Mobile app Natural Cycles approved as contraceptive

February 13, 2017

Natural Cycles offers women a hormone-free alternative from daily oral tablet
A woman measures her temperature to find out whether it is a red or green day
Green = 99.9% safe, while the app advises couples use a condom on red days
German-based certification body Tuv Sud approved it as a Class IIb device

James Draper For Mailonline

Published:
05:50 EST, 9 February 2017

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Updated:
02:36 EST, 13 February 2017

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An contraception app that uses body temperature to track a woman’s menstrual cycle has been given the seal of approval.

Natural Cycles records daily temperature and uses an algorithm to plot fertility on a calendar.

In a clinical study of 4,000 women in 2016, it was claimed to be as effective as the contraceptive pill.

Now, German-based regulator Tuv Sud has approved it as a Class IIb medical device – the same level as acupuncture needles and blood bags.

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Natural Cycles records daily temperature and uses an algorithm to plot fertility on a calendar

The app is believed to be the first software of its kind to be certified as a contraception alongside condoms, the pill and intrauterine devices (IUDs).

Dr Elina Berglund, who created the app with her husband Dr Raoul Scherwitzl, said: ‘Women around the world are interested in exploring effective non-hormonal, non-invasive forms of contraception.

‘And now they have a new, clinically verified and regulatory approved option to choose from.’

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A growing number of wearable devices and software have appeared that focus on female health and fertility, but none have previously been certified as clinically viable.

‘Our high quality clinical studies, together with the required regulatory approvals, means we can provide women everywhere with a new option for contraception,’ Dr Berglund added.

‘Natural Cycles allow women to better understand their bodies so they can make choices that are right for them.’

In a clinical study of 4,000 women in 2016, it was claimed to be as effective as the contraceptive pill (pictured husband and wife Dr Elina Berglund and Dr Raoul Scherwitzl who created the app)

The app is believed to be the first software of its kind to be certified as a contraception alongside condoms, the pill and intrauterine devices

Natural Cycle uses a woman’s temperature to predict the days of the month when she is at her most fertile.

On these, red days, the app advises a couple use a condom to reduce the risk of becoming pregnant.

In the days leading up to ovulation, a woman’s body is flooded by oestrogen, which cools the body, compared with the post-ovulatory stage.

During that second stage of the menstrual cycle, after ovulation, the hormone progesterone warms the body, raising its temperature.

The two phases are separated by ovulation day – when a woman is at her most fertile – when the body’s temperature rises between 0.2 and 0.45°C.

Currently, uncontrollable mood-swings, spontaneous bouts of crying even a loss of libido are common complaints of the Pill.

There have also been associated risks with strokes, with a 2016 study published in the British Medical Journal suggesting that third generation pills raise the chance of a serious blood clot four fold.

But the drugs safety watchdog, the Medicines and Healthcare products Regulatory Agency, said contraceptive pills are ‘very safe, highly effective medicines’ and a review had confirmed the risk of blood clots with all contraceptives is small.