Status:
RECRUITING
Biobank Cycle Collection
Lead Sponsor:
SPD Development Company Limited
Conditions:
Pregnancy
Eligibility:
FEMALE
18+ years
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 Cl...
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 informatio...
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
Key Trial Info
Start Date :
December 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05642637
Start Date
December 6 2022
End Date
January 1 2028
Last Update
April 17 2026
Active Locations (1)
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1
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom, MK44 3UP