Biobank Cycle Collection
Biobank Cycle Collection Study From Women Trying to Conceive
SPD Development Company Limited
1,500 participants
Dec 6, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria11
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05642637