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目的 探讨D5囊胚培养液中微量β-人绒毛膜促性腺激素(β-hCG)快速检测新方法对囊胚发育潜能及妊娠结局的辅助预测价值。方法 收集体外受精-胚胎移植/单精子卵胞浆注射(IVF/ICSI)助孕患者的D5单囊胚培养液，采用双抗体夹心荧光免疫层析技术快速检测β-hCG水平；按单囊胚移植后妊娠结局分为妊娠组(n=68)与非妊娠组(n=70)，行多因素Logistic回归与受试者工作特征曲线(ROC)曲线分析。结果 该研究临床妊娠率为49.28%，妊娠组女方年龄显著低于非妊娠组，扳机日内膜厚度、扳机日雌二醇(E2)水平、囊胚培养液中β-hCG浓度均高于非妊娠组(P<0.05)。多因素Logistic回归分析显示，囊胚培养液中β-hCG浓度是影响妊娠结局的重要因素。ROC曲线分析显示，当β-hCG浓度截断值为1.460 mIU/mL时，其预测妊娠的特异度达94.3%，灵敏度为42.6%，ROC 曲线下面积(AUC)为0.692。结论 囊胚培养液β-hCG水平与妊娠结局存在关联，具备快速临床诊断及一定的预测参考价值，可为无创评估囊胚发育潜能提供新方法，助力提升囊胚移植成功率。
Abstract：Objective To establish a novel rapid detection method for trace β-human chorionic gonadotrophin (β-hCG) in D5 blastocyst culture medium and to investigate its predictive value for blastocyst developmental potential and pregnancy outcomes. Methods D5 culture medium from single blastocysts of In Vitro Fertilisation – Embryo Transfer/Intracytoplasmic Sperm Injection (IVF/ICSI) patients was collected and subjected to rapid β-hCG level detection using a double-antibody sandwich immunochromatographic assay. Subjects were divided into pregnancy (n=68) and non-pregnancy (n=70) groups based on pregnancy outcomes following single blastocyst transfer. Multivariate logistic regression and receiver operating characteristic (ROC) curve analysis were performed. Results The pregnancy rate was 49.28%. Women in the pregnancy group were significantly younger than those in the non-pregnancy group. Endometrial thickness on the trigger day， estradiol(E2) levels on the trigger day， and β-hCG concentration in blastocyst culture medium were all significantly higher in the pregnancy group (P<0.05). Multivariate logistic regression analysis confirmed that the concentration of β-hCG in the blastocyst culture medium is a significant factor influencing pregnancy outcomes. ROC curve analysis showed that when the cut-off value for β-hCG concentration was set at 1.460 mIU/mL， the specificity for predicting pregnancy was 94.3%， the sensitivity was 42.6%， and the AUC was 0.692. Conclusion β-hCG levels in blastocyst culture medium are associated with pregnancy outcomes; they offer rapid clinical diagnosis and have some predictive value， providing a new method for the non-invasive assessment of blastocyst developmental potential and helping to improve the success rate of blastocyst transfer.
[1] 吴晶晶， 王 超， 徐文娟， 等. IVF/ICSI失败患者再次治疗时不同促排方案的临床分析[J]. 安徽医科大学学报， 2020， 55(10): 1571-4. doi:10.19405/j.cnki.issn1000-1492.2020.10.018.
[2] Tesarik J. Noninvasive biomarkers of human embryo developmental potential[J]. Int J Mol Sci， 2025， 26(10): 4928. doi:10.3390/ijms26104928.
[3] Ryu J S， Yang N R， Shim Y H， et al. The role of β-core fragment hCG in embryo implantation and early pregnancy[J]. Int J Mol Sci， 2025， 26(16): 7974. doi:10.3390/ijms26167974.
[4] 张会娜， 李学伟， 王 涛， 等. 不同形态及发育结局D3胚胎培养液中HCG水平比较[J]. 生殖医学杂志， 2023， 32(6): 933-7. doi:10.3969/j.issn.1004-3845.2023.06.021.
[5] Fujiuchi K， Aoki N， Ohtake T， et al. Transitions in immunoassay leading to next-generation lateral flow assays and future prospects[J]. Biomedicines， 2024， 12(10): 2268. doi:10.3390/biomedicines12102268.
[6] Kathiresan A S Q， Cruz-Almeida Y， Barrionuevo M J， et al. Prognostic value of beta-human chorionic gonadotropin is dependent on day of embryo transfer during in vitro fertilization[J]. Fertil Steril， 2011， 96(6): 1362-6. doi:10.1016/j.fertnstert.2011.09.042.
[7] Sacchi L， Albani E， Cesana A， et al. Preimplantation genetic testing for aneuploidy improves clinical， gestational， and neonatal outcomes in advanced maternal age patients without compromising cumulative live-birth rate[J]. J Assist Reprod Genet， 2019， 36(12): 2493-504. doi:10.1007/s10815-019-01609-4.
[8] Luo S， Li X， Wang Y， et al. Effect of preimplantation genetic testing for aneuploidies on live birth outcomes and the influencing factors in women of advanced maternal age[J]. Sichuan Da Xue Xue Bao Yi Xue Ban， 2024， 55(5): 1288-94. doi:10.12182/20240960208.
[9] Zhu W， Yeung Q， Chan D， et al. Maternal β-HCG concentrations in early IVF pregnancy: association with the embryo development stage of blastocysts[J]. Reprod BioMedicine Online， 2019， 38(5): 683-90. doi:10.1016/j.rbmo.2018.11.035.
[10] Butler S A， Luttoo J， Freire M O T， et al. Human chorionic gonadotropin (hCG) in the secretome of cultured embryos: hyperglycosylated hCG and hCG-Free beta subunit are potential markers for infertility management and treatment[J]. Reprod Sci， 2013， 20(9): 1038-45. doi:10.1177/1933719112472739.
[11] Goumenou A， Chendo C， Combès A， et al. Characterization of Concanavalin A-based lectin sorbents for the extraction of the human chorionic gonadotropin glycoforms prior to analysis by nano liquid chromatography-high resolution mass spectrometry[J]. J Pharm Biomed Anal， 2024， 242: 116022. doi:10.1016/j.jpba.2024.116022.
[12] Chen C Y， Hwu Y M， Weng Y W， et al. Clinical application of immunomagnetic reduction for quantitative analysis of beta-subunit of human chorionic gonadotropin in blastocyst culture media to differentiate embryo quality[J]. Clin Chim Acta， 2019， 491: 46-51. doi:10.1016/j.cca.2019.01.012.
[13] Li N， Zhang Y， Li R， et al. Personalized embryo transfer guided by rsERT improves pregnancy outcomes in patients with repeated implantation failure[J]. Front Med， 2024， 11: 1369317. doi:10.3389/fmed.2024.1369317.
[14] Rai A， Poh Q H， Okae H， et al. Dynamic proteome landscape during preimplantation human embryo development and trophectoderm stem cell-differentiation[J]. PROTEOMICS， 2025， 25(15): 72-89. doi:10.1002/pmic.70017.
基本信息:
中图分类号:R714.8
引用信息:
[1]郑红玉,郝燕,张清,等.囊胚培养液中微量β-hCG快速检测方法的建立及其胚胎潜能评估的初步研究[J].安徽医科大学学报().
基金信息:
国家自然科学基金项目（编号：U24A20764）
2026-08-25
2026-08-25
2026-08-25