Embryo Transfer Clinical Trial
Official title:
Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care,
the investigators would like to document the feasibility and acceptability of a
semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring
protocols to offer women and health care providers a new choice of diagnostic tools to
confirm early pregnancy. The pilot will help us to better understand how this tool
complements existing monitoring protocols. If a suitable addition or replacement to repeat
blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make
assisted fertility treatments more patient-friendly. This study seeks to test this
innovation by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test
(Athenium Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks
after egg retrieval/embryo transfer or intrauterine insemination.
The investigators hypothesize that the test, which can be used at home by women, will
provide confirmation of the presence of a pregnancy compared with standard serum hCG testing
because 1) it has sensitivity and specificity that correlates well with serum testing, and
2) it can be used at home and thus earlier to determine presence of hCG.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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