Early Pregnancy Sample Collection Study (EPS)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Generic Protocol for the Collection of Early Pregnancy Urines|
- Collection of early pregnancy urine samples. [ Time Frame: 60 days ] [ Designated as safety issue: No ]Volunteers who become pregnant during the study will continue to collect daily urine samples until day 60 of the conception cycle.
|Study Start Date:||January 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
No Intervention: sample collection
no interventions in this sample collection study
Other: Ovulation predictions products
Home diagnostics for ovulation prediction will be provided to study volunteers
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.
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 maximum of 3 cycles. Volunteers will not be allowed to re-enter the study once they have completed 3 cycles 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 100 pregnancies and that approximately 100 volunteers will be participating at any one time. The study size may be increased or decreased to meet sample demands.