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

Trial ID or NCT#

NCT01919502

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - 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
Exclusion Criteria:
  1. - 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

Investigator(s)

Paul D. Blumenthal, MD, MPH
Paul D. Blumenthal, MD, MPH
Obstetrician and Gynecologist (OB-GYN), Family planning specialist
Professor of Obstetrics and Gynecology (Gynecology-Family Planning) at the Stanford University Medical Center, Emeritus