RecruitingNCT05642637

Biobank Cycle Collection

Biobank Cycle Collection Study From Women Trying to Conceive


Sponsor

SPD Development Company Limited

Enrollment

1,500 participants

Start Date

Dec 6, 2022

Study Type

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

Sex: FEMALEMin Age: 18 Years

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)

SPD Development Company Ltd

Bedford, Bedfordshire, United Kingdom

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NCT05642637


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