Performance Evaluation Study for Clearblue Pregnancy Test
Performance Evaluation Study for Clearblue Pregnancy Test
The purpose of this study is to collect urine samples and dating scan information from women
 who wish to become pregnant. Urine samples will be tested in the laboratory with the
 Clearblue Pregnancy Test and the results correlated with volunteer information.
Approximately 800 female volunteers wishing to become pregnant will be recruited locally
 around 5 trial centers within the US.

 Daily urine samples and gestational age dating scan information obtained from the study will
 be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product
 assessment will involve testing of early morning urine samples collected by women during the
 cycle in which they conceived. Urine samples will be collected pre-conception to the end of
 the second trimester.
Inclusion Criteria:

 -  Provide written informed consent to participate in the study and agree to comply with
 study procedures.

 -  Has menstrual bleeds.

 -  Seeking to become pregnant.

 -  Intend to seek medical care during pregnancy.

 Exclusion Criteria:

 -  Has positive pregnancy test on screening.

 -  Has received medical treatment for infertility or is participating in an assisted
 fertility program.

 -  Known condition to contra-indicate pregnancy.