PDF(Pubmed)
Abstract：
OBJECTIVE: This study evaluates the efficacy of intrauterine hCG perfusion for RIF, as defined by ESHRE 2023 guidelines, highlighting hCG as a cost-effective alternative to other immunotherapies, especially suitable for less developed regions. It aims to clarify treatment guidance amidst previous inconsistencies.
METHODS: This meta-analysis, registered with PROSPERO (CRD42024443241) and adhering to PRISMA guidelines, assessed the efficacy and safety of intrauterine hCG perfusion in enhancing implantation and pregnancy outcomes in RIF. Comprehensive literature searches were conducted through December 2023 in major databases including PubMed, Web of Science, Embase, the Cochrane Library, and key Chinese databases, without language restrictions. Inclusion and exclusion criteria were strictly aligned with the 2023 ESHRE recommendations, with exclusions for studies lacking robust control, clear outcomes, or adequate data integrity. The risk of bias was evaluated using the Newcastle-Ottawa Scale, ROBINS-I, and RoB2 tools. Data analysis was performed in R using the \'meta\' package, employing both fixed and random effect models to account for study variability. Subgroup analyses by dosage, volume, hCG concentration, timing of administration, and type of embryo transfer were conducted to deepen insights, enhancing the reliability and depth of the meta-analysis in elucidating the role of hCG perfusion in RIF treatments.
RESULTS: Data from 13 studies, comprising six retrospective and six prospective studies from single centers, along with one multi-center RCT, totaling 2,157 participants, were synthesized to evaluate the effectiveness of intrauterine hCG perfusion in enhancing implantation and pregnancy outcomes in patients with RIF. Significant improvements were observed in clinical pregnancy and embryo implantation rates across various dosages, timing of administration, and embryo developmental stages, without impacting miscarriage rates. Notably, the most significant efficacy within subgroups occurred with a 500 IU dosage and perfusion parameters of ≤ 500µL volume and ≥ 2 IU/µL concentration. Additionally, a limited number of studies showed no significant increases in ectopic pregnancy or multiple pregnancy rates, and a modest improvement in live birth rates, although the small number of these studies precludes definitive conclusions.
CONCLUSIONS: The analysis suggests that intrauterine hCG perfusion probably enhances embryo implantation, clinical pregnancy, and live birth rates slightly in RIF patients. Benefits are indicated with a dosage of 500 IU and a maximum volume of 500µL at concentrations of at least 2 IU/µL. However, substantial heterogeneity from varying study types and the limited number of studies necessitate cautious interpretation. These findings underscore the need for more rigorously designed RCTs to definitively assess the efficacy and safety.
METHODS: This meta-analysis, registered with PROSPERO (CRD42024443241) and adhering to PRISMA guidelines, assessed the efficacy and safety of intrauterine hCG perfusion in enhancing implantation and pregnancy outcomes in RIF. Comprehensive literature searches were conducted through December 2023 in major databases including PubMed, Web of Science, Embase, the Cochrane Library, and key Chinese databases, without language restrictions. Inclusion and exclusion criteria were strictly aligned with the 2023 ESHRE recommendations, with exclusions for studies lacking robust control, clear outcomes, or adequate data integrity. The risk of bias was evaluated using the Newcastle-Ottawa Scale, ROBINS-I, and RoB2 tools. Data analysis was performed in R using the \'meta\' package, employing both fixed and random effect models to account for study variability. Subgroup analyses by dosage, volume, hCG concentration, timing of administration, and type of embryo transfer were conducted to deepen insights, enhancing the reliability and depth of the meta-analysis in elucidating the role of hCG perfusion in RIF treatments.
RESULTS: Data from 13 studies, comprising six retrospective and six prospective studies from single centers, along with one multi-center RCT, totaling 2,157 participants, were synthesized to evaluate the effectiveness of intrauterine hCG perfusion in enhancing implantation and pregnancy outcomes in patients with RIF. Significant improvements were observed in clinical pregnancy and embryo implantation rates across various dosages, timing of administration, and embryo developmental stages, without impacting miscarriage rates. Notably, the most significant efficacy within subgroups occurred with a 500 IU dosage and perfusion parameters of ≤ 500µL volume and ≥ 2 IU/µL concentration. Additionally, a limited number of studies showed no significant increases in ectopic pregnancy or multiple pregnancy rates, and a modest improvement in live birth rates, although the small number of these studies precludes definitive conclusions.
