Trials / Completed
CompletedNCT01919502
Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Gynuity Health Projects · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Semi-quantitative urine pregnancy test |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2013-08-09
- Last updated
- 2014-05-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01919502. Inclusion in this directory is not an endorsement.