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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semi-quantitative urine pregnancy test | Other | Semi-quantitative urine pregnancy test (Quanti5 Multilevel hCG Pregnancy Test) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-quantitative urine pregnancy test | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of SQPT results that accurately monitor pregnancy | Participants will have follow-up visits that include serum hCG testing and ultrasounds to confirm pregnancy. Will be able to compare these results to the results of the at-home pregnancy test. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of women using this test at home | 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 or IUI. Forms given to document their results at home will include questions on feasibility. Exit interview will also include questions regarding feasibility. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Westphal, MD | Division of Reproductive Endocrinology and Infertility Stanford University School of Medicine | Principal Investigator |
| Paul Blumenthal, MD, MPH | Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of Medicine | Principal Investigator |
| Wendy Sheldon, MPH, MSW, PhD | Gynuity Health Projects | Principal Investigator |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28830483 | Derived | Shochet T, Comstock IA, Ngoc NTN, Westphal LM, Sheldon WR, Loc LT, Blum J, Winikoff B, Blumenthal PD. Results of a pilot study in the U.S. and Vietnam to assess the utility and acceptability of a multi-level pregnancy test (MLPT) for home monitoring of hCG trends after assisted reproduction. BMC Womens Health. 2017 Aug 22;17(1):67. doi: 10.1186/s12905-017-0422-y. |
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| Acceptability of semi-quantitative pregnancy test | Acceptability of using semi-quantitative pregnancy at home instead of tests standard clinic-based monitoring after embryo transfer or IUI. Forms given to document their results at home will include questions on acceptability. Exit interview will also include questions regarding acceptability. | 6 weeks |
| Effectiveness of written instructions and provider's counseling | 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. Forms given to document their results at home will include questions on whether the oral and written instructions helped interpret the results. Exit interview will be conducted to determine how the additional information made the participant feel about conducting the test (i.e. more relaxed, less relaxed, or no difference). | 6 weeks |