Continuous Sample Collection Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

558 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-05

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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 recruited to the study after providing written informed consent. All volunteers will be provided with Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception and be required to collect daily early morning urine samples throughout the study until pregnancy is conformed or their next menstrual period starts. Volunteers will be required to keep a daily diary of menses, sample collection and pregnancy test results. The study will last for 1 menstrual cycle.

Urine samples will be received in the clinical laboratory will be tested for the presence of hormones related to pregnancy and fertility, then aliquoted into 2.25ml amounts at stored in the SPD BioBank at -80˚C until required for product development or evaluation .

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.

Demographic data will be summarised. No statistical analysis will be conducted on the data.

Conditions

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Pregnancy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes