PregnancyNCT01948258
Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
A study testing Clearblue Advanced Fertility Monitor in people with Pregnancy, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant. 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
- Pregnancy
- What is being tested?
- Clearblue Advanced Fertility Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 - 45 years
- Willing to provide written informed consent to participate in the study and comply to the investigational procedures
- Naive to similar marketed products including current Clearblue fertility monitor and Persona
- Two natural cycles immediately prior to entering the study, each lasting between 21 and 42 days
- Seeking to become pregnant
Who cannot join
- Unwilling to provide written informed consent to participate in the study or comply with study procedures
- Employees of SPD, Proctor \& Gamble or Alere
- Have a condition that is known to be contra-indicated in pregnancy
- Usually have menstrual cycles which are shorter than 21 days or longer than 42 days
- Using or have used in their last 2 cycles, hormonal contraceptives including oral, emergency oral, implants, patches, transdermal injections, vaginal ring and progesterone intrauterine systems (IUS)
- Using or have used in the last 2 cycles, infertility medications or hormone replacement therapy containing hCG or LH
Show all 14Show fewer
- Taking clomiphene citrate or other ovulation induction drugs
- Are using any treatment which may affect the menstrual cycle
- Have recently been pregnant, miscarried or breastfeeding
- Have been diagnosed with polycystic ovarian syndrome (PCOS)
- Are peri- or post-menopausal e.g. experiencing symptoms such as irregular menstrual periods, hot flushes, night sweats, sleep disturbances and mood swings
- Are taking antibiotics containing tetracyclines
- Have impaired liver or kidney function
- Have previously participated in a SPD 'trying to conceive' study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK43 7JX
About this study
This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant.
Read the detailed description
The Clearblue Fertility Monitor is a personal monitor designed to be used with disposable test sticks for the semi-quantitative measurement of estrone-3-glucuronide (E3G) and luteinising hormone (LH) in women's urine. This personal information allows women to identify their fertile window and appropriately time intercourse in order to maximise their chances of conception. A new version of this monitor (Clearblue Advanced Fertility Monitor) has been developed with additional functionality including the option to test for pregnancy.
This study will assess the volunteer ease of use of the new Clearblue Advanced Fertility Monitor and the understanding and interpretation of the results by the user. This is a single centre clinical study which will be conducted by volunteers at their residence and co-ordinated by the clinical department at SPD Development Company Ltd.
A minimum of 100 female volunteers representing the target consumer will be required to use the new Clearblue Advanced Fertility Monitor at home as per the instructions for use. This will involve them setting up the monitor, using the monitor for one full cycle and then setting up the monitor for their next cycle unless they test for pregnancy and get a pregnant result.
At the end of one full cycle, all volunteers will complete a study questionnaire which includes sections on comprehension of the instructions for use, ease of use and interpretation of test results.
- Conditions
- Pregnancy
- Being tested
- Clearblue Advanced Fertility Monitor
- Keywords
- Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearblue Advanced Fertility MonitorDevice
Clearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting
| Study group | Role | What they receive |
|---|---|---|
| Clearblue Advanced Fertility Monitor | Other | Use of Clearblue Fertility Monitor Receives: Device: Clearblue Advanced Fertility Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting
Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.
Measured: one month use
Secondary outcomes (1)
Correct Identification of Monitor Status
To demonstrate correct user identification of fertility status and test days and to determine the performance of the monitor in consumer hands.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study start1 Mar 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PregnancyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, PhD, Study director, SPD Swiss Precision Diagnostics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948258
- Sponsor's protocol ID
- 0481
- Status last verified
- Jan 2018
- First submitted
- 18 Sep 2013
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Overall results will be shared after study completion
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
- ClinicalTrials.gov ID
- NCT01948258
- Acronym / sponsor ID
- 0481
- Conditions
- Pregnancy
- Keywords
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant.
Detailed description
The Clearblue Fertility Monitor is a personal monitor designed to be used with disposable test sticks for the semi-quantitative measurement of estrone-3-glucuronide (E3G) and luteinising hormone (LH) in women's urine. This personal information allows women to identify their fertile window and appropriately time intercourse in order to maximise their chances of conception. A new version of this monitor (Clearblue Advanced Fertility Monitor) has been developed with additional functionality including the option to test for pregnancy.
This study will assess the volunteer ease of use of the new Clearblue Advanced Fertility Monitor and the understanding and interpretation of the results by the user. This is a single centre clinical study which will be conducted by volunteers at their residence and co-ordinated by the clinical department at SPD Development Company Ltd.
A minimum of 100 female volunteers representing the target consumer will be required to use the new Clearblue Advanced Fertility Monitor at home as per the instructions for use. This will involve them setting up the monitor, using the monitor for one full cycle and then setting up the monitor for their next cycle unless they test for pregnancy and get a pregnant result.
At the end of one full cycle, all volunteers will complete a study questionnaire which includes sections on comprehension of the instructions for use, ease of use and interpretation of test results.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clearblue Advanced Fertility Monitor | Other | Device: Clearblue Advanced Fertility MonitorUse of Clearblue Fertility Monitor |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- Aged 18 - 45 years
- Willing to provide written informed consent to participate in the study and comply to the investigational procedures
- Naive to similar marketed products including current Clearblue fertility monitor and Persona
- Two natural cycles immediately prior to entering the study, each lasting between 21 and 42 days
Key exclusion criteria (14 listed)
- Unwilling to provide written informed consent to participate in the study or comply with study procedures
- Employees of SPD, Proctor \& Gamble or Alere
- Have a condition that is known to be contra-indicated in pregnancy
- Usually have menstrual cycles which are shorter than 21 days or longer than 42 days
- Using or have used in their last 2 cycles, hormonal contraceptives including oral, emergency oral, implants, patches, transdermal injections, vaginal ring and progesterone intrauterine systems (IUS)
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 |
|---|---|---|
| Clearblue Advanced Fertility MonitorClearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting | Device | Clearblue Advanced Fertility Monitor |
Primary outcome
The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting
Time frame: one month use
Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.
1 secondary outcome
Correct Identification of Monitor Status
Time frame: one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Overall results will be shared after study completion
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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.
Sarah Johnson, PhD study director
SPD Swiss Precision Diagnostics GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clearblue Advanced Fertility Monitor in people with Pregnancy, 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 6 inclusion and 14 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 2 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?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting (time frame: one month use). 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 2 Nov 2018.