PregnancyNCT02535260
Clearblue Advanced Fertility Monitor Consumer Three Cycle at Home Study
An observational study of 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 in a home setting for three menstrual cycles or until pregnancy is achieved (whichever comes first) 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
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento 11 Apr 2014
- Phase
- Observational
- 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
Study population: women wishing to become pregnant
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
- 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
- Trying to conceive for12 months (for volunteers under 35) or trying to conceive for >6 months ( for volunteers 35 or older)
- 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
- 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 in a home setting for three menstrual cycles or until pregnancy is achieved (whichever comes first) 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 Advance Fertility Monitor) has been developed with enhanced functionality including the option to test for pregnancy.
This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home setting by female volunteers seeking to become pregnant, for three menstrual cycles or until pregnancy is achieved (whichever comes first). 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.
The overall objective of the study will be to demonstrate the usage of the new Clearblue Advanced Fertility Monitor in a home setting, to assess the benefits of monitor usage and to compare monitor data to laboratory analyses on the same urine samples.
In order to achieve these objectives, a minimum of 200 female volunteers representing the target consumer will be recruited 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 the duration of the study..
All volunteers will be required to complete a daily diary and to collect a daily urine sample. Volunteers who become pregnant on the study will be asked to continue to collect urine samples. At the end of the study all volunteers will complete a study questionnaire which includes questions relating to monitor usage and knowledge and behaviour regarding conception. Upon return to SPD, the urine samples will be tested by auto-analyser for various hormones.
- Conditions
- Pregnancy
- Keywords
- Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fertility Monitor | Clearblue Fertility Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural change
To compare change in behaviour from self-reported baseline behaviour to that reported in daily diaries including intercourse frequency, personal fertility knowledge and pregnancy testing behaviour
Measured: 3 months
Behavioural change
To observe % compliance of conducting tests
Measured: 3 months
User comprehension
To assess user comprehension of the Instructions for use
Measured: 3 months
Product performance
To assess performance of the Clearblue Advanced Fertility Monitor at identification of fertile window in relation to quantitative LH and E3G measurements
Measured: 3 months
product performance
To compare pregnancy test results to quantitative hCG concentration
Measured: 3 months
Secondary outcomes (2)
Behavioural change
To examine pregnancy test results qualitative assessment of women's behaviour in monitor usage following early pregnancy loss, should this occur during the study
Measured: 3 month
Pregnancy rate
To examine pregnancy rate in relation to baseline demographics, intercourse pattern during the study and expected pregnancy rate based on published literature
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Primary completion11 Apr 2014
Why it stopped: Study not started, no longer required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT02535260
- Sponsor's protocol ID
- PROTOCOL-0682
- Status last verified
- Feb 2019
- First submitted
- 18 Sep 2013
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearblue Advanced Fertility Monitor Consumer Three Cycle at Home Study
- ClinicalTrials.gov ID
- NCT02535260
- Acronym / sponsor ID
- PROTOCOL-0682
- Conditions
- Pregnancy
- Keywords
- Pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not started, no longer required
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Primary completion
- 11 Apr 2014 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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.
This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home setting for three menstrual cycles or until pregnancy is achieved (whichever comes first) 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 Advance Fertility Monitor) has been developed with enhanced functionality including the option to test for pregnancy.
This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home setting by female volunteers seeking to become pregnant, for three menstrual cycles or until pregnancy is achieved (whichever comes first). 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.
The overall objective of the study will be to demonstrate the usage of the new Clearblue Advanced Fertility Monitor in a home setting, to assess the benefits of monitor usage and to compare monitor data to laboratory analyses on the same urine samples.
In order to achieve these objectives, a minimum of 200 female volunteers representing the target consumer will be recruited 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 the duration of the study..
All volunteers will be required to complete a daily diary and to collect a daily urine sample. Volunteers who become pregnant on the study will be asked to continue to collect urine samples. At the end of the study all volunteers will complete a study questionnaire which includes questions relating to monitor usage and knowledge and behaviour regarding conception. Upon return to SPD, the urine samples will be tested by auto-analyser for various hormones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fertility Monitor | – | –Clearblue Fertility Monitor |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women wishing to become pregnant
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)
- 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
- Trying to conceive for12 months (for volunteers under 35) or trying to conceive for >6 months ( for volunteers 35 or older)
- 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.
Primary outcome
Behavioural change
Time frame: 3 months
To compare change in behaviour from self-reported baseline behaviour to that reported in daily diaries including intercourse frequency, personal fertility knowledge and pregnancy testing behaviour
Behavioural change
Time frame: 3 months
To observe % compliance of conducting tests
User comprehension
Time frame: 3 months
To assess user comprehension of the Instructions for use
Product performance
Time frame: 3 months
To assess performance of the Clearblue Advanced Fertility Monitor at identification of fertile window in relation to quantitative LH and E3G measurements
product performance
Time frame: 3 months
To compare pregnancy test results to quantitative hCG concentration
2 secondary outcomes
Behavioural change
Time frame: 3 month
Pregnancy rate
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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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.
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?
An observational study of 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: withdrawn, as of the sponsor's last update on 8 Feb 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Behavioural change (time frame: 3 months). The study lists 5 primary outcomes in all. 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 8 Feb 2019.