https://www.npr.org/sections/health-shots/2017/07/13/536974741/mobile-app-designed-to-prevent-pregnancy-gets-e-u-approval

https://www.naturalcycles.com/

THE Natural Cycles app was designed by a particle physicist and launched in 2014. It's now been certified as a method of birth control in the E.U.

 https://www.naturalcycles.com

THERE are more than a dozen medically approved methods of birth control, including condoms, the pill and implants.

Now for the first time, a cell phone app has been certified as a method of birth control in the European Union.

Its creator, Elina Berglund, is a particle physicist who was part of the team that won the Nobel Prize in Physics in 2013. Not long after she helped discover the elusive subatomic particle known as the Higgs boson, she left her job and went searching for answers to a different mystery: how to create an app to prevent pregnancy.

Berglund had relied on a hormonal birth control implant for ten years, but she and her husband were thinking about having kids and wanted a natural way to avoid pregnancy. None of the existing apps met her standards, so the couple used math to create one. She says programming the app wasn't that different from particle physics.

“Instead of looking for the Higgs particle, you're looking at women's temperatures and fertility data, which is a lot of fun,” she says.

Berglund and her husband launched the app, Natural Cycles, in Sweden in 2014. It relies on a woman's recorded daily temperature — taken with a highly accurate thermometer — and details about menstruation to determine fertility. On days where the risk of pregnancy is high, a red light indicates you should avoid intercourse or use protection to prevent pregnancy. A green light means the risk of pregnancy is low.

Fertility tracking isn't a new idea. Dr. Paula Castaño, an OB-GYN at Columbia University, says women have been charting their periods forever.

“We've just had to use initially paper calendars, and then calendars on our phones, and ultimately now specific apps that can help us do that.”

Castaño says, in general, menstrual cycle tracking apps are popular. There are more than a thousand to choose from, and women download them for different reasons.

“It could be you just want to know when is my next period going to come, and is that going to coincide with my vacation, or can I use it to help avoid pregnancy or plan for a pregnancy,” Castaño says.

The Natural Cycles app stands out because it is the world's first to get approval by a European health agency as a contraceptive. In a clinical study of 4,000 women who used the app — along with a very sensitive thermometer called a basal body thermometer — the results were much better than traditional fertility-based awareness methods. Only seven out of 100 women got pregnant compared to about 24 out of 100 using the rhythm or calendar method.

It's still significantly less effective than other forms of birth control.

“You could argue that the app may be comparable to someone who may not be taking the pill very consistently or accurately,” says Dr. Ellen Wilson, an OB-GYN at the University of Texas Southwestern. “But if you take the pill on a regular basis and don't miss any, I don't think you're going to have a natural family planning method that is going to compare.”

Used perfectly, the pill has an effectiveness rate of 99.7 percent; however, factoring in actual use, the effectiveness rate drops to 92 percent. That's compared to 93 percent for the Natural Cycles app. The effectiveness rate of long-acting birth control, like an intrauterine device (IUD), is nearly 100 percent, and there's no need to avoid intercourse for days or even weeks of the month.

Dr. Castaño points out some women want a natural alternative.

“So it's great for them to have something that they can use that's based on some sound medical evidence,” she says. “Very few apps even have that.”

Natural Cycles has more than 300,000 users. [**more than 800,000 as of July, 2018] It costs about $10 dollars per month, although most users pay yearly at a lower rate that includes a basal body thermometer.

There are no ads, and Berglund says personal data isn't shared with any third parties. So far, most of the women who have signed up live in Northern Europe, but Berglund has her eyes on the U.S.

She says the goal isn't to replace other forms of birth control, but to provide a more accurate, mathematical update to an ancient option.

VOGUE ARTICLE June 27 2017

How was Natural Cycles born?

“Natural Cycles evolved from a personal decision to stop taking hormonal contraceptives,” says Berglund. “I couldn’t find an adequate alternative, so I started researching and discovered that you can accurately predict ovulation through body temperature, hence calculate when you’re fertile and when you’re not.”

