不同时机宫腔镜检查对IVF-ET助孕患者妊娠结局的影响研究

Effect of Different Timing of Hysteroscopy on Pregnancy Outcomes in Patients Undergoing IVF-ET

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目的:探讨不同时机宫腔镜检查对反复胚胎移植未孕患者后续体外受精-胚胎移植(IVF-ET)临床妊娠结局的影响。方法:回顾性分析2025年1月至2025年10月于东莞康华医院生殖医学科就诊的206例行IVF-ET助孕研究对象的临床资料。根据宫腔镜检查时机分为三组:A组(胚胎移植前检查,n=82)、B组(胚胎移植1次失败后检查,n=70)、C组(胚胎移植2次失败后检查,n=54)。比较三组研究对象后续IVF-ET周期的临床妊娠率。结果:三组研究对象基线年龄、不孕年限、BMI、AMH等指标差异无统计学意义(P>0.05)。总人群临床妊娠率为53.59%(97/206),其中A组妊娠率为72.0%(59/82),B组为35.7%(25/70),C组为24.1%(13/54),组间差异有统计学意义(P<0.001)。免疫双染阳性研究对象占86.27%(176/206),其在组间分布均衡,未改变主要结论。结论:对于IVF-ET助孕研究对象,胚胎移植前进行宫腔镜检查并处理异常,可能与后续临床妊娠率升高相关;延迟至1次或2次胚胎移植失败后再检查,妊娠获益可能大幅降低。提示胚胎移植前常规行宫腔镜评估的必要性。
Objective: To investigate the impact of different timing of hysteroscopy on the subsequent clinical pregnancy outcomes of patients with recurrent embryo transfer failure undergoing in vitro fertilization - embryo transfer (IVF-ET). Methods: The clinical data of 206 patients who underwent IVF-ET assisted pregnancy treatment at the Reproductive Medicine Department of Dongguan Kanghua Hospital from January 2025 to October 2025 were retrospectively analyzed. The patients were divided into three groups based on the timing of hysteroscopy: Group A (examined before embryo transfer, n = 82), Group B (examined after one failed embryo transfer, n = 70), and Group C (examined after two failed embryo transfers, n = 54). The clinical pregnancy rates of the subsequent IVF-ET cycles of the three groups were compared. Results: There were no statistically significant differences in baseline age, duration of infertility, BMI, AMH, etc. among the three groups (P > 0.05). The overall clinical pregnancy rate of the population was 53.59% (97/206), with the pregnancy rates in Group A being 72.0% (59/82), in Group B 35.7% (25/70), and in Group C 24.1% (13/54). The differences among the groups were statistically significant (P < 0.001). Immunobright staining positive study subjects accounted for 86.27% (176/206), and their distribution among the groups was balanced, without changing the main conclusion. Conclusion: For patients undergoing IVF-ET assisted pregnancy treatment, performing hysteroscopy and treating abnormalities before embryo transfer may be associated with an increased subsequent clinical pregnancy rate; delaying the examination until one or two failed embryo transfers may significantly reduce the pregnancy benefit. It suggests the necessity of routine hysteroscopy assessment before embryo transfer.
论著

一次性使用电子宫腔镜与可重复使用宫腔镜用于门诊宫腔镜检查的多中心随机对照研究

A multicenter randomized controlled study of single-use digital hysteroscope versus reusable hysteroscope for outpatient hysteroscopy

:16-22
 
目的 比较采用一次性使用电子宫腔镜与可重复使用宫腔镜用于门诊宫腔镜检查的有效性与安全性。方法 采用平行随机对照的方法,在3间临床试验研究机构同时进行,一次性使用电子宫腔镜用于宫腔镜检查者82例为试验组,Storz Bettochi检查镜进行检查者82例为对照组。记录2组患者宫腔影像的临床诊断符合率、操作性能评分、不良事件发生率。结果 试验组临床诊断要求符合率98.8%(80/82),对照组临床诊断要求符合率100%(82/82);试验组与对照组宫腔影像的临床诊断要求符合率的差值为-1.22%,试验组和对照组符合率差值的95%可信区间下限为-3.60%,大于非劣效界值-10.00%。试验组与对照组之间的操作性能评分比较差异无统计学意义(P>0.05)。试验组不良事件发生率11.0%(9例,9件),严重不良事件发生率1.2%(1例,1件);对照组中不良事件发生率9.8%(8例,9件),严重不良事件发生率0%(0例,0件);不良事件发生率和严重不良事件发生率的组间比较差异均无统计学意义(P>0.05)。结论 一次性使用电子宫腔镜用于提供患者子宫内图像,整体性能与可重复使用的电子宫腔镜相当,并且安全性好。试验用一次性使用电子宫腔镜的使用性能可满足临床宫腔镜手术的需求,可作为宫腔镜技术的补充手段。
Objective To compare the efficacy and safety of single-use digital hysteroscope and reusable hysteroscope for outpatient hysteroscopy.Methods A parallel randomized control method was used in three clinical trials institutions.Eighty-two cases of outpatient patients who used single-use digital hysteroscope for hysteroscopy were included in experimental group,and 82 cases who underwent hysteroscopy by reusable hysteroscope(Storz Bettochi)were included in control group.The clinical diagnosis coincidence rate,performance score and incidence of adverse events of uterine imaging were recorded in the two groups.Results The coincidence rate of clinical diagnosis in the experimental group was 98.8%(80/82),1.22% lower than the 100%(82/82)in control group.And the difference of lower limit of 95% confidence interval between the experimental group and the control group was-3.60%,which was greater than the non-inferiority margin-10.00%.There was no significant difference in performance scores between the experimental group and the control group(P>0.05).The incidence of adverse events in the experimental group was 11.0%(9 cases,9 events),and serious adverse events incidence was 1.2%(1 case,1 event).In the control group,the incidence of adverse events was 9.8%(8 cases,9 events),and no serious adverse events occurred(0 cases,0 events).There was no significant difference in the incidence of adverse events or serious adverse events between two groups.Conclusions The overall performance of single-use digital hysteroscope for providing intrauterine images,observation and diagnosis is comparable to that of reusable hysteroscope,and the safety is also comparable.The performance of the single-use digital hysteroscope can meet the needs of outpatient hysteroscopy,and it can be an effective supplementary hysteroscopy technology.
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