Clearblue® Advanced Ovulation Test User Study

Trying to Conceive Population Clinical Trial

Official title:

Clearblue® Advanced Ovulation Test User Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122951
• Other study ID #: PROTOCOL-0917
• Status: Completed
• Phase: N/A
• Start date: April 21, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: September 2018
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Trying to Conceive Population

Intervention

Diagnostic Test:
• ovulation test use
Normal use of The Clearblue® Advanced Ovulation Test according to Information for use instructions

Locations

Country	Name	City	State
United Kingdom	SPD Development Company Ltd	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of users who score the product above average according to the system usability score after 4 weeks of usage	=95% of volunteers score 68 or higher on the usability scale after 4 weeks of usage or at the point of withdrawal from the study	4 weeks
Secondary	agreement between lay-user interpretation of the test result and the test result as stored in the users account	agreement between lay-user interpretation of the test result and the test result as stored in the users account	4 weeks
Secondary	Within and between volunteer experience of using the product	Intra and inter-volunteer experience of using the product as recorded on a satisfaction scale in the volunteer diary	4 weeks
Secondary	level of lay-user interaction with the product	The average number of times an individual volunteer interacts with the product throughout a cycle and an understanding of when the interaction is at its highest	4 weeks
Secondary	Product ease of use and comprehension of instructions for use	The cumulative Likert scored for the end of study system usability questions	4 weeks