The era of contraceptive apps has arrived, but would you use an app for contraception?

By Darya Kozlyk 

The Medical-device App Revolution

Recent years have illuminated a trend towards a health conscientious society among some populations in developed countries, with the United Kingdom being a prime example. Organic good and veganism is exploding in popularity, and some people are embracing a healthier, more active lifestyle in the awake of the current obesity pandemic. This lifestyle shift is being propagated by an explosion of smartphone applications in fitness and healthcare, which have become integrated as a vital component in many people’s daily lives. Interestingly, health conscientious living has transitioned into the field of women’s health, namely contraception. With the ‘Mooncup’ menstrual cup recently regaining popularity, it is reasonable to assume that some women want to extend a more natural style of living to their contraceptive needs.

Fertility awareness based methods (FABMs) have been utilised by women long before the revolution of hormonal contraception, which has largely overshadowed FABMs due to its superior effectiveness at preventing unintended pregnancies. However, due to growing demand, FABMs delivered through smartphone applications have recently regained interest with women. With over 40 apps currently available for download, the vast majority are fertility tracking apps, which utilise user logged data on cycle length symptomology. One app, however, takes this to the next level by advertising itself as a contraceptive tool.

‘NaturalCycles’

By far the most popular FABM app on the market, with over 1 million downloads, is ‘NaturalCycles’. With the additional component of a two decimal basal thermometer and a unique algorithm, it is the only certified medical device intended for use as a contraceptive in Europe. This puts the CE marked app in the same risk category as condoms, and even the contraceptive pill.

At £49.99, the app includes a two decimal basal thermometer which, solely requires input of basal temperature immediately after waking up, allowing the unique algorithm to calculate and display either non-fertile ‘green day’ (indicating that it is safe to have unprotected sex and avoid pregnancy) or fertile ‘red day’ results, thereby conveying risk of pregnancy and need for barrier protection. For an additional £22.42 per 20 sticks, an add-on of luteinising hormone urine dipstick is available to increase the number of ‘green days’, and therefore allow more sexual freedom.

The Science Behind the App

Based on logged basal temperature, the app’s algorithm calculates infertile days pre and post ovulation, as well as alert the user to the 6 fertile days during the cycle. This is based on the premise that basal body temperature is positively correlated with rising progesterone levels around the time of ovulation. Therefore, monitoring basal body temperature rise may indicate impending ovulation. Previous scientific research has given plausibility to this method, and although the temporal relationship of which has been well-studied, the mechanism is not fully understood.

The websites’ dedicated science behind the app section signposts readers to two pieces of scientific research supporting this app. The first article confirms that the algorithm predicts fertile and non-fertile days to the same accuracy as clinical tests, such as ultrasound scans, and as such, can be used for fertility awareness purposes. The second article build on this, by repeatedly reiterating that when compared to traditional non-app based FABMs, ‘NaturalCycles’ is a superiorly reliable contraceptive, and can even match the effectiveness of the pill.

Reading Between the Lines, and you will find flaws, big ones.

The research conclusions appear to be an easy sell- “contraception without side-effects”. However, the conclusions drawn were based on only the 30% of women who logging unintended pregnancies into the app, thereby leaving the authors to draw significant assumptions as to the pregnancy status of the remaining 70% of women. This, along with women only using the app for an average of 6.3 cycles before quitting, results in a significant lack of information from which to derive a valid conclusion as to the efficacy of the app. More worryingly, the over-emphasised statement reiterating the superiority of the app compared to traditional FABMs is entirely inaccurate. Reading the results section more closely reveals the authors self-proclaim that extrapolated data estimates 52.8% of women will become pregnant over the span of 10 years of use. This puts ‘NaturalCycles’ at the bottom end of the contraceptive efficacy rank. If this is not shocking enough, the biggest concern with this research is the inherent bias; it was funded by the ‘NaturalCycles’ company. The authors, who are employees with stock shares, performed the analysis of results and drew conclusions. This highlights a major conflict of interest, and momentously threatens the validity of results.

Verdict

We are living in an era of apps, with an app available to almost entirely suite our every need. Copious examples are evident of well thought through, innovative apps which are plugging the gap in the market. However, when it comes to healthcare, such apps need a sound evidence base, in order to support business expansion, clientele growth, and instil public confidence. Although ‘NaturalCycles’ had made an admirable attempt to do so, the current research presented in flawed and therefore an inappropriate source of information for women to make an informed decision.