Product Trials

Cambridge Temperature Concepts will shortly begin trials of our DuoFertility device, a continuous temperature logger for identifying ovulation in women trying to conceive. The aim of this trial is to compare the usability of the DuoFertility device to existing products on the market. This is not a clinical trial, and will simply involve the testing of usability rather than effectiveness of the devices.

The trial recruitment will start during October 2007, and will last 4 cycles of ovulation and menstruation or until pregnancy is achieved. We aim to include around 100 women in the trial, spread over a range of ages, lifestyles, and medical histories. In order to allow personal visits to trial volunteers, we will be allocating most trial positions to women within the UK, however a number of places are available for international testing.

Why a usability trial?

We believe that the most important feature of our product is convenience, and that this will directly lead to higher quality data and thus more accurate ovulation detection. By not requiring women to take measurements every day or at a particular time of day, we believe that the quality of data will be dramatically improved because no data will be lost, and therefore the accuracy of ovulation detection will be enhanced.

In order to test this chain of reasoning, we first have to verify that the product is in fact convenient. During the trial, women will be provided with one of our prototype devices, as well as a commercially available device to compare it with. We will ask the women to use both devices as directed, and report their experiences to us via a series of online surveys.

Our prototype device includes PC software that performs data analysis and displays your daily temperature, as well as showing other relevant information such as expected days of ovulation and menstruation.

What kind of data will we collect?

Potential trial volunteers are asked to first fill in a pre-trial questionnaire, which contains personal, demographic and medical information. This will allow us to ensure that a range of different types of women are included in the trial, to ensure that our final product suits as many lifestyles as possible. All potential trial volunteers will need to confirm that they have discussed this trial with their family doctor, and that their doctor is happy for them to participate. At this stage we aim to include around 100 women in the trial, and potential trial volunteers will be notified by email if they are to be included.

Trial volunteers will be provided with a commercial ovulation detector, our prototype device, and a set of login codes to our web-site. We intend to personally visit each UK trial participant at the beginning and end of the trial, and will also provide a series of on-line surveys to all participants over the course of the trial. Participants will be asked to periodically submit the results of the commercial device online (e.g. temperatures as measured each morning by a commercial BBT thermometer), and to allow our prototype device to send data to us over the internet. Our prototype device collects several different types of temperature measurement, as well as measurements of body movement in order to indicate quality of sleep.

The data collected for each participant will be coded with a number rather than a name, and a list maintained to link the individual (e.g. Mrs. Smith) to the trial participant number (e.g. ABC123). This list of codes is then kept safe and only referred to when absolutely necessary. By using this system our scientists can analyse the data from all participants without anyone being personally identified, however should a question need to be asked of a participant (e.g. "Were you sick with a fever from 20-25 January?") or by your doctor (e.g. "Could you please provide Mrs. Smith's daily temperature data for the last two months?") then we have the ability to allow this to happen.

What is the cost involved?

The trial will be free to participants. We will provide both a commercial ovulation detector and one of our prototype devices free of charge, and these will be yours to keep. We will attempt to visit you at your convenience at both the start and end of the trial, and will regularly communicate with you through the internet.

How do I join the trial?

Simply fill in the pre-trial questionnaire, and we will let you know when we select the participants for the trial (during November and December 2007). We will also keep you updated on trial developments.