Clinical trialNCT01919502CompletedInterventional

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

SponsorGynuity Health ProjectsEnrollment51Embryo TransferIntrauterine Insemination (IUI)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Beverly Winikoff, MD, MPH
Gynuity Health Projects
Principal Investigator
clinicaltrials.gov ↗
Lynn Westphal, MD
Division of Reproductive Endocrinology and Infertility Stanford University School of Medicine
Principal Investigator
clinicaltrials.gov ↗
Paul Blumenthal, MD, MPH
Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of Medicine
Principal Investigator
clinicaltrials.gov ↗
Wendy Sheldon, MPH, MSW, PhD
Gynuity Health Projects
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Stanford University Medical Center
Palo Alto, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2013
Primary completion: 30 Apr 2014
Completion: 30 Apr 2014
Last update posted: 14 May 2014
Registered enrollment: 51
Registry id: NCT01919502

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.