“Using my knowledge of statistical mathematics from years as a particle physicist, I created an algorithm to predict my fertility, which I quickly realised catered to a wider need from my female friends and colleagues. Together with my husband, who is also a physicist, we turned the algorithym into an app so more women and couples could benefit.”

 “When you ovulate, the level of the hormone progesterone increases in your body, which warms it up by up to one third of a degree Celsius,” explains Berglund. “Body temperature increases at ovulation and decreases at menstruation.”

“By measuring your basal temperature – your lowest and most stable temperature within a twenty-four-hour period – you need to measure your temperature under the tongue as soon as you wake up in the morning. Really, it should be the first thing you do, before even standing up or having a drink.”

When you sign up for the Natural Cycles app, you can opt in to receive a basal thermometer, which is accurate to two decimal places – a necessary requirement when dealing with such minute temperature variations. “Since we’re looking for such a small shift in termperature, ideally you want to measure with as high precision as possible and an oral, basal thermometer offers that higher level of precision.”

Each user inputs the reading into the app and the algorithm calculates whether or not there is a risk of pregnancy. If there is a risk, the app will signal a red day, if no risk is calculated, the signal will be green.

“Every woman’s cycle is different, the algorithym gets to know you and your data. The first month you will get more red days until the algorithm has got to know you and then you will get more and more green days.” The average user should expect to see about one-third red, and two-thirds green.

Are there any side effects?

To put it simply: no. As a natural contraceptive method, it’s non hormonal and non intrusive.

How effective is it?

According to an independent study published in The European Journal of Contraception & Reproductive Health Care, the rate of false green days within the fertile window when used correctly was found to be less than 0.1 per cent - that’s more effective than male condoms (98 per cent effective) and as effective, if not more so, than the pill (>99 per cent effective). In fact, Natural Cycles has proved so effective, it is the first app to be classified as a certified contraceptive device.

“The most common source of unwanted pregnancy with Natural Cycles is when the user ignores that it’s a red day and takes the risk,” says Berglund. “At the end of the day, it’s up to the woman – as long as she’s aware of what she’s doing and has been given accurate information.”

https://www.theguardian.com/society/2018/jul/21/colossally-naive-backlash-birth-control-app

QUOTE: “We were working at Cern, looking for the Higgs boson. We applied the same statistical methods to my wife’s ovulation”.

QUOTE: “Measure in the morning as soon as you wake up and log the temperature in the app. Natural Cycles could be right for you if you can commit to measuring at least 5 times a week to help the intelligent app get to know your unique cycle.”.

“Measure in your mouth as soon as you wake up. You should aim to do this at least 5 days a week. Add your temperature and your period data into the app, you can also input additional info like LH test results and sex. It’s not essential to share all this information, but it can help the algorithm get to know your unique cycle,”

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FDA clears marketing for app used to prevent pregnancy
USA TODAY, August 10, 2018
https://www.usatoday.com/story/news/nation-now/2018/08/10/fda-approves-marketing-contraceptive-app-avoid-pregnancy/957614002/

USA TODAY NETWORK Brett Molina, USA TODAY Published 1:45 p.m. ET Aug. 10, 2018 | Updated 8:10 p.m. ET Aug. 10, 2018

The U.S. Food and Drug Administration has approved marketing for a smartphone app claiming to help prevent pregnancy.

Stockholm-based Natural Cycles bills itself as a contraception app leaning on fertility awareness, where a woman tracks the days when she is fertile based on body temperature readings and the timing of her menstrual cycle.

The app requires women who use it to check their temperature daily using a basal body thermometer. The app groups days as either green or red. During red days, users are advised to avoid sex or use protection such as a condom.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” said Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, in a statement Friday.

According to the Natural Cycles website, the app has proven to be 93 percent effective at preventing unwanted pregnancies.

Cornelison also warns despite the high effectiveness rate, Natural Cycles isn’t a foolproof solution. ”Women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”

Questions have been raised over whether this app is as effective in preventing pregnancy as its makers claim. The U.K.-based Advertising Standards Authority announced in June it was launching an investigation into Natural Cycles after reports women became pregnant while using it, reports the Guardian.

In January, the app faced investigation from Swedish medical authorities after 37 women who used the app became pregnant, reports The Verge. 

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