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Fertility Awareness App Okayed by FDA for Birth Control: What to Know About Contraception Apps
A smartphone app called Natural Cycles is paving the way for future FDA digital device clearances, though some question its effectiveness at preventing pregnancy.
By Cheryl Alkon
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August 16, 2019
The U.S. Food and Drug Administration (FDA) has an app used to track ovulation and a woman’s fertile and infertile days to be marketed as a form of contraception, as of August 10, 2019.
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The digital tool, Natural Cycles, uses information about a woman’s daily basal body temperature (taken immediately upon waking in the morning) and menstrual cycle patterns. For women who have what are considered regular menstrual periods, the app will indicate, based on bodily changes, what days she is more or less likely to be fertile.
How the Natural Cycles Product Can Be Used to Help Prevent Pregnancy
Those who do not want to be pregnant must avoid sex entirely during fertile days or use another form of contraception such as a condom to avoid pregnancy.
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Regulation of Digital Fertility Tracking Tools Is Welcome to Some
“It is a great step that the FDA is getting into this domain,” says Rachel Peragallo Urrutia, MD, an assistant professor of obstetrics and gynecology at the University of North Carolina in Chapel Hill. “It offers the opportunity for more oversight and regulation for the use of fertility apps.”
Dr. Peragallo Urrutia notes that there are other apps available that make claims about being used for contraception or to get pregnant that have not been given similar clearance by the FDA.
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How Can an Electronic App Help Prevent Pregnancy?
The digital tool is an electronic version of an approach to birth control called fertility awareness methods (FAM). These natural family planning methods are sometimes referred to as fertility charting or fertility tracking. In this process, a woman records her body’s fertility signs, such as waking body temperature or cervical mucus changes, every day for several months to predict future fertile days (times when sperm could live long enough inside a woman’s reproductive tract to meet and fertilize an egg).
How Do Fertility Awareness-Based Methods of Contraception Work?
Many different FAM types can be used to help prevent pregnancy. Basal body temperature (BBT) is one of many bodily indicators that women can use to help predict fertility days.
In general, FAM is a complicated approach that demands dedication and attention to detail to determine when a woman’s body is able to conceive. Such details include changes in BBT, cervical mucus, and the menstrual cycle.
And How Well Do Fertility Awareness Methods Work as Birth Control, Anyway?
It’s hard to say, as not much good research has been done on FAM efficacy.
Peragallo Urrutia is the lead author of a review published online inObstetrics and Gynecology August 6, 2019. Researchers evaluated 53 peer-reviewed studies that examined how well different fertility-awareness-based methods helped prevent unwanted pregnancies.
Peragallo Urrutia’s team determined that only 21 of the 53 studies were of moderate quality, 0 were high quality and 32 were low quality, concluding that “studies on the effectiveness of each fertility awareness–based method are few and of low to moderate quality.”
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The Effectiveness of Fertility Awareness Methods for Pregnancy Prevention Varies
Of the 21 studies with moderate quality, Peragallo Urrutia’s research found that most methods had varying rates of pregnancy prevention. Her study looked at different FAM options such as the standard days method, the two-day method, the Billings ovulation (cervical mucus) method, and changes in the body’s basal temperature, among others, to determine pregnancy rates. The Natural Cycles app is based on changes in BBT.
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What Is the Effectiveness of BBT, on Which the Natural Cycles App Is Based?
According to the Natural Cycles “Before You Start” page, the app “is 93 percent effective with typical use, meaning that 7 women out of 100 get pregnant during 1 year of use.”
Peragallo Urrutia says that her analysis, completed in 2019, found the BBT-based Natural Cycles prevented pregnancy up to 90 percent of the time, but notes that the FDA clearance may have been based on more current research.
Is Family Planning or Natural Birth Control Reliable?
Some caution against relying on a family planning app like Natural Cycles for birth control. “The whole realm of natural contraception has always been deemed as not being one of the safest,” said Juan Acuna, MD, an obstetrician-gynecologist at Florida International University in Miami and “one of Natural Cycles’ scientific advisers,” in a about the app’s FDA clearance.
Effectiveness Is Relative When It Comes to Birth Control
FAM, in general, does not prevent pregnancy as well as other contraception methods, such as hormonal birth control (the pill, the patch, the vaginal ring) or barrier methods like the diaphragm or condoms. FAM is considered 76 to 88 percent effective at pregnancy prevention, compared with 91 percent effectiveness for the birth control pill (aka oral contraception) and 85 percent effectiveness for condoms.
Who Should Consider Using a Contraception App?
According to the FDA press release, “Natural Cycles should not be used by women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus, or those currently using birth control or hormonal treatments that inhibit ovulation.”
The app also does not protect against sexually transmitted infections.
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What to Expect From Future Contraception Products
The Natural Cycles app is the first to gain FDA clearance as a medical device for contraception. Other fertility apps to be used as birth control will need to show “substantial equivalence to a predicate device,” or similarity to Natural Cycles’ pregnancy prevention rates, according to the FDA’s press release.
Video: Verify: Effectiveness of Natural Cycles app
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