Biobank Cycle Collection
BCC
1 other identifier
observational
1,500
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedStudy Start
First participant enrolled
December 6, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 17, 2026
April 1, 2026
5.1 years
November 30, 2022
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collection of daily urine samples from women trying to conceive
Daily samples collected throughout the cycle in which conception occurs
From recruitment until sample collection complete (up to 3 menstrual cycles if not pregnant and sample day 60 if pregnant)
Eligibility Criteria
Women trying to conceive
You may qualify if:
- 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
You may not qualify if:
- 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®)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP, United Kingdom
Biospecimen
Early morning urine samples
Study Officials
- STUDY DIRECTOR
Raniero Zazzeroni
SPD Development Company
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 8, 2022
Study Start
December 6, 2022
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share