Early Pregnancy Sample Collection Study

Pregnancy Clinical Trial

— EPS  

Official title:

Generic Protocol for the Collection of Early Pregnancy Urines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577147
• Other study ID #: PROTOCOL-0400
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: December 20, 2017
• Start date: January 2012
• Est. completion date: September 2017

Study information

• Verified date: November 2016
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation prediction products to help identify their most fertile time and aid conception. Volunteers will provide SPD with a daily urine sample throughout the study period, which will be used for the development and validation of SPD products related to pregnancy and fertility.

Description:

In order to develop and validate new and existing products SPD needs to maintain a sample bank of early pregnancy urine samples from the beginning of the cycle in which pregnancy is achieved, and throughout pregnancy.

This generic study will be initiated to maintain the SPD sample bank, the study will run continuous to replenish the sample bank, as samples are used.

To obtain these samples, volunteers wishing to become pregnant will be offered the use of a Clearblue ovulation prediction product to enable them to pinpoint their most fertile time and aid conception. Whilst on the study volunteers will be asked to collect daily urine samples and return them to SPD on a regular basis in addition to keeping a daily record of menstrual cycle details and test results. Women who become pregnant during the course of the study will be asked to continue collecting daily urine samples for a minimum of a further 4 weeks. Each volunteer will be on the study for a minimum of 1 and a maximum of 3 cycles. Volunteers will not be allowed to re-enter the study once they have completed without achieving pregnancy

It is anticipated that any one of SPD's marketed ovulation prediction products may be used in this study to aid the conception rate, this may include, but not be limited to the Clearblue fertility monitor and Clearblue digital ovulation test.

It is anticipated SPD will have to recruit approximately 600 volunteers to achieve each 100 pregnancies and that approximately 500 volunteers will be participating at any one time. The study size may be increased or decreased to meet sample demands.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4025
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female, age 18-45

• Have menstrual bleeds

• Seeking to become pregnant

• Willing to provide written, informed consent

Exclusion Criteria:

• Known condition to contra-indicate pregnancy

• Having treatment for infertility.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Ovulation predictions products
Home diagnostics for ovulation prediction will be provided to study volunteers

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 early pregnancy urine samples.	Volunteers who become pregnant during the study will continue to collect daily urine samples until day 60 of the conception cycle.	60 days