Wikipedia:OvuSense

OvuSense

OvuSense Fertility and Ovulation Monitor is a class II Medical Device for Menstrual Cycle Monitoring developed by viO HealthTech based on intellectual property from the University of Bristol in the UK.

Application

The intellectual property for OvuSense was developed by Dr. Andy Butterworth and Professor Toby Knowles at the University of Bristol. OvuSense measures core body temperature in its original form via a sensor worn in the vagina overnight. In the morning, the user downloads data from the sensor to the OvuSense app which then analyzes and produces an accurate daily fertility graph.

OvuSense measures core body temperature with the aim of providing a more accurate picture of the rise and fall of progesterone than is available by measuring oral or external body temperature. . The ability of core temperature, as opposed to oral or external temperature, to more accurately track the level of progesterone and to provide real time prediction is suggested by Coyne et al.(2000) . Baker FC, Siboza F (2020) provides a useful update to the conceptual understanding of core body temperature stating “Surrogate measures of core body temperature that agree relatively well with blood temperature include esophageal temperature, rectal temperature, vaginal temperature, and gastrointestinal temperature”

Since 2021, a skin-worn sensor has also been available for use with the OvuSense app.. The OvuSense device also includes medication or supplement tracking to see how they effect cycle patterns as well as a feature to determine opportunities of increased fertility.

Clinical trials

Several clinical trials have been conducted to test the accuracy and effectiveness of OvuSense. In September 2012 a clinical trial was conducted to assess the vaginal temperature in comparison to an oral temperature measurement. The clinical trial showed that the OvuSense was more reliable than the oral temperature measurement. A multi-centre international epidemiological study was started in March 2016 with study sites at the University of Bristol in the UK, and Wake Forest University, in the USA: This study initially published results to determine the atypical core body temperature patterns and implications for conditions related to pregnancy, infertility and miscarriage risk. The study concluded that the atypical core body temperature patterns may aid diagnosis especially in elevated risk of miscarriage and pregnancy issues. A further publication determined the atypical vaginal temperature patterns and how it can show subtle, but not yet recognized, causes of infertility. Further data from the clinical study was published to see how the atypical temperature patterns can aid to identify infertility issues and miscarriage risks. The study concluded that the atypical core body temperature patterns can aid in a diagnosis especially in an elevated risk of miscarriage.. Since 2021, a skin-worn sensor has also been available for use with the OvuSense app and a side-by-side study with the vaginal sensor was published in 2022 showing a novel technique for the confirmation of day of ovulation and prediction of ovulation in subsequent cycles.