NCT05642637

Biobank Cycle Collection

Biobank Cycle Collection Study From Women Trying to Conceive

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 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 -80˚C until required for product development or evaluation purposes.

Conditions

• Pregnancy

Timeline

• Start date: 2022-12-06
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2022-12-08
• Last updated: 2026-04-17

Locations

1 site across 1 country: United Kingdom