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Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment

NCT01919502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-05-14

No results posted yet for this 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.

Conditions

  • Embryo Transfer
  • Intrauterine Insemination (IUI)

Interventions

DEVICE

Semi-quantitative urine pregnancy test

Sponsors & Collaborators

Principal Investigators

  • Lynn Westphal, MD · Division of Reproductive Endocrinology and Infertility Stanford University School of Medicine

  • Paul Blumenthal, MD, MPH · Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of Medicine

  • Wendy Sheldon, MPH, MSW, PhD · Gynuity Health Projects

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01919502 on ClinicalTrials.gov