NCT03719846

Continuous Sample Collection Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 558 (actual)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

• Pregnancy

Timeline

• Start date: 2018-11-05
• Primary completion: 2020-10-28
• Completion: 2021-08-31
• First posted: 2018-10-25
• Last updated: 2022-11-02

Locations

1 site across 1 country: United Kingdom