Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT03122951
Status:
COMPLETED
Last Update Posted:
2018-11-09
First Post:
2017-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clearblue® Advanced Ovulation Test User Study
Sponsor:
SPD Development Company Limited
Organization:
Study Overview
Official Title:
Clearblue® Advanced Ovulation Test User Study
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: