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

Feasibility and Acceptability of Using a 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 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.

Study Overview

• Status: Completed
• Conditions: Embryo Transfer; Intrauterine Insemination (IUI)
• Intervention / Treatment: Device: Semi-quantitative urine pregnancy test

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Semi-quantitative urine pregnancy test; Semi-quantitative urine pregnancy test (Quanti5 Multilevel hCG Pregnancy Test)	Device: Semi-quantitative urine pregnancy test; Other Names: Quanti5 Multilevel hCG Pregnancy Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of SQPT results that accurately monitor pregnancy	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of women using this test at home	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.	6 weeks
Acceptability of semi-quantitative pregnancy test	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.	6 weeks
Effectiveness of written instructions and provider's counseling	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).	6 weeks

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: 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

Publications and helpful links

General Publications

• Shochet T, Comstock IA, Ngoc NTN, Westphal LM, Sheldon WR, Loc LT, Blum J, Winikoff B, Blumenthal PD. Results of a pilot study in the U.S. and Vietnam to assess the utility and acceptability of a multi-level pregnancy test (MLPT) for home monitoring of hCG trends after assisted reproduction. BMC Womens Health. 2017 Aug 22;17(1):67. doi: 10.1186/s12905-017-0422-y.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 6004