为评估左旋诺孕酮缓释宫内节育系统（LNG-IUS）联合口服醋酸甲羟孕酮（MA）作为早期子宫内膜癌（EEC）患者保育生育治疗的效果，在这个单中心、开放标签、随机和对照的II期研究中，筛选出年轻患者（18-45岁）原发性EEC诊断且急需保育生育治疗的患者。患者随机分配（1：1）到MA组（每日口服160mg）或MA（每日口服160mg）加LNG-IUS组。每3个月进行一次经宫腔镜取得的子宫内膜病理学评估。主要终点是治疗16周内实现完全缓解（CR）率。二次终点是治疗32周内的CR率、不良事件、复发和妊娠率。自2017年7月至2020年6月，共有63例患者被招募并随机分配。完全纳入主要终点分析的有56名患者（MA组26名，MA+LNG-IUS组28名）。中位随访时间为31.6个月（范围为3.1-94.0）。MA组和MA+LNG-IUS组的16周CR率没有显著差异（19.2% vs. 25.0%，p=0.610；比值比=1.40；95%置信区间=0.38-5.12），32周CR率也相似（57.1%和61.5%，p=0.743）。与MA组相比，更多的MA+LNG-IUS组女性出现阴道出血（46.4% vs. 16.1%；p=0.012）。在复发和妊娠率方面，两组之间没有差异。与MA单独相比，添加LNG-IUS可能并未改善EEC的早期CR率，反而会产生更多的不良事件。ClinicalTrials.gov识别号：NCT03241914。© 2023年。Asian Society of Gynecologic Oncology、Korean Society of Gynecologic Oncology和Japan Society of Gynecologic Oncology。

To evaluate the effect of levonorgestrel-releasing intrauterine system (LNG-IUS) plus oral megestrol acetate (MA) as fertility-preserving treatment in patients with early-stage endometrial cancer (EEC).In this single-center, phase II study with open-label, randomized and controlled design, young patients (18-45 years) diagnosed with primary EEC were screened, who strongly required fertility-preserving treatment. Patients were randomly assigned (1:1) into MA group (160 mg oral daily) or MA (160 mg oral daily) plus LNG-IUS group. Pathologic evaluation on endometrium retrieved by hysteroscopy was performed every 3 months. The primary endpoint was complete response (CR) rate within 16 weeks of treatment. The secondary endpoints were CR rate within 32 weeks of treatment, adverse events, recurrent and pregnancy rate.Between July 2017 and June 2020, 63 patients were enrolled and randomly assigned. Totally 56 patients (26 in MA group; 28 in MA + LNG-IUS group) were included into primary-endpoint analyses. The median follow-up was 31.6 months (range, 3.1-94.0). No significant difference in 16-week CR rate were found between MA and MA + LNG-IUS groups (19.2% vs. 25.0%, p=0.610; odds ratio=1.40; 95% confidence interval=0.38-5.12), while the 32-week CR rates were also similar (57.1% and 61.5%, p=0.743), accordingly. More women in MA + LNG-IUS group experienced vaginal hemorrhage (46.4% vs. 16.1%; p=0.012) compared with MA group. No intergroup difference was found regarding recurrence or pregnancy rate.Compared with MA alone, the addition of LNG-IUS may not improve the early CR rate for EEC, and may produce more adverse events instead.ClinicalTrials.gov Identifier: NCT03241914.© 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.