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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SPD Development Company Ltd

Bedford, Bedfordshire, United Kingdom, MK44 3UP

Biobank Cycle Collection | DecenTrialz