Collection of urine samples from women trying to conceive
Biobank Cycle Collection Study From Women Trying to Conceive
SPD Development Company Limited · NCT05642637
This study is collecting daily urine samples from women trying to get pregnant to learn more about fertility and help with future research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | SPD Development Company Limited (industry) |
| Locations | 1 site (Bedford, Bedfordshire) |
| Trial ID | NCT05642637 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect daily urine samples from women who are actively trying to conceive to support the SPD biobank. Participants will use a Clearblue Ovulation product to identify their most fertile days and will document their menstrual cycles and pregnancy test results over a period of up to three cycles. The collected urine samples will be analyzed for reproductive hormones and stored for future research and product development. The study seeks to gather valuable data on fertility and conception.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and over who are actively trying to conceive and meet specific eligibility criteria.
Not a fit: Patients who have been trying to conceive for an extended period or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of fertility and improve resources for women trying to conceive.
How similar studies have performed: While this approach is observational and may not have been extensively tested in this exact format, similar studies have successfully gathered fertility-related data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bedford, Bedfordshire
- SPD Development Company Ltd — Bedford, Bedfordshire, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Sarah Weddell
- Email: sarah.weddell@spdspark.com
- Phone: 01234 835000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy, Fertility, Trying to Conceive