A Bedside Test to Detect the Presence of Embryonic or Fetal Tissue in Vaginal Blood.

OBJECTIVE: To evaluate a rapid bedside test that detects alpha-fetoprotein (AFP) and insulin-like growth factor-binding protein 1 (IGFBP-1) to identify the presence of embryonic or fetal tissue in vaginal blood. METHOD: This was a prospective cohort study. Reproductive-aged individuals were recruited into three groups: a negative control group consisting of nonpregnant individuals undergoing dilation and curettage (D&C) or experiencing vaginal bleeding; a positive control group of individuals with confirmed intrauterine pregnancy undergoing D&C; and the study group of pregnant individuals with first-trimester bleeding. Lateral flow immunoassay strips capable of detecting both AFP and IGFBP-1 were used to test vaginal blood for the presence of embryonic or fetal tissue. RESULTS: Ninety individuals were recruited: 31 in the positive control group, 23 in the negative control group, and 36 in the study group, including 12 individuals with ectopic pregnancies, 16 with active miscarriages, four with threatened miscarriages, and four with complete miscarriages. Vaginal blood from 14 of the 16 individuals with active miscarriages was correctly positive for embryonic or fetal tissue. Vaginal blood from all individuals with ectopic pregnancies, threatened miscarriages, and complete miscarriages was negative for embryonic or fetal tissue. Overall, 45 of 47 individuals with confirmed embryonic or fetal tissue in vaginal blood correctly tested positive using the test strips, a test sensitivity of 95.7% (95% CI 85.5-99.5%). Of the 43 individuals with confirmed absence of embryonic or fetal tissue in their vaginal blood, 42 were correctly negative, a test specificity of 97.7% (95% CI 87.7-99.9%). CONCLUSION: A rapid test strip detecting both AFP and IGFBP-1 can accurately identify the presence of embryonic or fetal tissue in vaginal blood. When positive, this could aid in diagnosing miscarriage and ruling out ectopic pregnancy at the bedside.

IVF and other ART in low- and middle-income countries: a systematic landscape analysis.

BACKGROUND: Infertility affects 48.5 million couples worldwide with a prevalence estimated at 3.5-16.7% in low- and middle-income countries (LMIC), and as high as 30-40% in Sub-Saharan Africa. ART services are not accessible to the majority of these infertile couples due to the high cost of treatments in addition to cultural, religious and legal barriers. Infertility and childlessness, particularly in LMIC, have devastating consequences, which has resulted in considerable interest in developing affordable IVF procedures. However, there is a paucity of evidence on the safety, efficiency and ability to replicate techniques under different field conditions, and how to integrate more affordable ART options into existing infrastructures. OBJECTIVE AND RATIONALE: This review was performed to investigate the current availability of IVF in LMIC and which other ART options are under development. This work will unfold the landscape of available and potential ART services in LMIC and is a key element in positioning infertility more broadly in the Global Public Health Agenda. SEARCH METHODS: A systematic literature search was performed of articles and gray literature on IVF and other ART options in LMIC published between January 2010 and January 2020. We selected studies on IVF and other ART treatments for infertile couples of reproductive age (18-44 years) from LMIC. The review was limited to articles published after 2010, based on the recent evolution in the field of ART practices in LMIC over the last decade. Citations from high-income countries, including data prior to 2010 and focusing on specialized ART procedures, were excluded. The literature search included PubMed, Popline, CINHAL, EMBASE and Global Index Medicus. No restrictions were applied with regard to study design or language. Two reviewers independently screened the titles and abstracts, and extracted data. A search for gray literature was performed using the 'Google' search engine and specific databases (worldcat.org, greylit.org). In addition, the reference lists of included studies were assessed. OUTCOMES: The search of the electronic databases yielded 3769 citations. After review of the titles and abstracts, 283 studies were included. The full texts were reviewed and a further 199 articles were excluded. The gray literature search yielded 586 citations, most of which were excluded after screening the title, and the remaining documents were excluded after full-text assessment due to duplicate entries, not from LMIC, not relevant or no access to the full document. Eighty-four citations were included as part of the review and separated into regions. The majority of the studies were observational and qualitative studies. In general, ART services are available and described in several LMIC, ranging from advanced techniques in China to basic introduction of IVF in some African countries. Efforts to provide affordable ART treatments are described in feasibility studies and efficacy studies; however, most citations were of low to very low quality. We found no studies from LMIC reporting the implementation of low-cost ART that is effective, accessible and affordable to most of those in need of the services. WIDER IMPLICATIONS: The World Health Organization is in a unique position to provide much needed guidance for infertility management in LMIC. This review provides insight into the landscape of ART in LMIC in various regions worldwide, which will guide efforts to improve the availability, quality, accessibility and acceptability of biomedical infertility care, including ART in these countries.