Abstract
BACKGROUND: Serum beta-human chorionic gonadotropin (β-hCG) is a prominent indicator of early pregnancy and is crucial for monitoring pregnancies post-in vitro fertilization (IVF). Numerous scholarly investigations had delineated the initial serum β-hCG threshold values using receiver operating characteristic (ROC) curves to distinguish between clinical pregnancy and live birth versus pregnancy failure. However, the variability across these investigations raised concerns about the generalizability of their conclusions to the population undergoing single embryo transfer (SET) within IVF/intracytoplasmic sperm injection (ICSI) cycles. Therefore, this study aimed to critically evaluate the diagnostic accuracy of initial serum β-hCG in predicting clinical pregnancy or live birth outcomes post-SET in IVF/ICSI cycles through a rigorous synthesis of published data. METHODS: A comprehensive literature search was conducted in PubMed, Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), and China Biology Medicine disc databases to identify potentially eligible studies published before December 22, 2023. Studies that adhered to the inclusion and exclusion criteria were incorporated into the meta-analysis without any restrictions based on language. The Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) checklist was utilized to assess the quality of the included studies. Pooled summary estimates, including sensitivity, specificity, and diagnostic odds ratio (DOR), were calculated. Summary receiver operating characteristic curves (SROC) were constructed, and the area under the curve (AUC) was used to evaluate the prognostic performance of initial serum β-hCG on pregnancy outcomes. RESULTS: The quantitative synthesis (meta-analysis) included 12 studies, comprising 10 unique entities examining the use of initial serum β-hCG for predicting clinical pregnancy post-SET in IVF/ICSI cycles and 11 entities investigating the effectiveness of initial serum β-hCG in predicting live birth following SET in the same cycles. Initial serum β-hCG showed reference informative diagnostic performance in predicting clinical pregnancy with a pooled sensitivity and specificity of 0.91 and 0.89, respectively, a DOR of 65.07, and an AUC of 0.95. For live birth prediction, initial serum β-hCG demonstrated a certain degree of diagnostic capability with a pooled sensitivity and specificity of 0.87 and 0.70, a DOR of 15.07, and an AUC of 0.82. CONCLUSIONS: Our research assessed the diagnostic efficacy of initial serum β-hCG for detecting clinical pregnancy and live birth through a meta-analysis of data from 12 published studies. This study suggested that the initial serum β-hCG levels had a certain predictive value for pregnancy outcomes following SET in IVF/ICSI cycles. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42023493086.