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

This study has been completed.
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01919502
First received: August 5, 2013
Last updated: May 12, 2014
Last verified: May 2014
  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.


Condition Intervention
Embryo Transfer
Intrauterine Insemination (IUI)
Device: Semi-quantitative urine pregnancy test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Proportion of SQPT results that accurately monitor pregnancy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Participants will have follow-up visits that include serum hCG testing and ultrasounds to confirm pregnancy. Will be able to compare these results to the results of the at-home pregnancy test.


Secondary Outcome Measures:
  • Feasibility of women using this test at home [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Feasibility of women using this test at home on their own as a potential future substitute or complement to standard sequential clinic-based visits to monitor pregnancy after embryo transfer or IUI. Forms given to document their results at home will include questions on feasibility. Exit interview will also include questions regarding feasibility.

  • Acceptability of semi-quantitative pregnancy test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Acceptability of using semi-quantitative pregnancy at home instead of tests standard clinic-based monitoring after embryo transfer or IUI. Forms given to document their results at home will include questions on acceptability. Exit interview will also include questions regarding acceptability.

  • Effectiveness of written instructions and provider's counseling [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Assess if written instructions and provider's counseling enable women using the semi-quantitative pregnancy test at home to understand how it should be used and to correctly interpret the test result. Forms given to document their results at home will include questions on whether the oral and written instructions helped interpret the results. Exit interview will be conducted to determine how the additional information made the participant feel about conducting the test (i.e. more relaxed, less relaxed, or no difference).


Enrollment: 51
Study Start Date: October 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Semi-quantitative urine pregnancy test
Semi-quantitative urine pregnancy test (Quanti5 Multilevel hCG Pregnancy Test)
Device: Semi-quantitative urine pregnancy test
Other Name: Quanti5 Multilevel hCG Pregnancy Test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919502

Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Gynuity Health Projects
Stanford University
Investigators
Principal Investigator: Lynn Westphal, MD Division of Reproductive Endocrinology and Infertility Stanford University School of Medicine
Principal Investigator: Paul Blumenthal, MD, MPH Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of Medicine
Principal Investigator: Wendy Sheldon, MPH, MSW, PhD Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01919502     History of Changes
Other Study ID Numbers: 6004
Study First Received: August 5, 2013
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014