Pregnancy Clinical Trial
Official title:
Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant.
The Clearblue Fertility Monitor is a personal monitor designed to be used with disposable
test sticks for the semi-quantitative measurement of estrone-3-glucuronide (E3G) and
luteinising hormone (LH) in women's urine. This personal information allows women to identify
their fertile window and appropriately time intercourse in order to maximise their chances of
conception. A new version of this monitor (Clearblue Advanced Fertility Monitor) has been
developed with additional functionality including the option to test for pregnancy.
This study will assess the volunteer ease of use of the new Clearblue Advanced Fertility
Monitor and the understanding and interpretation of the results by the user. This is a single
centre clinical study which will be conducted by volunteers at their residence and
co-ordinated by the clinical department at SPD Development Company Ltd.
A minimum of 100 female volunteers representing the target consumer will be required to use
the new Clearblue Advanced Fertility Monitor at home as per the instructions for use. This
will involve them setting up the monitor, using the monitor for one full cycle and then
setting up the monitor for their next cycle unless they test for pregnancy and get a pregnant
result.
At the end of one full cycle, all volunteers will complete a study questionnaire which
includes sections on comprehension of the instructions for use, ease of use and
interpretation of test results.
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