Trying to Conceive Population Clinical Trial
Official title:
Clearblue® Advanced Ovulation Test User Study
The Clearblue® Advanced Ovulation Test is designed for home use by women who are either
planning or trying for a pregnancy.
The purpose of this protocol is to demonstrate that lay-users representative of the target
user population are able to use the product in the intended user environment.
The Clearblue Advanced Ovulation Test is designed for home use by women who are trying to get
pregnant now or in the near future. It identifies those days in a woman's cycle on which
intercourse is most likely to lead to conception.
The product defines three phases of fertility through urine hormone measurement: Low (small
chance of conceiving), High (increased chance of conceiving) which is achieved by the
detection of a rise in the level of estrone-3-glucuronide and Peak (highest chance of
conceiving) which provides an early warning of impending ovulation through detection of the
luteinising hormone surge which precedes it by 24 - 36 hours.
This protocol aims to demonstrate the successful usage of the Clearblue Advanced Ovulation
Test product by lay-users in the intended environment.
Elements of system usability, product satisfaction and ease of use will be used to assess
overall product performance in lay-user hands.
Lay users will be required to user the product according to the instructions for use for a
mimimum of 1 complete menstrual cycle after which they will be required to provide feedback
on product use.
A usability scale which focusses on providing subjective feedback from users. This is a
simple ten-item attitude Likert scale which each volunteer will complete after 4 weeks of
product use. The primary endpoints of this study will focus on the use of this scoring scale
to determine the usability of the product in lay-user hands.
;