Pregnancy
Conditions
Keywords
Pregnancy
Brief 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.
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.
Interventions
DEVICEClearblue Advanced Fertility Monitor
Clearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting
Sponsors
SPD Development Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correct Identification of Monitor Status | one month | To demonstrate correct user identification of fertility status and test days and to determine the performance of the monitor in consumer hands. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Test Result | one month | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Fertility Monitor Use of Clearblue Fertility Monitor | 233 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete by cut-off date | 35 |
| Overall Study | Health Care Professional | 43 |
| Overall Study | Lost to Follow-up | 27 |
| Overall Study | Pregnancy | 41 |
| Overall Study | Removed from statistical analysis | 2 |
| Overall Study | Withdrawal by SPD | 8 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Fertility Monitor |
|---|---|
| Age, Customized Age of Participants 18-25 | 38 Participants |
| Age, Customized Age of Participants 26-30 | 68 Participants |
| Age, Customized Age of Participants 31-35 | 64 Participants |
| Age, Customized Age of Participants 36-40 | 56 Participants |
| Age, Customized Age of Participants 41-45 | 7 Participants |
| Highest qualification A levels, vocational level 3 and equivalents (age | 55 Participants |
| Highest qualification Degree or equivalent (college degree) | 77 Participants |
| Highest qualification GCSE (Grade A*-C), vocational level 2 and equivale | 41 Participants |
| Highest qualification No qualifications | 5 Participants |
| Highest qualification Other higher education below degree level (associa | 20 Participants |
| Highest qualification Other qualifications | 8 Participants |
| Highest qualification Post-graduate qualifications | 25 Participants |
| Highest qualification Qualifications at level 1 and below | 2 Participants |
| Occupation Administrative / Secretarial | 24 Participants |
| Occupation Associate Professional / Technical | 27 Participants |
| Occupation Homemaker | 32 Participants |
| Occupation Managerial | 23 Participants |
| Occupation Manufacturing / Driver | 0 Participants |
| Occupation Other | 12 Participants |
| Occupation Personal Services | 8 Participants |
| Occupation Professional | 59 Participants |
| Occupation Sales / Customer Services | 29 Participants |
| Occupation Skilled Trade | 4 Participants |
| Occupation Student | 4 Participants |
| Occupation Support Personnel | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian : Bangladeshi | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian : Chinese | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian : Indian | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian : Other Asian | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian : Pakistani | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian : South Asian | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black: African | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black: Caribbean | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black: Other Black | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Mixed | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White: American | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White: Australian/New Zealander | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White: Eastern European | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White: Mediterranean/Middle Eastern | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White: Other White | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White: Western European | 210 Participants |
| Sex: Female, Male Female | 233 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 393 |
| other Total, other adverse events | 0 / 393 |
| serious Total, serious adverse events | 0 / 393 |
Outcome results
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.
Time frame: one month use
Population: Volunteers whose data contributes to the full analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fertility Monitor | The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting | 89.7 percentage of 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.
Time frame: one month
Population: Volunteers who completed the study, who had daily diary entries and monitor download data for days on which a test was conducted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fertility Monitor | Correct Identification of Monitor Status | 91.2 percentage of participants |
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.
Time frame: one month
Population: Volunteers who completed the study, comparison of Clearblue Fertility Monitor pregnancy test results and a marketed pregnancy test. Results for all tests conducted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fertility Monitor | Pregnancy Test Result | Monitor test result in agreement with predicate | 99.3 percentage of tests in agreement |
| Fertility Monitor | Pregnancy Test Result | Monitor test result in agreement with hCG levels | 100 percentage of tests in agreement |