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

Tara Shochet,Paul D Blumenthal,Jennifer Blum,Ly Thai Loc,Lynn M Westphal,Wendy R Sheldon,Nguyen Thi Nhu Ngoc,Ioanna A Comstock,Beverly Winikoff

doi:10.1186/s12905-017-0422-y

Abstract

BackgroundTo evaluate the utility and acceptability of using multi-level pregnancy tests (MLPTs) at home to monitor hCG trends following assisted reproductive technology (ART).MethodsOne hundred and four women presenting for ART at either Stanford Medicine Fertility and Reproductive Health Clinic (Stanford, CA) or Hung Vuong Hospital (Ho Chi Minh City, Vietnam) participated in this pilot study. Women were asked to perform the MLPT at home, primarily on days when they were also scheduled to receive standard clinic-based serum hCG testing. These tests were administered up to 6 times over the 6-week period following embryo transfer or intrauterine insemination (IUI). Concordance of serial hCG readings for each time point was assessed by comparing trends in urine MLPT results with trends in serum hCG. Stable or increasing hCG level was interpreted as an indication of a progressing pregnancy, while a declining hCG was interpreted as a lack of established or progressing pregnancy. At study end, all participants were asked about the acceptability and convenience of using the MLPT at home for monitoring hCG trends following ART.ResultsData from both urine and serum testing are available for 156 of 179 clinic visits (87.2%). There was high concordance of serial trend results between the two types of tests: among the 156 sets of serum and urine hCG data points, 150 (96.2%) showed a matching trend in hCG pattern and 6 (3.8%) resulted in a discordant trend. Seventy-three percent of women reported being satisfied or very satisfied with using the MLPTs at home. Almost all (96.6%) said that the MLPT was easy or very easy to use.ConclusionThe MLPT offers women and health care providers a client-friendly diagnostic tool to detect very early pregnancy and monitor its progress.Trial registrationThis study was registered on clinicaltrials.gov as NCT01846403 (May 1, 2013), and NCT01919502 (August 5, 2013).

Highlights

To evaluate the utility and acceptability of using multi-level pregnancy tests (MLPTs) at home to monitor human chorionic gonadotropin (hCG) trends following assisted reproductive technology (ART)
Inclusion criteria were being eligible for the assisted fertility treatment per clinic guidelines, agreeing to a series of blood draws for serum hCG testing, agreeing to return for a series of follow-up visits, willingness to follow provider and written instructions regarding use of the at-home pregnancy test, and willingness to provide contact information for follow-up
42 women (40.4%) exhibited signs of pregnancy including an increase in hCG (≥ 25 mIU/ml) as measured by either MLPT or serum test

Summary

Introduction

To evaluate the utility and acceptability of using multi-level pregnancy tests (MLPTs) at home to monitor hCG trends following assisted reproductive technology (ART). 1.5 million assisted reproductive technology (ART) cycles are performed each year worldwide [1]. Women are expected to comply with numerous clinic visits throughout the process, resulting in time away from employment and/or home [2]. Standard monitoring protocols after embryo transfer include sequential serum hCG analyses and ultrasound – all done on a regular (at times weekly) basis in a clinic or lab setting. Serum hCG requires a blood draw and lab testing. In the best of circumstances, women receive their lab results the afternoon of their serum blood test. Women have already left the clinic before the result is known

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Results

Discussion

Conclusion