An interventional study of Semi-quantitative urine pregnancy test in Embryo Transfer, sponsored by Gynuity Health Projects. Completed at 1 site in Vietnam. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-14.
Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Health services research
Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, we 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, 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 dBest® semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on a weekly basis for up to 4 weeks after embryo transfer.
We 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. Furthermore, a pregnancy can be assured only when a yolksac or embryo could be identified thus women have to wait for a period of 2-3 weeks after the next menses expected.
We hypothesize that women seeking assisted fertility treatments will be able to monitor their hCG at home as well. Further, we plan to develop revised instructions to better suit the needs and questions we think would be relevant to women desiring to use this test as part of assisted fertility services.
We hypothesize that the simple instructions we will develop for use in this study will enable women to use the test on their own. Provider counseling will complement these instructions and contribute to overall quality of care given to each participant.
Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit)
Device: Semi-quantitative urine pregnancy test
Also known as: (dBest One Step hCG Panel Test Kit)
Document whether continuing pregnancy can be successfully monitored at home using a semi-quantitative pregnancy test
Time frame: 6 weeks
Feasibility of women using this test at home on their own as a potential future substitute or complement to standard sequential clinic-based visits to monitor pregnancy after embryo transfer.
Time frame: 6 weeks
Women's acceptability of using pregnancy tests at home instead of standard clinic-based monitoring after embryo transfer
Time frame: 6 weeks
Assess if written instructions and provider's counseling enable women using the semi-quantitative pregnancy test at home to understand how it should be used and to correctly interpret the test result
Time frame: 6 weeks
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects