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

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).

The Ability of Quantitative, Specific, and Sensitive Point-of-Care/Chair-Side Oral Fluid Immunotests for aMMP-8 to Detect Periodontal and Peri-Implant Diseases

“…The tests, PerioSafe and ImplantSafe, and reader (ORALyser) have been developed and manufactured by Medix Biochemica Ltd (Espoo, Finland) and dentognostics GmbH (Jena, Germany) and are commercially available from Dentognostics GmbH (Jena, Germany). In fact, the PoC/chair-side aMMP-8 lateral-flow immunotests resemble the classical pregnancy and/or recently described HIV-PoC tests [ 16 , 17 ]. The aMMP-8 oral fluid tests can be used according to the manufacturer's instructions [ 5 ].…”

Self-testing for pregnancy: a systematic review and meta-analysis

“… 6 Home pregnancy tests have been shown to be an acceptable and feasible option for follow-up among couples undergoing assisted reproduction. 7 There is also evidence supporting the efficacy, safety and acceptability of urine pregnancy tests to confirm the effectiveness of a medical abortion instead of an ultrasound. 8 9 While urine pregnancy self-tests are available over-the-counter in many high-income and middle-income settings, in many low-income settings, they may be financially inaccessible to most people outside of public health services, or unavailable altogether, leading individuals with the sole option of health facility-based blood tests to confirm pregnancy.…”

“…In Madagascar, randomised trial data have shown that providing pregnancy tests to community health workers (CHWs) for home distribution can increase both engagement in antenatal care services5 and contraceptive services, since a negative pregnancy test is necessary before initiating some contraceptive methods 6. Home pregnancy tests have been shown to be an acceptable and feasible option for follow-up among couples undergoing assisted reproduction 7. There is also evidence supporting the efficacy, safety and acceptability of urine pregnancy tests to confirm the effectiveness of a medical abortion instead of an ultrasound 8 9.…”

Self-Monitoring of Urinary Hormones in Combination with Telemedicine — a Timely Review and Opinion Piece in Medically Assisted Reproduction

“…Hormone monitoring is also used during early pregnancy to assess the developing fetus, offering the opportunity to intervene and prevent miscarriage [ 1 , 3 , 20 , 90 , 91 ], and could be of benefit to other areas of reproductive health. A pilot study assessed the use of a multi-level pregnancy test based on self-monitoring of urinary hCG trends after assisted reproduction [ 92 ]. The results found that 73% of women reported being ‘satisfied’ or ‘very satisfied’ with the home tests and 96.6% found it ‘easy’ or ‘very easy’ to use, and home test results were generally consistent with the results of clinic-based serum hCG testing [ 92 ].…”

“…A pilot study assessed the use of a multi-level pregnancy test based on self-monitoring of urinary hCG trends after assisted reproduction [ 92 ]. The results found that 73% of women reported being ‘satisfied’ or ‘very satisfied’ with the home tests and 96.6% found it ‘easy’ or ‘very easy’ to use, and home test results were generally consistent with the results of clinic-based serum hCG testing [ 92 ]. Urinary hormone profiling has shown promise for studying corpus luteum deficiency, which may occur during early pregnancy as a result of insufficient progesterone levels.…”