Infertility
Conditions
Brief summary
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to: 1. Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG. 2. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test. 3. Assess user comprehension of the pregnancy test, especially assessment of the result.
Detailed description
This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to: 1. Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG. 2. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test. 3. Assess user comprehension of the pregnancy test, especially assessment of the result.
Interventions
Sponsors
Gynuity Health Projects
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women 18 years or older, presenting for early abortion, pre-natal care, or fertility services. * If pregnant, gestational age \< 84 days by LMP, ultrasound or clinical assessment. * Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up. * Able to consent to study participation.
Exclusion criteria
* Women less than 18 years of age. * Women who are not pregnant, except if presenting for IVF services.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the correlation between this pregnancy test's results with serum values (as distinct from urine) hCG. 2. To assess whether or not urine concentration has any impact on the outcome | 15 minutes pregnancy test reading |
Secondary
| Measure | Time frame |
|---|---|
| To assess user comprehension of the test. | study duration |
Countries
United States
Outcome results
None listed