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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01846403
First received: May 1, 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, 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.


Condition Intervention
Embryo Transfer
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 the Semi-quantitative Pregnancy Test to Replace Sequential Serum hCG Testing in an Assisted Fertility Setting

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Document whether continuing pregnancy can be successfully monitored at home using a semi-quantitative pregnancy test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Women's acceptability of using pregnancy tests at home instead of standard clinic-based monitoring after embryo transfer [ 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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Semi-quantitative pregnancy test
Semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit)
Device: Semi-quantitative urine pregnancy test
Other Name: (dBest One Step hCG Panel Test Kit)

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01846403

Locations
Vietnam
Hungvuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
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: Tara Shochet, PhD, MPH Gynuity Health Projects
Principal Investigator: Paul Blumenthal, MD, MPH Stanford University
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01846403     History of Changes
Other Study ID Numbers: 6002
Study First Received: May 1, 2013
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration
Vietnam: Hung Vong Hospital

ClinicalTrials.gov processed this record on July 20, 2014