PregnancyBCCNCT05642637
Biobank Cycle Collection
An observational study of Pregnancy, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
This study will provide daily urine samples from volunteers who are trying to conceive in order to maintain the SPD biobank. Study volunteers, seeking to conceive will be provided with a CE marked 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 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2022to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women trying to conceive
Who may be able to join
- Females aged 18 and over actively trying to conceive
- At least 2 regular consecutive cycles since last pregnancy/miscarriage/ stopping breastfeeding or contraception
- Willing to disclose their pregnancy status and provide urine samples.
- Willing to give informed consent and comply with the study procedures
Who cannot join
- Trying to conceive for >6 months (under 35 years) or > 3 months (35 years and over)
- Has a diagnosis of Polycystic Ovary Syndrome (PCOS)
- Taking medication or has known condition which means they should not get pregnant.
- Currently pregnant or breastfeeding
- Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
- Using or has previously used infertility medications or hormone replacement medications containing LH or hCG \ (e.g. Pregnyl®)
Show all 11Show fewer
- Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as IVF or ICSI
- Peri-or post-menopausal, e.g. experiencing symptoms: irregular menstrual periods, hot flushes, night sweats, sleep disturbances and/or moods swings
- Abnormal liver or kidney function
- Taking antibiotics containing tetracycline.
- Participated in this study within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
Sarah Weddell, 01234835000, sarah.weddell@spdspark.com
Jackie Boxer, 01234835000, jackie.boxer@spdspark.com
About this study
Official title: Biobank Cycle Collection Study From Women Trying to Conceive
This study will provide daily urine samples from volunteers who are trying to conceive in order to maintain the SPD biobank.
Study volunteers, seeking to conceive will be provided with a CE marked 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 up to 3 menstrual cycles.
Urine samples will be received in the clinical laboratory and aliquoted and stored at -80˚C until required.
Read the detailed description
The purpose if this study is to maintain the SPD Biobank with urine samples from cycles in which conception occurred and ones where conception did not occur, together with associated sample information including demographic and clinical data e.g. menses days, volunteer age and reproductive hormone concentrations.
Study volunteers, seeking to conceive will be recruited to the study after providing written informed consent. All volunteers will be provided with a CE marked 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 confirmed 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 up to 3 consecutive menstrual cycles if not pregnant and up to sample day 60 if pregnant.
Urine samples will be received in the clinical laboratory and will be tested for the presence of hormones related to pregnancy and fertility, then aliquoted and stored in the SPD Biobank at -80˚C until required for product development or evaluation purposes.
- Conditions
- Pregnancy
- Keywords
- Fertility, Trying to Conceive
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of daily urine samples from women trying to conceive
Daily samples collected throughout the cycle in which conception occurs
Measured: From recruitment until sample collection complete (up to 3 menstrual cycles if not pregnant and sample day 60 if pregnant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start6 Dec 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raniero Zazzeroni, Study director, SPD Development Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642637
- Sponsor's protocol ID
- PROTOCOL-1388
- Acronym
- BCC
- Status last verified
- Apr 2026
- First submitted
- 30 Nov 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobank Cycle Collection Study From Women Trying to Conceive
- ClinicalTrials.gov ID
- NCT05642637
- Acronym / sponsor ID
- BCC / PROTOCOL-1388
- Conditions
- Pregnancy
- Keywords
- Fertility, Trying to Conceive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 Dec 2022 (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 daily urine samples from volunteers who are trying to conceive in order to maintain the SPD biobank.
Study volunteers, seeking to conceive will be provided with a CE marked 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 up to 3 menstrual cycles.
Urine samples will be received in the clinical laboratory and aliquoted and stored at -80˚C until required.
Detailed description
The purpose if this study is to maintain the SPD Biobank with urine samples from cycles in which conception occurred and ones where conception did not occur, together with associated sample information including demographic and clinical data e.g. menses days, volunteer age and reproductive hormone concentrations.
Study volunteers, seeking to conceive will be recruited to the study after providing written informed consent. All volunteers will be provided with a CE marked 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 confirmed 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 up to 3 consecutive menstrual cycles if not pregnant and up to sample day 60 if pregnant.
Urine samples will be received in the clinical laboratory and will be tested for the presence of hormones related to pregnancy and fertility, then aliquoted and stored in the SPD Biobank at -80˚C until required for product development or evaluation purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women trying to conceive
Key inclusion criteria (4 listed)
- Females aged 18 and over actively trying to conceive
- At least 2 regular consecutive cycles since last pregnancy/miscarriage/ stopping breastfeeding or contraception
- Willing to disclose their pregnancy status and provide urine samples.
- Willing to give informed consent and comply with the study procedures
Key exclusion criteria (11 listed)
- Trying to conceive for >6 months (under 35 years) or > 3 months (35 years and over)
- Has a diagnosis of Polycystic Ovary Syndrome (PCOS)
- Taking medication or has known condition which means they should not get pregnant.
- Currently pregnant or breastfeeding
- Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
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 daily urine samples from women trying to conceive
Time frame: From recruitment until sample collection complete (up to 3 menstrual cycles if not pregnant and sample day 60 if pregnant)
Daily samples collected throughout the cycle in which conception occurs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Not yet recruitingObservational study
Comparison of Beta-hCG Levels When Using Venous Puncture Blood and Peripheral Finger Stick Blood
Pregnancy
RecruitingPhase 2/3
Impact of Standardization on Outcomes Following Cervical Ripening
Pregnancy
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.
Raniero Zazzeroni study director
SPD Development Company
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 11 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Weddell (01234 835000 ext. 35162, sarah.weddell@spdspark.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of daily urine samples from women trying to conceive (time frame: From recruitment until sample collection complete (up to 3 menstrual cycles if not pregnant and sample day 60 if pregnant)). 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 17 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.