Proving the Business Case for the Internet of Things

Sensor and app help predict ovulation

Steve Rogerson
August 9, 2016

An internal sensor combined with a mobile phone app is claimed to provide a 96 per cent accurate prediction of the start of ovulation.
Developed by UK company Fertility Focus, which has just completed a funding round to allow the product launch, OvuSense provides 24 hours' advance notice of ovulation, with clinically proven 96 per cent correct results, and 99 per cent accurate detection of the exact date of ovulation. At the start of each cycle, it provides a full eight-day fertile window to help in planning for pregnancy.
"In a crowded market for fertility trackers, we set out to make OvuSense completely different,” said Rob Milnes, CEO of Fertility Focus. “This is a Class 2 registered medical device backed by an extensive portfolio of patents and clinical trials."
Clinically proven in more than 6000 cycles, the OvuSense sensor is worn in the vagina overnight to measure core body temperature. In the morning, the user downloads the data to the OvuSense app, which analyses and produces a daily fertility graph.
Core body temperature has been proven in clinical trials to be more accurate than monitoring with urine, external temperature and fertility tracker apps, which can produce an incorrect result one in every five cycles.
Courtney, an OvuSense app study user, said: "I have been trying to conceive for five years. My doctor said I didn't ovulate for the month of May, but OvuSense said I did. My husband and I had sex around the time OvuSense said and I woke up to a positive pregnancy test."
And fertility nurse Kate Davies added: "The key to OvuSense is that it monitors core temperature, providing a direct indication of the progesterone released during ovulation, but also allowing monitoring of levels in the rest of the cycle. That's helpful for all women, especially the 70 per cent of women trying to conceive for more than six months who suffer with ovulatory issues."
The iOS version of the app launched last month in the UK and USA and the Android version is due this month.
OvuSense is a regulated medical device and carries the CE mark in Europe, FDA 510(k) in the USA, CMDCAS in Canada and TGA in Australia.
Women with any degree of cycle irregularity either in cycle length or ovulation timing can struggle with detection methods such as basal body temperature and blood serum testing, because the irregularity makes these methods unreliable tools for prediction of ovulation.
OvuSense was developed to provide the same benefit as LH (luteinising hormone) tests by predicting the onset of ovulation up to one day in advance in real time in each cycle. However, unlike ovulation predictor kits, OvuSense provides a clinically accurate detection of the exact date of ovulation, and can help diagnose any ovulatory conditions by showing an accurate picture of progesterone levels throughout the cycle.
As OvuSense takes temperature measurements in the vagina, it is not prone to the external influences that make traditional oral or skin measurement unreliable. Taking readings every five minutes each night means it can create an accurate set of values over a short period of time. By averaging out these data, it can look up the temperature curve as soon as it finds the lowest point, and by reference to the trial and field database assembled on OvuSense, the date of ovulation can be known in advance in real time.
Also, LH is only predictive of the onset of ovulation and cannot determine the date of ovulation or anovulation. Urinary LH measurement is therefore of little practical use for women who experience ovulatory disorders.