Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test in an Assisted Fertility Setting

Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test to Replace Sequential Serum hCG Testing in an Assisted Fertility Setting

Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, we 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, 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 dBest® semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on a weekly basis for up to 4 weeks after embryo transfer.

We 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. Furthermore, a pregnancy can be assured only when a yolksac or embryo could be identified thus women have to wait for a period of 2-3 weeks after the next menses expected.

We hypothesize that women seeking assisted fertility treatments will be able to monitor their hCG at home as well. Further, we plan to develop revised instructions to better suit the needs and questions we think would be relevant to women desiring to use this test as part of assisted fertility services.

We hypothesize that the simple instructions we will develop for use in this study will enable women to use the test on their own. Provider counseling will complement these instructions and contribute to overall quality of care given to each participant.

Study Overview

• Status: Completed
• Conditions: Embryo Transfer
• Intervention / Treatment: Device: Semi-quantitative urine pregnancy test

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Hungvuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Eligible for assisted fertility treatment according to hospital guidelines
• Agrees to have blood drawn several times for serum hCG tests
• Agrees to return for a series of follow-up visits
• Willing to follow provider instructions regarding use of at-home pregnancy test
• 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:

• Women not eligible for assisted fertility treatment
• Women who do not agree to have blood drawn several times for serum hCG tests
• Women who do not agree return for a series of follow-up visits
• Women unable to follow provider instructions regarding use of at-home pregnancy test
• Women unable to provide contact information
• Women unable to sign the consent form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Semi-quantitative pregnancy test; Semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit)	Device: Semi-quantitative urine pregnancy test; Other Names: (dBest One Step hCG Panel Test Kit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Document whether continuing pregnancy can be successfully monitored at home using a semi-quantitative pregnancy test	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	6 weeks
Women's acceptability of using pregnancy tests at home instead of standard clinic-based monitoring after embryo transfer	6 weeks
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	6 weeks

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Nguyen Thi Nhu Ngoc, MD, Center for Research and Consultancy in Reproductive Health; Principal Investigator: Ly Thai Loc, MD, Hungvuong Hospital; Principal Investigator: Paul Blumenthal, MD, MPH, Stanford University

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: June 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: May 1, 2013
• First Submitted That Met QC Criteria: May 1, 2013
• First Posted (ESTIMATE): May 3, 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: 6002