Clue Birth Control

The United States Food and Drug Administration (FDA) has classified Clue Birth Control as a software application that can be used as a contraception to prevent pregnancy. We have been cleared to offer Clue Birth Control to users in the United States of America after submitting extensive information about the feature’s efficacy, the research behind it, and the processes our team has in place to make sure the app is built to the safety standards of a medical device.

The research to support the effectiveness of Clue Birth Control was conducted by the Institute for Reproductive Health (IRH) at Georgetown University. These researchers conducted a full-scale clinical trial to test the effectiveness of the Clue Birth Control algorithm used to predict high and low risk days of pregnancy.

Read the full study here.

Indications for use:

Clue Birth Control is a software application for contraception for women 18 years and older, to monitor their fertility and prevent pregnancy. Clue Birth Control is suitable for women with predictable cycles.

Please find the FDA device summary here. It discusses the device itself, its technical characteristics, and a comparison to the predicate device, Natural Cycles.

When used typically (not always used according to instructions) Clue Birth Control is 92% effective. When used perfectly (always used exactly according to instructions), Clue Birth Control is 97% effective at preventing pregnancy. This means that when Clue Birth Control is used typically, 8 out of 100 women are expected to become pregnant within one year. When used perfectly, 3 out of 100 women are expected to become pregnant within one year.

As a comparison, 85 out of 100 women who are sexually active with a male partner who produces sperm, typically get pregnant over one year without using any form of birth control.

Clue’s data and science teams created Clue Birth Control by combining population data on the menstrual cycles of women around the world with your personal data. Clue Birth Control uses a predictive algorithm which is designed to use your personal period start dates to predict which days are high or low risk for pregnancy. You'll start with 16 high risk days in your first cycle and on those days, you’ll need to use a condom every time you have sex that may result in pregnancy. Clue Birth Control gets to know your unique cycle patterns as you enter more data. After 6 cycles, you'll have an average of around 11 to 13 high risk days each cycle.

Clue Birth Control works by using your period start dates and a machine learning algorithm to identify when you might be fertile. Low risk days are days when you’re not likely to be fertile and are at low risk for becoming pregnant. High risk days are days when you are more likely to be fertile and should use a barrier method like a condom every time you have sex that may result in pregnancy. When Clue Birth Control is used typically, 8 out of 100 women are expected to become pregnant within one year. When used perfectly, 3 out of 100 women are expected to become pregnant within one year. Please remember: with the exception of abstinence, no method of contraception is 100% effective. Clue Birth Control will not protect you against Sexually Transmitted Infections (STIs).

Fertility Awareness Based Methods (FABMs) are methods of contraception that use your menstrual cycle characteristics to predict fertile days in order to know when you are at high risk for pregnancy. FABMs sometimes require monitoring other fertility markers such as cervical fluid or basal body temperature.

Clue Birth Control is similar to other FABMs in that it uses your menstrual cycle to make predictions. However, it doesn’t require you to track anything other than your period start dates in order to work effectively. Tracking your period start dates allows the app to use your individual cycle characteristics to make predictions personalized to you, making Clue Birth Control a new kind of FABM. In order to ensure efficacy of Clue Birth Control, you should always use a condom or avoid sex that may result in pregnancy on high risk days.