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

Abstract

Background: To evaluate the utility and acceptability of using multi-level pregnancy tests (MLPTs) at home to monitor hCG trends following assisted reproductive technology (ART).

Methods: One 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.

Results: Data 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.

Conclusion: The MLPT offers women and health care providers a client-friendly diagnostic tool to detect very early pregnancy and monitor its progress.

Trial registration: This study was registered on clinicaltrials.gov as NCT01846403 (May 1, 2013), and NCT01919502 (August 5, 2013).

Keywords: Assisted fertility; Multi-level pregnancy test; Semi-quantitative pregnancy test; hCG.

Conflict of interest statement

Ethics approval and consent to participate

This study received ethical approval by Stanford’s Institutional Review Board and Hung Vuong Hospital’s Ethical and Scientific Committee. All participants provided written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors confirm that they have no competing interests to disclose.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The dBest® multi-level pregnancy test with reading of at least 25 mIU/mL of hCG

References

    1. Sullivan EA, Zegers-Hochschild F, Mansour R, Ishihara O, de Mouzon J, Nygren KG, Adamson GD. International Committee for Monitoring Assisted Reproductive Technologies (ICMART) world report: assisted reproductive technology 2004. Hum Reprod. 2013;28:1375–1390. doi: 10.1093/humrep/det036.
    1. Hovatta O, Cooke I. Cost-effect approaches to in vitro fertilization: means to improve access. IJGO. 2006;94:287–297.
    1. Blum J, Shochet T, Lynd K, Lichtenberg ES, Fischer D, Arnesen M, Winikoff B, Blumenthal PD. Can at-home semi-quantitative pregnancy tests serve as a replacement for clinical follow-up of medical abortion: A United States study. Contraception. 2012;86(6):757–762. doi: 10.1016/j.contraception.2012.06.005.
    1. Lynd K, Blum J, Ngoc NT, Shochet T, Blumenthal PD, Winikoff B. Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up. Int J Gynecol Obstet. 2013;121(2):144–148. doi: 10.1016/j.ijgo.2012.11.022.
    1. Ngoc NT, Bracken H, Blum J, Nga NT, Minh NH, van Nhang N, Lynd K, Winikoff B, Blumenthal PD. Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: a randomized controlled trial. Obstet Gynecol. 2014;123(1):88–95. doi: 10.1097/AOG.0000000000000050.
    1. Platais I, Tsereteli T, Comendant R, Kurbanbekova D, Winikoff B. Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan. Contraception. 2015;91(2):178–183. doi: 10.1016/j.contraception.2014.11.004.
    1. Grossman D, Berdichevsky K, Larrea F, Beltran J. Accuracy of a semi-quantitative urine pregnancy test compared to serum beta-hCG measurement: a possible screening tool for ongoing pregnancy after medical abortion. Contraception. 2007;76:101–104. doi: 10.1016/j.contraception.2007.04.008.
    1. Holter H, Sandin-Bojö AK, Gejervall AL, Wikland M, Wilde-Larsson B, Bergh C. Patient-centered quality of care in an IVF programme evaluated by men and women. Hum Reprod. 2014;29(12):2695–2703. doi: 10.1093/humrep/deu254.
    1. Baker V. Mild ovarian stimulation for in vitro fertilization: one perspective from the USA. J Assist Reprod Genet. 2013;30:197–202. doi: 10.1007/s10815-013-9946-8.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren