Trying to Conceive PopulationNCT03122951
Clearblue® Advanced Ovulation Test User Study
A study testing ovulation test use in people with Trying to Conceive Population, run by SPD Development Company Limited at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trying to Conceive Population
- What is being tested?
- ovulation test use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2017to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
About this study
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.
Read the 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.
- Conditions
- Trying to Conceive Population
- Being tested
- ovulation test use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovulation test useDiagnostic test
Normal use of The Clearblue® Advanced Ovulation Test according to Information for use instructions
| Study group | Role | What they receive |
|---|---|---|
| ovulation test use | Other | All voluteers will receive device for use according to instructions Receives: Diagnostic Test: ovulation test use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (4)
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
Measured: 4 weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
Product ease of use and comprehension of instructions for use
The cumulative Likert scored for the end of study system usability questions
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start21 Apr 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trying to Conceive PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122951
- Sponsor's protocol ID
- PROTOCOL-0917
- Status last verified
- Sep 2018
- First submitted
- 18 Apr 2017
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearblue® Advanced Ovulation Test User Study
- ClinicalTrials.gov ID
- NCT03122951
- Acronym / sponsor ID
- PROTOCOL-0917
- Conditions
- Trying to Conceive Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ovulation test use | Other | Diagnostic Test: ovulation test useAll voluteers will receive device for use according to instructions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ovulation test useNormal use of The Clearblue® Advanced Ovulation Test according to Information for use instructions | Diagnostic test | ovulation test use |
Primary outcome
proportion of users who score the product above average according to the system usability score after 4 weeks of usage
Time frame: 4 weeks
≥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 secondary outcomes
agreement between lay-user interpretation of the test result and the test result as stored in the users account
Time frame: 4 weeks
Within and between volunteer experience of using the product
Time frame: 4 weeks
level of lay-user interaction with the product
Time frame: 4 weeks
Product ease of use and comprehension of instructions for use
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ovulation test use in people with Trying to Conceive Population, run by SPD Development Company Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of users who score the product above average according to the system usability score after 4 weeks of usage (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.