Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
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|ClinicalTrials.gov Identifier: NCT01919502|
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : May 14, 2014
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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.
|Condition or disease||Intervention/treatment||Phase|
|Embryo Transfer Intrauterine Insemination (IUI)||Device: Semi-quantitative urine pregnancy test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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
- Proportion of SQPT results that accurately monitor pregnancy [ Time Frame: 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.
- Feasibility of women using this test at home [ 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 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 ]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 ]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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
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): NCT01919502
|United States, California|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94305|
|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|
|Responsible Party:||Gynuity Health Projects|
|Other Study ID Numbers:||
|First Posted:||August 9, 2013 Key Record Dates|
|Last Update Posted:||May 14, 2014|
|Last Verified:||May 2014|