NCT03719846

Brief Summary

This study will provide urine cycles from both pregnant and not pregnant volunteers to maintain the SPD sample bank. Study volunteers, seeking to conceive will be provided with 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 1 menstrual cycle. Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts at stored at -80˚C until required. The study will also gather optional information from volunteers regarding a woman's general health and stress levels when trying to conceive. This will be used to study the relationship between general health, stress and conception.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

October 23, 2018

Last Update Submit

November 1, 2022

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Collection of urine samples during conception cycle

    Daily during samples collected throughout the cycle in which conception occurs

    2 years

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Females aged 18-40 years actively trying to conceive
  • At least 2 regular consecutive cycles since last pregnancy/miscarriage/or since stopping breastfeeding
  • Willing to disclose their pregnancy status and provide urine samples.
  • Willing to give informed consent and comply with the investigational procedures.

You may not qualify if:

  • Conditions that contraindicated pregnancy
  • Taking medication, or has known condition which means they should not get pregnant.
  • Currently pregnant or breastfeeding
  • Abnormal liver or kidney function
  • Taking antibiotics containing tetracycline.
  • Previously participated in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples collected during study

Study Officials

  • sarah Johnson

    SPD Development company Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 25, 2018

Study Start

November 5, 2018

Primary Completion

October 28, 2020

Study Completion

August 31, 2021

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations

GB(1)