| NCT ID | NCT05642637 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SPD Development Company Limited |
| Condition | Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2022-12-06 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2022-12-06 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 & Investigator
Raniero Zazzeroni
STUDY DIRECTOR
SPD Development Company
Frequently Asked Questions
Who can join the NCT05642637 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05642637 currently recruiting?
Yes, NCT05642637 is actively recruiting participants. Contact the research team at sarah.weddell@spdspark.com for enrollment information.
Where is the NCT05642637 trial being conducted?
This trial is being conducted at Bedford, United Kingdom.
Who is sponsoring the NCT05642637 clinical trial?
NCT05642637 is sponsored by SPD Development Company Limited. The principal investigator is Raniero Zazzeroni at SPD Development Company. The trial plans to enroll 1,500 participants.