Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test in an Assisted Fertility Setting
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|ClinicalTrials.gov Identifier: NCT01846403|
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : May 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Embryo Transfer||Device: Semi-quantitative urine pregnancy test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test to Replace Sequential Serum hCG Testing in an Assisted Fertility Setting|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Semi-quantitative pregnancy test
Semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit)
Device: Semi-quantitative urine pregnancy test
Other Name: (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 ]
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): NCT01846403
|Ho Chi Minh City, Vietnam|
|Principal Investigator:||Nguyen Thi Nhu Ngoc, MD||Center for Research and Consultancy in Reproductive Health|
|Principal Investigator:||Ly Thai Loc, MD||Hungvuong Hospital|
|Principal Investigator:||Tara Shochet, PhD, MPH||Gynuity Health Projects|
|Principal Investigator:||Paul Blumenthal, MD, MPH||Stanford University|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|