Embryo Transfer, Intrauterine Insemination (IUI)
Conditions
Brief summary
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.
Interventions
Sponsors
Stanford University
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Planning embryo transfer or intrauterine insemination (IUI) * Agrees to return for a series of follow-up visits * Willing to follow provider instructions regarding use of at-home pregnancy test * Has not already participated in this study (each woman can only participate once) * Able to read and write in English * Willing to provide an address and/or telephone number to be contacted for purposes of follow-up * Willing and able to consent to study participation
Exclusion criteria
* Does not agree to return for a series of follow-up visits * Not willing to follow provider instructions regarding use of at-home pregnancy test * Has already participated in this study (each woman can only participate once) * Not able to read and write in English * Not willing to provide an address and/or telephone number to be contacted for purposes of follow-up * Not willing and able to consent to study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of SQPT results that accurately monitor pregnancy | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of women using this test at home | 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 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 | 6 weeks | 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 | 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. 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). |
Countries
United States
Outcome results
None listed