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.
Intrauterine Insemination (IUI)
Device: Semi-quantitative urine pregnancy test
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment|
- Proportion of SQPT results that accurately monitor pregnancy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
- Feasibility of women using this test at home [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
- Acceptability of semi-quantitative pregnancy test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
- Effectiveness of written instructions and provider's counseling [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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).
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Semi-quantitative urine pregnancy test
Semi-quantitative urine pregnancy test (Quanti5 Multilevel hCG Pregnancy Test)
Device: Semi-quantitative urine pregnancy test
Other Name: Quanti5 Multilevel hCG Pregnancy Test
|Contact: Wendy Sheldon, MPH, MSW, PhDemail@example.com|
|United States, California|
|Stanford University Medical Center||Recruiting|
|Palo Alto, California, United States, 94305|
|Contact: Alma Gonzales, MPH 650-721-1237 firstname.lastname@example.org|
|Principal Investigator:||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|