This afternoon London-based Concepta Diagnostics unveiled exclusively to MobiHealthNews the UK release of its myLotus Fertility app and monitoring system, which lets women trying to conceive test their hormone levels at home.
The new product and app uses luteinising hormone (LH) levels — higher levels indicate ovulation — to help predict when a woman has the best chance to become pregnant.
The way it works is a user enters each new cycle into the app starting with the first day of their period and records bleeding days. On the eighth day of a woman’s cycle the monitor will request an LH test. Women test themselves on the monitoring system and then enter the results into the app.
The user does this every day until there is a "surge” in LH. After the first cycle the system will be able to “personalize the user's hormone profile and calculate testing days for ovulation.” The app will help women keep track of their most fertile days.
The system is also designed to help women detect if they are pregnant through LH levels.
Concepta’s chairman, Matthew Walls, said the system is different than others on the market because of its ability to test LH levels.
“myLotus is the only fertility monitor providing women with a quantitative measurement of how much of their [LH] is present in their urine and the rate-of-change in this measure, which can also be tracked and viewed in the free accompanying myLotus app,” Walls wrote in an email to MobiHealthNews. “Other digital fertility monitors also measure fertility hormones, but only provide qualitative results in symbols based on a set threshold that is based on the average woman. If a woman´s LH levels are above or below the normal range, they will not be able to identify their LH surge with these qualitative tests as they would get false negative or false positive results. Digital monitors based on temperature rely on building up a picture of your temperature charts in order to predict ovulation in future cycles. It confirms ovulation after the event.”
The system has been in the works for some time. Prototypes of the system were first launched in 2016 and validated in 2017. The final user testing went through the regulatory process in 2018.
As for future plans the company will continue working on this platform and adding other tests.
“We are also developing further tests for our myLotus device around progesterone, estrogen and FSH which will provide a more comprehensive assessment of a women’s menstrual cycle and fertility,” Walls wrote.
Why it matters
Fertility rates in many part of the world including the US, UK and Japan have continued to drop since the 1960s, according to the World Bank. For example, in 1960 American women had an average of 3.7 babies — that number has dropped to 1.8 in 2016.
A conflux of factors including women waiting to have children and having less children are responsible. Fertility rates decline in women in their 30s, particularly after age 35, according to the American Society of Reproductive Medicine.
Concepta is pitching this as an avenue for women to figure out the best time to get pregnant.
“myLotus will allow a women to accelerate her chances of naturally getting pregnant by identifying their optimal time to conceive based on their ovulation pattern or individual ‘signature,'" Walls said. "Women are encouraged to identify their personal cycle patterns by using myLotus over a couple of cycles to identify their cycle variability and hormone levels along with a more accurate assessment of when they ovulate and therefore when to have sex to naturally conceive. Ovulation is preceded by the body’s natural surge in luteinising hormone levels.”
What's the trend
Fertility apps and systems are a popular topic in digital health. Mira has also launched an at-home fertility testing system, which has FDA and CE Mark clearances. Ava is another company working on helping women understand their reproductive health. That system offers a fertility tracker and access to one-on-one fertility testing.