Continuous Sample Collection Study

Pregnancy Clinical Trial

— CSC  

Official title:

Continuous Sample Collection Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719846
• Other study ID #: PROTOCOL-1015
• Status: Completed
• Start date: November 5, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2022
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: August 31, 2021
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United Kingdom	SPD Development Company Ltd	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of urine samples during conception cycle	Daily during samples collected throughout the cycle in which conception occurs	2 years