Phone app that challenges the Pill is approved in EU

Organisation: Position: Deadline Date: Location:

ContraceptivePlanningFocus

A phone app has been granted medical approval to be used as a contraceptive in the European Union in a breakthrough that could spell the end for hormonal and intrusive birth control measures. But, warns Dr Cecilia Pyper of Oxford University and  Fertility UK,  ‘There are currently hundreds of fertility apps and period trackers and … research suggests that many are ineffective.’

Sexual health experts say more research is needed into the effectiveness of fertility tracking apps in preventing pregnancy. BBC News reports that the warning comes after the first such app – Natural Cycles – was given an official approval as a method of contraception.

In 2015 an industry-sponsored (Natural Cycles Nordic AB) study showed that the app was as effective as the pill.

The report says the app works by getting women to enter their body temperatures, ovulation test results and date of menstruation. An algorithm (a set of rules to help solve a problem, run by computer software) then determines whether a woman is fertile on that day. This should help her make a decision about having unprotected sex.

But, the report says, while sexual experts agreed fertility awareness apps have great potential to broaden contraception choice – three organisations warned that being classed as a medical device doesn’t guarantee the app will effectively prevent pregnancy.

The sexual health charity FPA, the faculty of sexual and reproductive health of the Royal College of Obstetricians and Gynaecologists and Dr Cecilia Pyper of the University of Oxford and Fertility UK said that these kind of apps often have complicated instructions that need to be strictly followed, if they are to be effective.

Natural Cycles was approved as a class IIb medical device by Tüv Süd, which means it can now be marketed as a hormone-free, non-invasive contraceptive option.

Dr Elina Berglund, co-founder of Natural Cycles, 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. Our high quality clinical studies, together with the required regulatory approvals, means we can provide women everywhere with a new option for contraception.”

The report quotes Pyper as saying, however, that more research needs to be done into fertility apps. “There are currently hundreds of fertility apps and period trackers and no system to evaluate these technologies, which are changing at a very fast pace. The research we do have suggests that many are ineffective at accurately predicting a woman’s fertile days. Large, independently-conducted prospective trials are needed before apps can be considered for contraceptive use.”

Abstract
Objectives: The aim of the study was to evaluate the ability of a novel web and mobile application to identify a woman’s ovulation day and fertile window, in order to use it as a method of natural birth control.
Methods: A retrospective study was performed on 1501 cycles of 317 women aged 18 to 39 years. Women entered their basal body temperatures, ovulation test results and date of menstruation into the application.
Results: The mean delay from the first positive ovulation test to the temperature-based estimation of the ovulation day was 1.9 days; the length of the luteal phase varied on average by 1.25 days per user. Only 0.05% of non-fertile days were falsely attributed and found within the fertile window.
Conclusions: The method is effective at identifying a user’s ovulation day and fertile window and can therefore be used as a natural method of birth control.

Author

Elina Berglund

BBC News report
The European Journal of Contraception & Reproductive Health Care


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