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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clearblue Advanced Fertility Monitor | Other | Use of Clearblue Fertility Monitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clearblue Advanced Fertility Monitor | Device | Clearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one month use |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Test Result | Pregnancy test results will also be compared with both the performance of a currently marketed pregnancy test when used by a trained technician and quantitative hCG concentration. | one month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Johnson, PhD | SPD Swiss Precision Diagnostics GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPD Development Company Ltd | Bedford | Bedfordshire | MK43 7JX | United Kingdom |
Overall results will be shared after study completion
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Volunteers were instructed to test for pregnancy prior to starting the study. If pregnant before the start of their cycle they were withdrawn and classified as a pre-study pregnancy. Volunteers were also withdrawn if identified as health care professionals.
This study was conducted by volunteers remotely and managed by the clinical department at SPD. For the study, 395 females aged between 18-45 years were recruited via internet advertising and from women who had participated in previous SPD studies. The first volunteer was recruited on 1st March 2013, the last was recruited on 1st August 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fertility Monitor | Use of Clearblue Advanced Fertility Monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All volunteers recruited
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| ID | Title | Description |
|---|---|---|
| BG000 | Fertility Monitor | Use of Clearblue Fertility Monitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age of Participants who used the new Clearblue Advanced Fertility Monitor |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Volunteers whose data contributes to the full analysis set. | Posted | Number | percentage of participants | one month use |
|
|
Duration of study, one cycle per volunteer.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fertility Monitor | Use of Clearblue Fertility Monitor | 0 |
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There was some incomplete data with women not using the monitor on all the days that ideally would have been tested. We believe the missing data did not affect the objectives of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sarah Johnson, Head of Clinical and Regulatory Affairs | SPD Swiss Precision Diagnostics GmbH/SPD Development Company Ltd | 01234835486 | sarah.johnson@spdspark.com |
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| Withdrawal by SPD |
|
| Withdrawal by Subject |
|
| Health Care Professional |
|
| Removed from statistical analysis |
|
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Highest qualification | Count of Participants | Participants |
|
| Occupation | Count of Participants | Participants |
|
|
| Secondary | 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. | Volunteers who completed the study, who had daily diary entries and monitor download data for days on which a test was conducted | Posted | Number | percentage of participants | one month |
|
|
|
| Other Pre-specified | Pregnancy Test Result | Pregnancy test results will also be compared with both the performance of a currently marketed pregnancy test when used by a trained technician and quantitative hCG concentration. | Volunteers who completed the study, comparison of Clearblue Fertility Monitor pregnancy test results and a marketed pregnancy test. Results for all tests conducted. | Posted | Number | 95% Confidence Interval | percentage of tests in agreement | one month |
|
|
|
| 393 |
| 0 |
| 393 |
| 0 |
| 393 |
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