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

Summary

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.

Conditions

• Embryo Transfer

Interventions

DEVICE

Semi-quantitative urine pregnancy test

Sponsors & Collaborators

• Gynuity Health Projects

  lead OTHER

Principal Investigators

• Nguyen Thi Nhu Ngoc, MD · Center for Research and Consultancy in Reproductive Health

• Ly Thai Loc, MD · Hungvuong Hospital

• Tara Shochet, PhD, MPH · Gynuity Health Projects

• Paul Blumenthal, MD, MPH · Stanford University

• Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• Vietnam

Study Locations