PregnancyCSCNCT03719846
Continuous Sample Collection Study
An observational study of Pregnancy, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank. Study volunteers, seeking to conceive will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception. 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
- How many people
- 558 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2018to 31 Aug 2021
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Females aged 18-40 years actively trying to conceive
- At least 2 regular consecutive cycles since last pregnancy/miscarriage/or since stopping breastfeeding
- Willing to disclose their pregnancy status and provide urine samples.
- Willing to give informed consent and comply with the investigational procedures.
Who cannot join
- Conditions that contraindicated pregnancy
- Taking medication, or has known condition which means they should not get pregnant.
- Currently pregnant or breastfeeding
- Abnormal liver or kidney function
- Taking antibiotics containing tetracycline.
- Previously participated in this study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
About this study
This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank.
Study volunteers, seeking to conceive will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception. All volunteers will provide daily early morning urine samples throughout the study period and keep a study diary of menses and pregnancy test results for 1 menstrual cycle.
Read more
Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts at stored at -80˚C until required.
The study will also gather optional information from volunteers regarding a woman's general health and stress levels when trying to conceive. This will be used to study the relationship between general health, stress and conception.
Read the detailed description
This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank.
Study volunteers, seeking to conceive will be recruited to the study after providing written informed consent. All volunteers will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception and be required to collect daily early morning urine samples throughout the study until pregnancy is conformed or their next menstrual period starts. Volunteers will be required to keep a daily diary of menses, sample collection and pregnancy test results. The study will last for 1 menstrual cycle.
Urine samples will be received in the clinical laboratory will be tested for the presence of hormones related to pregnancy and fertility, then aliquoted into 2.25ml amounts at stored in the SPD BioBank at -80˚C until required for product development or evaluation .
The study will also gather optional information from volunteers regarding a woman's general health and stress levels when trying to conceive. This will be used to study the relationship between general health, stress and conception.
Demographic data will be summarised. No statistical analysis will be conducted on the data.
- Conditions
- Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of urine samples during conception cycle
Daily during samples collected throughout the cycle in which conception occurs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start5 Nov 2018
- Primary completion28 Oct 2020
- Study completion31 Aug 2021
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
- Other
- Time perspective
- Prospective
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- sarah Johnson, Study director, SPD Development company Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719846
- Sponsor's protocol ID
- PROTOCOL-1015
- Acronym
- CSC
- Status last verified
- Nov 2022
- First submitted
- 23 Oct 2018
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Sample Collection Study
- ClinicalTrials.gov ID
- NCT03719846
- Acronym / sponsor ID
- CSC / PROTOCOL-1015
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 25 Oct 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.
This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank.
Study volunteers, seeking to conceive will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception. All volunteers will provide daily early morning urine samples throughout the study period and keep a study diary of menses and pregnancy test results for 1 menstrual cycle.
Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts at stored at -80˚C until required.
The study will also gather optional information from volunteers regarding a woman's general health and stress levels when trying to conceive. This will be used to study the relationship between general health, stress and conception.
Detailed description
This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank.
Study volunteers, seeking to conceive will be recruited to the study after providing written informed consent. All volunteers will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception and be required to collect daily early morning urine samples throughout the study until pregnancy is conformed or their next menstrual period starts. Volunteers will be required to keep a daily diary of menses, sample collection and pregnancy test results. The study will last for 1 menstrual cycle.
Urine samples will be received in the clinical laboratory will be tested for the presence of hormones related to pregnancy and fertility, then aliquoted into 2.25ml amounts at stored in the SPD BioBank at -80˚C until required for product development or evaluation .
The study will also gather optional information from volunteers regarding a woman's general health and stress levels when trying to conceive. This will be used to study the relationship between general health, stress and conception.
Demographic data will be summarised. No statistical analysis will be conducted on the data.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- Females aged 18-40 years actively trying to conceive
- At least 2 regular consecutive cycles since last pregnancy/miscarriage/or since stopping breastfeeding
- Willing to disclose their pregnancy status and provide urine samples.
- Willing to give informed consent and comply with the investigational procedures.
Key exclusion criteria (6 listed)
- Conditions that contraindicated pregnancy
- Taking medication, or has known condition which means they should not get pregnant.
- Currently pregnant or breastfeeding
- Abnormal liver or kidney function
- Taking antibiotics containing tetracycline.
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
Collection of urine samples during conception cycle
Time frame: 2 years
Daily during samples collected throughout the cycle in which conception occurs
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 2 Nov 2022.
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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 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?
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 4 inclusion and 6 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 2 Nov 2022. 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 urine samples during conception cycle (time frame: 2 years). 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 2 Nov 2022; AzTrials last refreshed its copy on 3 Nov 2026.