PregnancyEPSNCT01577147
Early Pregnancy Sample Collection Study
A study testing Ovulation predictions products in people with Pregnancy, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation prediction products to help identify their most fertile time and aid conception. Volunteers will provide SPD with a daily urine sample throughout the study period, which will be used for the development and validation of SPD… 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?
- Ovulation predictions products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,025 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Sep 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, age 18-45
- Have menstrual bleeds
- Seeking to become pregnant
- Willing to provide written, informed consent
Who cannot join
- Known condition to contra-indicate pregnancy
- Having treatment for infertility.
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: Generic Protocol for the Collection of Early Pregnancy Urines
Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation prediction products to help identify their most fertile time and aid conception. Volunteers will provide SPD with a daily urine sample throughout the study period, which will be used for the development and validation of SPD products related to pregnancy and fertility.
Read the detailed description
In order to develop and validate new and existing products SPD needs to maintain a sample bank of early pregnancy urine samples from the beginning of the cycle in which pregnancy is achieved, and throughout pregnancy.
This generic study will be initiated to maintain the SPD sample bank, the study will run continuous to replenish the sample bank, as samples are used.
To obtain these samples, volunteers wishing to become pregnant will be offered the use of a Clearblue ovulation prediction product to enable them to pinpoint their most fertile time and aid conception. Whilst on the study volunteers will be asked to collect daily urine samples and return them to SPD on a regular basis in addition to keeping a daily record of menstrual cycle details and test results. Women who become pregnant during the course of the study will be asked to continue collecting daily urine samples for a minimum of a further 4 weeks. Each volunteer will be on the study for a minimum of 1 and a maximum of 3 cycles. Volunteers will not be allowed to re-enter the study once they have completed without achieving pregnancy
It is anticipated that any one of SPD's marketed ovulation prediction products may be used in this study to aid the conception rate, this may include, but not be limited to the Clearblue fertility monitor and Clearblue digital ovulation test.
It is anticipated SPD will have to recruit approximately 600 volunteers to achieve each 100 pregnancies and that approximately 500 volunteers will be participating at any one time. The study size may be increased or decreased to meet sample demands.
- Conditions
- Pregnancy
- Being tested
- Ovulation predictions products
- Keywords
- pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovulation predictions productsOther
Home diagnostics for ovulation prediction will be provided to study volunteers
| Study group | Role | What they receive |
|---|---|---|
| sample collection | Other | Ovulation prediction products provided to aid conception Receives: Other: Ovulation predictions products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of early pregnancy urine samples.
Volunteers who become pregnant during the study will continue to collect daily urine samples until day 60 of the conception cycle.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,025 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
- NCT01577147
- Sponsor's protocol ID
- PROTOCOL-0400
- Acronym
- EPS
- Status last verified
- Nov 2016
- First submitted
- 11 Apr 2012
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gadsby R, Ivanova D, Trevelyan E, Hutton JL, Johnson S. The onset of nausea and vomiting of pregnancy: a prospective cohort study. BMC Pregnancy Childbirth. 2021 Jan 6;21(1):10. doi: 10.1186/s12884-020-03478-7.
PubMed 33407214Johnson S, Marriott L, Zinaman M. Can apps and calendar methods predict ovulation with accuracy? Curr Med Res Opin. 2018 Sep;34(9):1587-1594. doi: 10.1080/03007995.2018.1475348. Epub 2018 May 25.
PubMed 29749274
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generic Protocol for the Collection of Early Pregnancy Urines
- ClinicalTrials.gov ID
- NCT01577147
- Acronym / sponsor ID
- EPS / PROTOCOL-0400
- Conditions
- Pregnancy
- Keywords
- pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,025 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2012 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Apr 2012 (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.
Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation prediction products to help identify their most fertile time and aid conception. Volunteers will provide SPD with a daily urine sample throughout the study period, which will be used for the development and validation of SPD products related to pregnancy and fertility.
Detailed description
In order to develop and validate new and existing products SPD needs to maintain a sample bank of early pregnancy urine samples from the beginning of the cycle in which pregnancy is achieved, and throughout pregnancy.
This generic study will be initiated to maintain the SPD sample bank, the study will run continuous to replenish the sample bank, as samples are used.
To obtain these samples, volunteers wishing to become pregnant will be offered the use of a Clearblue ovulation prediction product to enable them to pinpoint their most fertile time and aid conception. Whilst on the study volunteers will be asked to collect daily urine samples and return them to SPD on a regular basis in addition to keeping a daily record of menstrual cycle details and test results. Women who become pregnant during the course of the study will be asked to continue collecting daily urine samples for a minimum of a further 4 weeks. Each volunteer will be on the study for a minimum of 1 and a maximum of 3 cycles. Volunteers will not be allowed to re-enter the study once they have completed without achieving pregnancy
It is anticipated that any one of SPD's marketed ovulation prediction products may be used in this study to aid the conception rate, this may include, but not be limited to the Clearblue fertility monitor and Clearblue digital ovulation test.
It is anticipated SPD will have to recruit approximately 600 volunteers to achieve each 100 pregnancies and that approximately 500 volunteers will be participating at any one time. The study size may be increased or decreased to meet sample demands.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sample collection | Other | Other: Ovulation predictions productsOvulation prediction products provided to aid conception |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, age 18-45
- Have menstrual bleeds
- Seeking to become pregnant
- Willing to provide written, informed consent
Key exclusion criteria (2 listed)
- Known condition to contra-indicate pregnancy
- Having treatment for infertility.
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 |
|---|---|---|
| Ovulation predictions productsHome diagnostics for ovulation prediction will be provided to study volunteers | Other | sample collection |
Primary outcome
Collection of early pregnancy urine samples.
Time frame: 60 days
Volunteers who become pregnant during the study will continue to collect daily urine samples until day 60 of the conception cycle.
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 22 Dec 2017.
- Derived from this study: PubMed 33407214Gadsby R, Ivanova D, Trevelyan E, Hutton JL, Johnson S. The onset of nausea and vomiting of pregnancy: a prospective cohort study. BMC Pregnancy Childbirth. 2021 Jan 6;21(1):10. doi: 10.1186/s12884-020-03478-7.
- Derived from this study: PubMed 29749274Johnson S, Marriott L, Zinaman M. Can apps and calendar methods predict ovulation with accuracy? Curr Med Res Opin. 2018 Sep;34(9):1587-1594. doi: 10.1080/03007995.2018.1475348. Epub 2018 May 25.
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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?
A study testing Ovulation predictions products 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 4 inclusion and 2 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 22 Dec 2017. 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?
Collection of early pregnancy urine samples. (time frame: 60 days). 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 NCT01577147, which also lists 2 linked publications.
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 22 Dec 2017.