By Veronica Leach
March 27, 2019

Introduction
The number of apps geared toward women’s health continues to rise, but few of them have been tested for efficacy. This ‘femtech’ industry is expected to be a fifty billion dollar industry by 2025; with apps used for family planning and health tracking, proof of efficacy is essential.[i] To this end, some companies and universities have partnered to set standard protocols for this growing field. One such partnership led to an efficacy study of the Dynamic Optimal Timing (Dot) fertility tracking application developed by Cycle Technologies. The company asked Georgetown University’s Institute of Reproductive Health (IRH) to study the efficacy of this app using guidelines from contraceptive efficacy studies.[ii] The unique nature of a fertility app required Georgetown researchers to apply guidelines normally used in a clinical setting to the remote platform of an app. This interface allowed researchers to gather real-time data, assessing pregnancy probability prospectively from daily inputs.

Technology Meets Fertility Awareness Based Methods
The Dot app is based on Dynamic Optimal TimingTM, an algorithm-based method that uses known fertility data, vetted fertility data sets, and the individual user’s period-start dates to determine pregnancy risk for each day of her cycle. The app starts out conservatively with a wide window of fertility and refines its determinations as the user continues to add period-start dates. The app interprets pregnancy risk for the user. For women avoiding pregnancy, it marks each day as either High or Low.  For women planning pregnancy, the pregnancy chances are marked as High, Medium or Low.[iii]

Researchers at Georgetown’s IRH collaborated with EastBanc Technologies to design a digital platform to gather data and communicate seamlessly with the study participants. Through this app, women were asked if they wanted to participate and were screened for eligibility, informed consent was obtained, and daily inputs were gathered.

Methodology
A total of 718 women were enrolled who met the inclusion criteria of being 18-39 years of age, sexually active with a male partner, avoiding pregnancy, and capable of becoming pregnant.[iv] Throughout 13 menstrual cycles, women self-reported start dates of their menstrual periods, pregnancy intention each cycle, and daily coital decisions. They also completed four surveys about their satisfaction with their relationships and use of the Dot fertility app.[v] To calculate efficacy, women were separated into categories of perfect use (avoiding sex and/or using condoms during the fertile window) and typical use (having sex during the fertile window using no method, withdrawal, emergency contraception, or another method). IRH researchers then calculated perfect- and typical-use failure rates using life-table analysis.

Results
When all participants had completed 6 full cycles, a paper was published detailing the initial results. A total of 3,245 cycles were collected from 419 participants after 6 full cycles. With all pregnancies attributable to imperfect use, the typical-use pregnancy rate was calculated to be 3.5%.[vi]

The final study[vii] of the efficacy of the Dot fertility app was published this month in The European Journal of Contraception & Reproductive Health Care. At the completion of the 13-cycle study, data was collected from 6,616 menstrual cycles from all women included in the study, with 336 women remaining in the study for 13 consecutive months from the original 718 enrolled.[viii] The perfect-use failure rate was calculated to be 1% and the typical-use failure rate was 5%.

Discussion
This prospective analysis providing real-time insights into user habits and desires as well as how women interact with a fertility app platform is the first of its kind. It has laid a framework for future studies of efficacy of women’s health apps, an increasing priority for organizations like USAID that recognize the importance of informed choice and providing effective technologies for women’s health and family planning for FABM users. With digital technology predicted to play an even greater role in the future of women’s health, it is essential to test and ensure the effectiveness of new tools available for women.

Editor’s Note: This innovative technology and the effectiveness rates documented in this initial study hold promise. Yet, like all research, this study does have some limitations. Although 718 women met inclusion criteria and were enrolled, data was collected from only 419 women 6 months later. By the end of the 13 cycles, 336 women remained in the study (53% of women who enrolled did not complete the study).

The Dot app was developed by the Cycle Technologies team, who also developed the Standard Days Method, an FABM that is easy to teach and simple to use. Many women may not even know such family planning methods are available but may benefit from FABMs through the use of technology like Dot. Perhaps these women would consider using an FABM if they knew the algorithms used in technology like the Dot are founded on a sound understanding of a woman’s reproductive physiology—which is the basis for all FABMs.

