Lay User Performance Evaluation of myLotus®
Research type
Research Study
Full title
Lay User Performance Evaluation of the myLotus® Ovulation (LH) and Pregnancy (hCG) tests
IRAS ID
239605
Contact name
Simon Dobson
Contact email
Sponsor organisation
Concepta Diagnostics Plc
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
The MyLotus® Fertility Monitor is a personal monitor designed to be used with disposable test sticks for the measurement of luteinising hormone (LH), the hormone involved in triggering ovulation in women's urine. This information allows women to identify their fertile window and appropriately time intercourse in order to maximise their chances of conception. The monitor also has the capability to test for pregnancy.
This study assesses the volunteer ease of use of the new MyLotus® Fertility Monitor and the understanding and interpretation of the results by the user. The study is to be conducted by volunteers at their homes and co-ordinated through local clinics.
A minimum of 100 female volunteers representing the target consumer market that have been fully informed and have provided written consent will participate in the study. This will involve volunteers setting up the monitor, using the monitor with the MyLotus® Ovulation Test for one full cycle and then setting up the monitor for their next cycle. All users will also carry out a MyLotus® Pregnancy Test alongside a currently marketed pregnancy test.
Volunteers will also complete a study questionnaire which includes sections on comprehension of the instructions for use, ease of use and interpretation of test results.
REC name
West of Scotland REC 4
REC reference
18/WS/0016
Date of REC Opinion
2 Mar 2018
REC opinion
Further Information Favourable Opinion