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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 -80ËšC until required.
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 information including demographic and clinical data e.g. menses days, volunteer age and reproductive hormone concentrations.
Study volunteers, seeking to conceive will be recruited to the study after providing written informed consent. All volunteers will be provided with a CE marked 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 confirmed 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 up to 3 consecutive menstrual cycles if not pregnant and up to sample day 60 if pregnant.
Urine samples will be received in the clinical laboratory and will be tested for the presence of hormones related to pregnancy and fertility, then aliquoted and stored in the SPD Biobank at -80ËšC until required for product development or evaluation purposes.
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| Measure | Description | Time Frame |
|---|---|---|
| Collection of daily urine samples from women trying to conceive | Daily samples collected throughout the cycle in which conception occurs | From recruitment until sample collection complete (up to 3 menstrual cycles if not pregnant and sample day 60 if pregnant) |
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Inclusion Criteria:
Exclusion Criteria:
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Women trying to conceive
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Weddell | Contact | 01234 835000 | 35162 | sarah.weddell@spdspark.com |
| Sharon Bond | Contact | 01234 835000 | 35524 | sharon.bond@spdspark.com |
| Name | Affiliation | Role |
|---|---|---|
| Raniero Zazzeroni | SPD Development Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPD Development Company Ltd | Recruiting | Bedford | Bedfordshire | MK44 3UP | United Kingdom |
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Early morning urine samples