Furthermore, many peri-menopausal women may choose FABMs to avoid pregnancy or would be interested in FABMs to avoid the risk of blood clots and other adverse effects with hormonal birth control. Yet, the inclusion criteria for the Dot study excluded women older than 39. Expanding the criteria to include older women could be a consideration for a future study design.

Also, as explained in the study, the Dot app sends a woman “notifications at the beginning and end of her fertile window, (alerting) her to upcoming changes in her fertility status and (reminding) her to avoid intercourse or use a condom to prevent pregnancy on high-risk days.” However, the results did not differentiate between couples using condoms and those choosing to abstain from sexual relations during or near the fertile window identified by the app. Likewise, it seems the perfect-use data included condom use, another factor that future studies could attempt to delineate further (especially since adding the use of condoms may decrease the effectiveness of most FABMs, since condoms have a lower effectiveness rate than many FABMs). Like FABMs and hormonal contraception, the Dot fertility app is not 100% effective, with a perfect-use failure rate of 1 in 100 women.

A more thorough analysis is beyond the scope of this brief summary. Yet, even with these limitations, this pioneering study assesses the efficacy of a reasonable, hormone-free approach for family planning in women and couples seeking to avoid pregnancy. In July 2016, FACTS published “The Performance of Fertility Awareness-based Method Apps Marketed to Avoid Pregnancy.” In our study, we did not rank apps with proprietary algorithms highly, since they lacked research supporting their effectiveness. However, that will not be the case with the new Dot app, as we now have effectiveness data. We celebrate the availability of additional safe and effective family planning choices for women and look forward to more studies like this one.

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Author Bio: Veronica Leach is a research fellow at FACTS and an independent contractor at Georgetown IRH. Her work with the IRH team involves analysis of Dot app data and writing papers with the institute. Veronica earned a master’s degree in public health from George Washington University and a bachelor’s degree in biomedical engineering from Rutgers University.

 

 

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References
[i] Altman, A. (2018) ‘The Unlikely Politics of a Digital Contraceptive | The New Yorker’, The New Yorker, p. Annals of Technology. Available at: https://www.newyorker.com/tech/annals-of-technology/the-unlikely-politics-of-a-digital-contraceptive (Accessed: 20 November 2018).

[ii] Simmons, R. G. et al. (2018) ‘Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol’. doi: 10.2196/resprot.6886.

[iii] Simmons, R. G. et al. (2018) ‘Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol’. doi: 10.2196/resprot.6886.

[iv] Shattuck, D., Haile, L. T. and Simmons, R. G. (2018) ‘Lessons From the Dot Contraceptive Efficacy Study: Analysis of the Use of Agile Development to Improve Recruitment and Enrollment for mHealth Research.’, JMIR mHealth and uHealth. JMIR mHealth and uHealth, 6(4), p. e99. doi: 10.2196/mhealth.9661.

[v] Simmons, R. G. et al. (2018) ‘Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol’. doi: 10.2196/resprot.6886.

[vi] Jennings, V. H. et al. (2018) ‘Estimating six-cycle efficacy of the Dot app for pregnancy prevention.’ doi: 10.1016/j.contraception.2018.10.002.

[vii] Victoria Jennings, Liya T. Haile, Rebecca G. Simmons, Jeff Spieler & Dominick Shattuck (2019) Perfect- and typical-use effectiveness of the Dot fertility app over 13 cycles: results from a prospective contraceptive effectiveness trial, The European Journal of Contraception & Reproductive Health Care, DOI: 10.1080/13625187.2019.1581164

 

FACTS Spring Conference!

In response to the growing interest in FABMs,
the FACTS team planned three one-day conferences in 2019.

Join us in Indianapolis this weekend or in Dallas in October
to learn about timely issues in women’s reproductive health!

Fertility Awareness for Precision Women’s Health Care

FACTS members save 20% to attend our Spring Conferences.

Registration is STILL OPEN for Indianapolis on April 5th.

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April 5, 2019
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The Female Cycle
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The Science Behind
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Monday, Apr 8 
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The Signs of
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Fertility Awareness Based
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