Early Pregnancy Sample Collection Study (EPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01577147|
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Other: Ovulation predictions products||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4025 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Generic Protocol for the Collection of Early Pregnancy Urines|
|Actual Study Start Date :||January 2012|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||September 2017|
Ovulation prediction products provided to aid conception
Other: Ovulation predictions products
Home diagnostics for ovulation prediction will be provided to study volunteers
- Collection of early pregnancy urine samples. [ Time Frame: 60 days ]Volunteers who become pregnant during the study will continue to collect daily urine samples until day 60 of the conception cycle.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577147
|SPD Development Company Ltd|
|Bedford, Bedfordshire, United Kingdom, MK44 3UP|