IRIS Uterine Monitoring Device (IUMD) system developed by researchers from the University of Southampton and Vivoplex Medical Limited, is a novel system that has the potential to monitor three parameters; dissolved oxygen, temperature and pH level within the uterus (womb). These factors are important in embryo development and are tightly regulated within the incubators used in the laboratories carrying out in vitro fertilisation (IVF treatment) but has not been monitored inside the uterus before. The IUMD is designed to look like an intrauterine contraceptive device, for trained health care professionals to place into the uterus. It has an accompanying garment which the patient can wear as pants, and a detachable rechargeable reader, which together provide the means of powering the IUMD, communicating signals and retaining data. This is a feasibility study funded by the National Institute of Health and Research (NIHR) Innovation for Invention program (i4i), and the objectives are 1) to determine the clinical, safety and technical feasibility of conducting a clinical study using the device for real-time in- utero monitoring and 2) to explore the data captured, via the device, of DO, pH and temperature within the uterus of women for up to 7 days. The researchers will aim to recruit 25 women from fertility and gynaecology clinics who can consent, between 18 and 42 with no known chronic illnesses, and are willing to participate in the study. The device will be placed within the womb in an outpatient clinic in a sterile environment for up to 7 days. During this period, there will be a nurse telephone follow up every other day, and also 3 days post removal. The trial will be monitored by a trial management, steering and data monitoring committees, who will report to MHRA, the sponsor and the manufacturer accordingly.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  20/SC/0056

• Date of REC Opinion

  2 Apr 2020

• REC opinion

  Further Information Favourable Opinion