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NCT01919502 · ClinicalTrials.gov registry record · NA
Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
A NA study, sponsored by Gynuity Health Projects.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT01919502 is a NA study that has completed, run by Gynuity Health Projects. The registered enrollment target is 51 participants.
The verdict
NCT01919502, a NA study, has completed, sponsored by Gynuity Health Projects.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study 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
- DEVICE Semi-quantitative urine pregnancy test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01919502
The ClinicalTrials.gov registry entry for NCT01919502 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gynuity Health Projects, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Semi-quantitative urine pregnancy test is the first listed.
NCT01919502 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01919502 about?
NCT01919502 is a clinical study titled "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...
What is the current status of trial NCT01919502?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2013-10. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01919502?
The interventions under investigation include: Semi-quantitative urine pregnancy test (DEVICE).
Who is sponsoring clinical trial NCT01919502?
This trial is sponsored by Gynuity Health Projects, which has 29 total clinical trials registered on ClinicalTrials.gov.
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