PregnancyNCT03424590
Connected Ovulation Test Efficacy Study
A study testing Clearblue Connected Ovulation Test System in people with Pregnancy, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who are either planning or trying for a pregnancy. This study will determine the difference in pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Clearblue Connected Ovulation Test System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2018to 19 Sep 2018
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Actively trying to conceive
- At least 2 regular consecutive cycles since last pregnancy/ miscarriage/ or since stopping breastfeeding
- Willing to use their own smartphone for the duration of this study and to download and install the study app
- Willing to disclose their pregnancy status and provide urine samples to test markers related to pregnancy and fertility
- Have internet access on their phone for the duration of the study
- Willing to give informed consent and comply with the investigational procedures
Who cannot join
- Currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G, or affiliates
- Has an immediate relative* currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G or affiliates
- There is a reason why the volunteer should not get pregnant e.g. they are taking a medication or have a medical condition which means they should not get pregnant
- Trying to conceive for more than 6 months (if less than 35 years old) and more than 3 months (if 35 years old or over)
- Has been diagnosed with Polycystic Ovarian Syndrome (PCOS)
- Has PCOS symptoms: very irregular cycles, hirsutism
Show all 15Show fewer
- Using or has previously used infertility medications or hormone replacement therapy containing hCG or LH (e.g Pregnyl)
- Are taking clomiphene citrate or other ovulation induction drugs
- Using any treatment which may affect the menstrual cycle (e.g. the contraceptive pill)
- Currently pregnant or breastfeeding
- Peri- or post-menopausal, e.g. experiencing symptoms: Irregular menstrual periods, hot flushes, night sweats, sleep disturbances, and mood swings
- Have abnormal liver or kidney function
- Taking medication containing tetracycline
- Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as IVF or ICSI
- Has a phone that is known to be incompatible with COTS
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
About this study
Official title: Libera Efficacy 2 Cycles at Home Study
Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who are either planning or trying for a pregnancy. This study will determine the difference in pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to assist with conception.
- Conditions
- Pregnancy
- Being tested
- Clearblue Connected Ovulation Test System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearblue Connected Ovulation Test SystemDevice
Urinary LH test to predict ovulation
| Study group | Role | What they receive |
|---|---|---|
| COTS | Active comparator | Volunteers will be provided with Clearblue connected Ovulation test system to use during the study period, accortding to the instructions for use. Receives: Device: Clearblue Connected Ovulation Test System |
| Control | No intervention | Volunteers will not be provided with Clearblue Connected Ovulation Test System and will be instructed not to use any other ovulation predictions tests during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention.
The difference in pregnancy rates between volunteers trying to conceive in the home setting using (i) COTS (ii) no intervention
Measured: 2 months
Secondary outcomes (2)
Assessment of behaviour of women trying to conceive
Quantitative assessment in methods used to try and help with conception and intercourse patterns.
Measured: 2 months
Evaluation of women's experience of trying to conceive using COTS compared to not using ovulation tests
Qualitative interview responses regarding usage and experience of COTS or other methods whilst trying to conceive.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start29 Jan 2018
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Dr, Study director, SPD Development Company Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424590
- Sponsor's protocol ID
- PROTOCOL-0987
- Status last verified
- Jul 2018
- First submitted
- 25 Jan 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Johnson S, Bond S, Grace B, Marriott L. Increased Chance of Live Birth Following Use of Connected Ovulation Test System: Outcome Results from a Randomized Controlled Trial. Womens Health Rep (New Rochelle). 2022 Jan 31;3(1):60-66. doi: 10.1089/whr.2021.0102. eCollection 2022.
PubMed 35136878
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Libera Efficacy 2 Cycles at Home Study
- ClinicalTrials.gov ID
- NCT03424590
- Acronym / sponsor ID
- PROTOCOL-0987
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 7 Feb 2018 (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.
Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who are either planning or trying for a pregnancy. This study will determine the difference in pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to assist with conception.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COTS | Active comparator | Device: Clearblue Connected Ovulation Test SystemVolunteers will be provided with Clearblue connected Ovulation test system to use during the study period, accortding to the instructions for use. |
| Control | No intervention | –Volunteers will not be provided with Clearblue Connected Ovulation Test System and will be instructed not to use any other ovulation predictions tests during the study period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Actively trying to conceive
- At least 2 regular consecutive cycles since last pregnancy/ miscarriage/ or since stopping breastfeeding
- Willing to use their own smartphone for the duration of this study and to download and install the study app
- Willing to disclose their pregnancy status and provide urine samples to test markers related to pregnancy and fertility
- Have internet access on their phone for the duration of the study
Key exclusion criteria (15 listed)
- Currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G, or affiliates
- Has an immediate relative* currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G or affiliates
- There is a reason why the volunteer should not get pregnant e.g. they are taking a medication or have a medical condition which means they should not get pregnant
- Trying to conceive for more than 6 months (if less than 35 years old) and more than 3 months (if 35 years old or over)
- Has been diagnosed with Polycystic Ovarian Syndrome (PCOS)
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 Connected Ovulation Test SystemUrinary LH test to predict ovulation | Device | COTS |
Primary outcome
Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention.
Time frame: 2 months
The difference in pregnancy rates between volunteers trying to conceive in the home setting using (i) COTS (ii) no intervention
2 secondary outcomes
Assessment of behaviour of women trying to conceive
Time frame: 2 months
Evaluation of women's experience of trying to conceive using COTS compared to not using ovulation tests
Time frame: 2 months
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 19 Oct 2018.
- Derived from this study: PubMed 35136878Johnson S, Bond S, Grace B, Marriott L. Increased Chance of Live Birth Following Use of Connected Ovulation Test System: Outcome Results from a Randomized Controlled Trial. Womens Health Rep (New Rochelle). 2022 Jan 31;3(1):60-66. doi: 10.1089/whr.2021.0102. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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, Dr study director
SPD Development Company Ltd.
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 Connected Ovulation Test System 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 15 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 19 Oct 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?
Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03424590, which also lists 1 linked publication.
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 19 Oct 2018.