CONCLUSIONS: The analysis suggests that intrauterine hCG perfusion probably enhances embryo implantation, clinical pregnancy, and live birth rates slightly in RIF patients. Benefits are indicated with a dosage of 500 IU and a maximum volume of 500µL at concentrations of at least 2 IU/µL. However, substantial heterogeneity from varying study types and the limited number of studies necessitate cautious interpretation. These findings underscore the need for more rigorously designed RCTs to definitively assess the efficacy and safety.
摘要：
目的：本研究评估宫内hCG灌注对RIF的疗效，根据ESHRE2023指南的定义，强调hCG是其他免疫疗法的一种具有成本效益的替代品，特别适用于欠发达地区。它旨在澄清以前不一致的治疗指导。
方法：本荟萃分析，在PROSPERO（CRD42024443241）注册并遵守PRISMA指南，评估了宫内hCG灌注增强RIF植入和妊娠结局的有效性和安全性。到2023年12月，在包括PubMed在内的主要数据库中进行了全面的文献检索，WebofScience,Embase,Cochrane图书馆,和关键的中文数据库，没有语言限制。纳入和排除标准与2023年ESHRE建议严格保持一致，排除缺乏鲁棒控制的研究，明确的结果，或足够的数据完整性。使用纽卡斯尔-渥太华量表评估偏倚风险，Robins-I,RoB2工具在R中使用\'meta\'包进行数据分析，采用固定和随机效应模型来解释研究的变异性。按剂量分组分析，volume,hCG浓度,管理的时机,和胚胎移植的类型进行了深化的见解，增强meta分析在阐明hCG灌注在RIF治疗中的作用方面的可靠性和深度。
结果：来自13项研究的数据，包括来自单一中心的六项回顾性研究和六项前瞻性研究，还有一个多中心RCT，共2157人,综合评价宫内hCG灌注对RIF患者植入和妊娠结局的影响。不同剂量的临床妊娠率和胚胎着床率均有显著改善，管理的时机,和胚胎发育阶段，不影响流产率。值得注意的是,亚组中最显著的疗效发生在500IU剂量和灌注参数≤500µL体积和≥2IU/µL浓度.此外,数量有限的研究表明，异位妊娠或多胎妊娠率没有显着增加，活产率的适度改善，尽管这些研究的数量很少，但无法得出明确的结论。
结论：分析表明，宫内hCG灌注可能会促进胚胎植入，临床妊娠,RIF患者的活产率略有下降。剂量为500IU，最大体积为500µL，浓度至少为2IU/µL。然而,不同研究类型的实质性异质性和有限的研究数量需要谨慎的解释。这些发现强调了需要更严格设计的RCT来明确评估疗效和安全性。
方法：本荟萃分析，在PROSPERO（CRD42024443241）注册并遵守PRISMA指南，评估了宫内hCG灌注增强RIF植入和妊娠结局的有效性和安全性。到2023年12月，在包括PubMed在内的主要数据库中进行了全面的文献检索，WebofScience,Embase,Cochrane图书馆,和关键的中文数据库，没有语言限制。纳入和排除标准与2023年ESHRE建议严格保持一致，排除缺乏鲁棒控制的研究，明确的结果，或足够的数据完整性。使用纽卡斯尔-渥太华量表评估偏倚风险，Robins-I,RoB2工具在R中使用\'meta\'包进行数据分析，采用固定和随机效应模型来解释研究的变异性。按剂量分组分析，volume,hCG浓度,管理的时机,和胚胎移植的类型进行了深化的见解，增强meta分析在阐明hCG灌注在RIF治疗中的作用方面的可靠性和深度。
结果：来自13项研究的数据，包括来自单一中心的六项回顾性研究和六项前瞻性研究，还有一个多中心RCT，共2157人,综合评价宫内hCG灌注对RIF患者植入和妊娠结局的影响。不同剂量的临床妊娠率和胚胎着床率均有显著改善，管理的时机,和胚胎发育阶段，不影响流产率。值得注意的是,亚组中最显著的疗效发生在500IU剂量和灌注参数≤500µL体积和≥2IU/µL浓度.此外,数量有限的研究表明，异位妊娠或多胎妊娠率没有显着增加，活产率的适度改善，尽管这些研究的数量很少，但无法得出明确的结论。
结论：分析表明，宫内hCG灌注可能会促进胚胎植入，临床妊娠,RIF患者的活产率略有下降。剂量为500IU，最大体积为500µL，浓度至少为2IU/µL。然而,不同研究类型的实质性异质性和有限的研究数量需要谨慎的解释。这些发现强调了需要更严格设计的RCT来明确评估疗效和安全性。
