8th February, 2017

Leading sexual and reproductive health experts have responded to news that the Natural Cycles fertility awareness app has been approved as a class IIb medical device.

The Faculty of Sexual and Reproductive Health of the Royal College of Obstetricians and Gynaecologists (FSRH), sexual health charity FPA, and Dr Cecilia Pyper of the University of Oxford and FertilityUK said that fertility awareness apps have great potential to broaden contraception choice but warned that being classed as a medical device does not guarantee that the app will effectively prevent pregnancy.

They called for more large-scale, independent trials of fertility apps and their effectiveness, to ensure that apps that aim to prevent pregnancy are based on the same rigorous scientific research as other contraceptive methods.

Natural Cycles and other fertility awareness apps are based on fertility awareness methods (also known as natural family planning) which involve monitoring different indicators of fertility in order to establish which days are fertile days (days that a woman could conceive).

Diana Mansour, Vice President, Clinical Quality, FSRH said

“There are hundreds of apps which claim to help users plan or prevent a pregnancy – these come in all manner of forms and some will be more effective than others. Without independent evaluation we can’t say for certain which will be effective at achieving this.

“Women who wish to use fertility awareness-based contraception are advised to receive guidance from a qualified teacher to learn how to effectively monitor the different indicators. Apps currently do not come with this teaching, leaving room for misunderstanding and inaccurate use.

“As well as requiring regular, consistent monitoring of fertility indicators, all fertility awareness-based contraceptive methods rely on women abstaining from sex or using condoms correctly during the fertile window. If women don’t follow these instructions perfectly, their risk of pregnancy greatly increases.”

Natika H Halil at FPA said:

“It’s important when considering contraception that women aren’t misled into thinking that non-hormonal contraception, whether that’s the IUD, condoms or fertility awareness, is always a better choice than hormonal contraception.

“Although hormonal contraception has some potential side-effects and health risks, it can also have a range of benefits such as controlling menstrual bleeding, reducing PMS symptoms and managing acne.

“If women are concerned about their hormonal contraception we recommend speaking to a health professional about alternative methods.

“The IUD (copper coil) is a highly-effective non-hormonal method that can last for up to 10 years and doesn’t rely on a woman remembering to take or use it.”

Dr Cecilia Pyper said:

“There are currently hundreds of fertility apps and period trackers and no independent 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.”

-ENDS-

Notes to editors

Fertility apps that aim to prevent pregnancy are based on fertility awareness methods, also known as natural family planning.

Natural family planning is more effective when a number of different fertility indicators are monitored, including the length of the cycle, daily waking temperature and cervical secretions.

Apps that rely on fewer fertility indicators may not be as effective at predicting a woman’s fertile days.

Fertility Awareness Methods require women to abstain from sex, or use another method of contraception such as condoms on fertile days.

A retrospective study published in 2016, carried out by Natural Cycles suggests a Pearl Index of 7 for typical use (how a woman is likely to use the app) compared with 0.5 for perfect use (correct and consistent use every time). However, the study had a high dropout rate (34%) and was not able to establish the pregnancy outcomes of all women involved.

NHS Choiced did an analysis of the study.

The full published study identified disadvantages including the fact that it was a retrospective study of short duration with a high dropout rate.

Contraception