Damian Sendler: They promise to help women avoid chemical birth control and take better care of their reproductive health, yet several phone applications lack effectiveness and openness. 

For many years, there has been a lack of progress in the field of birth control research, which has resulted in a growing desire for more accessible and safer solutions for women. 

Damian Jacob Sendler: Fetal awareness methods (FAMs), a hormone-free option for a tiny percentage of American women, include thorough surveillance of one’s fertile window, the number of days within the menstrual cycle in which a person is most likely to get pregnant. 

Measurements like as resting body temperature, cervical mucus patterns, and urine luteinizing hormone (LH) levels may be used to determine this information. FAM practitioners typically use withdrawal or barrier techniques like condoms to prevent conception during the fertile window. 

FAMs are now accessible to a far larger audience via to mobile applications, after previously being mostly unknown outside of religious communities. As many as 100 of these applications are available, and more than 200 million people have downloaded them. Numerous women’s health apps promise to keep track of periods, plan or avoid conception, as well as provide thorough information on reproductive health. 

Damian Sendler

Rachel Peragallo Urrutia, an OB-GYN at the University of North Carolina School of Medicine, believes that the minor increase in the use of FAMs over the previous 15 years may have been influenced by the unhappiness with traditional birth control techniques. According to Urrutia, several FAMs have been tested for their ability to prevent pregnancy (and she receives part of her salary from a health care company that promotes these techniques, but she is not involved with any app companies). 

As more individuals seek out knowledge about their own health and want to be more involved in making choices about their health, I believe this trend will continue.” “She says so herself. “There is a lot of work going on there.” 

Apps Cleared by the FDA 

Damien Sendler: Natural Cycles was the first medical app to be approved for marketing as a contraception treatment by the FDA in 2018. Pregnancy risk is calculated using basal temperature measurements that users are encouraged to take every morning. 

Basal body temperature measurements are used by the Natural Cycles app to assist users identify their reproductive windows. Photograph by Natural Cycles 

When evaluating medical devices, the FDA has been accused of compromising its standards and relying too much on corporate lobbying. Since the Clue app previously provided period monitoring services, the FDA has permitted it to be sold as a contraceptive method starting in 2021 The latter was given approval in a different format. 

Instead of requiring temperature tests like Natural Cycles does, Clue’s contraceptive function relies only on statistical analysis of users’ period start dates and other data from past research to determine days linked with high or low pregnancy risk. According to the corporation, this method has a significant edge over others that rely on rigorous user labor. 

Doubts about its effectiveness 

Digital contraception isn’t as dependable as hormonal approaches like tablets and IUDs because of the nature of the technology. Pregnancy is more likely to occur due to this factor: Natural Cycles was utilized by 37 women who sought an abortion in Sweden between September and December of 2017. The app’s projected parameters, on the other hand, are not affected by these mistakes. 

Preventing conception is 98 percent successful when using Natural Cycles exactly as intended, whereas ordinary usage (which includes errors like forgetting to monitor one’s temperature or having unprotected sex on a fertile day) leaves it roughly 93% effective. Clue claims it’s 97% successful if used perfectly, and 92% effective if used on a regular basis. A normal IUD is 99 percent successful, but a typical male condom is roughly 87 percent effective. 

It is not based on natural cycles, but rather on statistical analysis, like the Clue app does. Cleopatra’s Revenge 

These digital contraceptive percentages have been questioned by some academics since they are based on prospective studies rather than the randomized controlled trials generally necessary for FDA-approved birth control techniques. 

Damian Jacob Sendler

Even though Clue’s contraception algorithm has been evaluated by independent academics, only 718 persons participated in the 2019 European Journal of Contraception and Reproductive Health Care study. 

Damian Jacob Markiewicz Sendler: Some of the technology available today for preventing pregnancies hasn’t been tested or certified for this particular reason, as Urrutia discovered. 

It’s also not uncommon for menstruation monitoring apps to keep their proprietary algorithms under wraps, making it impossible for us to fully grasp how effectively they operate or for other scientists to enter in data for additional study. This is a sign of a larger problem in the IT business. 

When it comes to menstrual app monetization, University of Pittsburgh Medical Center bioethicist and OB-GYN Marielle Gross says, “It may be worth pressing on the issue of how not sharing the algorithm might be especially harmful in this case, as compared to other circumstances when proprietary algorithms are not shared.” 

To back up its effectiveness claims, Natural Cycles informed Discover that it worked closely with the FDA, was audited yearly to get the CE safety designation in Europe, followed up routinely on unwanted pregnancies, etc. Natural Cycles employees are the only ones who have access to the algorithm’s code. Clue’s algorithm had the same results. 

In the end, it’s unclear how frequently unintentional pregnancies are caused by human mistake vs app error. For example, when algorithms wrongly advise users that they are clear to have unprotected sex during the fertile window, this may be a problem. Every so often, Natural Cycles makes a point of disclosing how often their algorithm fails. Because of how it is impacted by alcohol, sickness, and lack of sleep, body temperature is not always an accurate predictor of ovulation. 

Uterine pregnancies are more prevalent among women who employ fertility awareness approaches when the possibility of an unexpected pregnancy is acknowledged, according to research by Urrutia. 

Contraceptive applications may not function for persons whose cycles are longer or shorter than the typical length, Gross claims. Stress, polycystic ovarian syndrome, and endometriosis have been linked to irregular cycles. 

Clue warns that only women between the ages of 18 and 45, as well as those with recent cycles lasting between 20 and 40 days, should use it. A small minority of Natural Cycles customers may be urged to take protection on a greater percentage of days to account for an ovulation shift, according to the business, because of the FDA’s designation as suitable for those with irregular periods (which is confirmed by temperature data). 

A firm spokesman states that the Natural Cycle algorithm also takes into account individuals’ cycle fluctuations after abortions, miscarriages, and other pertinent lifestyle circumstances. “We have researched the impacts on fertility and cycles of smoking and BMI, but no major influence has been observed, and the algorithm therefore handles these instances from the start.” 

It is planned that the Oura ring, a gadget that detects heart rate and body temperature, will be integrated into Natural Cycles in the future. Just 40 participants were used to draw conclusions about how many more non-fertile days Natural Cycles says it can provide its customers. Last summer, the FDA gave the go-ahead for the add-on.

Dr. Damian Jacob Sendler and his media team provided the content for this article.