Clearblue® Advanced Ovulation Test User Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

577 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2017-10-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trying to Conceive Population

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ovulation test use

All voluteers will receive device for use according to instructions

Group Type OTHER

ovulation test use

Intervention Type DIAGNOSTIC_TEST

Normal use of The Clearblue® Advanced Ovulation Test according to Information for use instructions

Interventions

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ovulation test use

Normal use of The Clearblue® Advanced Ovulation Test according to Information for use instructions

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes