Clinical trial NCT03122951: Clearblue® Advanced Ovulation Test User Study
Official title: Clearblue® Advanced Ovulation Test User Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trying to Conceive Population
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 577
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Female Aged 18 to 45 years Trying to conceive, planning to conceive in the next year or interested in using an ovulation testing system.

Willing to provide written informed consent to participate in the study. Has menstrual cycles.

Exclusion Criteria:

Pregnant, recently pregnant or breastfeeding Diagnosed with Polycystic Ovarian Syndrome Use of hormonal contraception Use of hormone replacement therapy Use of any other medical treatment for fertility such as ovulation drugs, artificial insemination, assisted fertility such as IVF, ICSI Currently or previously employed by SPD, Alere, Unipath or P and G, or affiliates Has an immediate relative currently or previously employed by SPD, Alere, Unipath or P and G or affiliates

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Primary outcomes:
measure: proportion of users who score the product above average according to the system usability score after 4 weeks of usage
timeFrame: 4 weeks
Secondary outcomes:
measure: agreement between lay-user interpretation of the test result and the test result as stored in the users account
timeFrame: 4 weeks
measure: Within and between volunteer experience of using the product
timeFrame: 4 weeks
measure: level of lay-user interaction with the product
timeFrame: 4 weeks
measure: Product ease of use and comprehension of instructions for use
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
References: