Ian Bolland spoke to Dr Elina Berglund, CTO and co-founder of Natural Cycles about the journey the digital contraceptive has gone on; from the initial idea to being approved in America and Europe, the thinking around contraception and securing users’ data privacy.
Tell us about the journey Natural Cycles has had since it started and received FDA approval?
It was really my own search for alternative contraception that inspired Natural Cycles. I’ve always questioned the idea that women need to rely on synthetic hormones or methods, like the implant, which I was using at the time to avoid pregnancy. My work at CERN was winding down and I found myself at a stage in my life where I saw a future of parenthood but wasn’t quite ready for it yet. It was frustrating scrolling through medical advice around contraception and, quite frankly, the lack of non-intrusive options that were available.
I discovered that the body temperature changes throughout the menstrual cycle – something that is well-known and well-researched. I started analysing my own temperature, applying my statistical knowledge from particle physics to detect ovulation and map out my fertile days. The more entrenched I became in my fertility data, the more I was learning about my body. It really did feel like a revelation.
Using techniques I learned through the Higgs Boson project, we created an algorithm to analyse temperature readings, taking factors like sperm survival, temperature fluctuations, variations in cycle length, ovulation day, and the length of the follicular and luteal phase into account to identify fertile and non-fertile days.
Raoul (Dr Scherwitzl, Elina’s husband) was the one who suggested that we turn the fertility algorithm into an app to allow other couples to benefit from our innovation. The next essential step from there was regulating it and we’re proud to say that to date we are the first and only FDA cleared contraceptive app which is 93% effective with typical use and 98% effective with perfect use.
Can you explain how such a platform managed to get EU certification and FDA approval?
We’re a company founded on science, so it was always our mission for Natural Cycles to be viewed as such. The certification was a top priority for us. We’ve been extensively logging data and trends since the get-go, so we’re able to present our findings to the board on demand and demonstrate the effectiveness of the algorithm, and ultimately the app itself. The trends and forecast are in line with FDA guidelines, so naturally, it’s been approved. The FDA reviewed data from three clinical studies which included more than 15,000 women who used the app for approximately eight months, which is a broad sample size and gives us a strong picture of the effectiveness of the app.
As with all contraception, it’s crucial to understand that perfect-use effectiveness is a picture of what can happen if it is used completely correctly. With this in mind, our typical perfect-use effectiveness is on a par with the pill and condom. The certification validates our research.
Give us some insight into the science that goes into creating Natural Cycles?
My background is in physics, so of course a lot of what goes into the technology is driven by my own understanding of algorithms and how they can be used to map out specific outcomes. I’m well-acquainted with seeing patterns in data, so I thought it would make sense to use my knowledge and apply it to a real-life issue, which I wanted to find a practical solution for. The overall idea of mapping out menstrual cycles is by no means novel, the medical research has previously given us insight into this.
That said, it’s important to update old methods with new understanding. I did a lot of reading and found that accurate tracking of body temperature allows us to pinpoint ovulation. When body temperature raises temporarily, this is when we can identify the fertile window. Measuring this accurately and effectively was a challenge to do manually, but now we have access to technology which allows us to calculate it effectively for us. This is where my knowledge of algorithms has proven useful and it forms the basis of the app.
A woman isn’t able to become pregnant on any day of the month, but rather the ovulation day plus the five days leading up to it, due to sperm being able to survive in the woman’s body. The algorithm uses temperature, and additional data inputted into the app to determine the ovulation day and how much it varies cycle-by cycle. When the algorithm isn’t absolutely certain that the woman is outside the fertile window, it will give ‘red days’ where we recommend the use of other contraception or abstinence. When the app gives a green day, there is no need to use protection on that day.
What choice and information does it provide?
Fundamentally, the app is based upon data and the subsequent knowledge a woman can gain from it. Natural Cycles presents an alternative to intrusive and hormonal contraception – we’re offering women the choice to better understand their natural fertility patterns and ultimately, their body.
The app learns about a woman’s individual cycle daily thanks to inputted data, and the algorithm detects cycle length, ovulation day, any unusual temperature spikes or fluctuations, as well as identifying the follicular and luteal phase. It adapts to every woman’s unique cycle pattern by learning this over time as more data is added.
It also brings additional knowledge, such as a reminder of when PMS is on its way and whether the woman sometimes experience anovulatory cycles, which might make it more difficult to conceive.
Do you think a more ‘digitised’ approach towards contraception could change thinking surrounding fertility and pregnancy?
Yes. Now, more than ever before, women are taking agency over their own healthcare and their own bodies more generally. Natural Cycles offers personalised contraception which adapts to each women’s individual body – this is hugely significant for fertility and marks a shift in how people think about pregnancy and contraception.
Women have historically been provided with very little information about their own biology and anatomy, and this deprivation of knowledge is no longer acceptable in today’s society. Knowledge empowers women to better understand their bodies. There’s potential for technology to continue to enhance previous methods of contraception as we have done here at Natural Cycles, certainly. And we aim to continue our research in this area.
What action is Natural Cycles taking to address any data privacy concerns?
For us, data privacy is crucial and is indeed why users have to pay for the product. We will always ensure we responsibly handle the data they share with us. We’ve recently updated the data privacy options within the app to make it easier for users to understand and manage their consent. Sharing data or selling it to third parties goes against what we set out to do. Our user community is at the core of our work, after all, and we’re here to pioneer research that benefits them. Therefore, we must and will continue to handle their data with the responsibility it deserves.