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粒细胞巨噬细胞集落刺激因子(GM-CSF)在持续性薄型子宫内膜患者中的治疗作用:一项前瞻性随机研究。

Therapeutic role of granulocyte macrophage colony-stimulating factor (GM-CSF) in patients with persistent thin endometrium: A prospective and randomized study.

机构信息

Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

出版信息

Int J Gynaecol Obstet. 2020 Aug;150(2):194-199. doi: 10.1002/ijgo.13152. Epub 2020 May 6.

Abstract

OBJECTIVE

To assess the effect of granulocyte macrophage colony-stimulating factor (GM-CSF) on unresponsive thin (<7 mm) endometrium in women undergoing frozen-thawed embryo transfer.

METHODS

A single-center, randomized, prospective study enrolled 304 women with thin unresponsive endometrium from Shanghai Ninth People's Hospital between March 2017 and May 2018. Of them, 161 patients received an intrauterine infusion of GM-CSF and 143 patients served as controls. After hysteroscopy, a gel with or without GM-CSF was administered to fill the uterine cavity completely or up to 5 mL only. The primary outcome was confirmed pregnancy and secondary outcomes included endometrial thickness and implantation rate.

RESULTS

Patients who were administered GM-CSF had a significantly higher chemical pregnancy rate (35.3% vs 20.0%; P=0.009) and clinical pregnancy rate (28.6% vs 13.3%; P=0.005) compared with patients in the control group. Patients treated with GM-CSF had significantly higher endometrial thickness compared with controls (7.83 ± 1.45 mm vs 7.37 ± 0.70 mm, P=0.003).

CONCLUSION

GM-CSF therapy can effectively increase endometrial thickness and improve the clinical pregnancy rate in patients with persistent thin endometrium. The therapeutic role of GM-CSF for infertile women under in vitro fertilization and embryo transfer (IVF-ET) treatment can be further explored.

CHINESE CLINICAL TRIAL REGISTER

ChiCTR-IPR-17011242.

摘要

目的

评估粒细胞-巨噬细胞集落刺激因子(GM-CSF)对接受冻融胚胎移植的无反应性薄型(<7mm)子宫内膜的作用。

方法

一项单中心、随机、前瞻性研究纳入了 2017 年 3 月至 2018 年 5 月期间上海第九人民医院的 304 例薄型无反应性子宫内膜患者。其中 161 例患者接受宫腔内 GM-CSF 灌注,143 例患者作为对照组。宫腔镜检查后,用或不用 GM-CSF 的凝胶完全填充宫腔或仅填充至 5mL。主要结局为确认妊娠,次要结局包括子宫内膜厚度和着床率。

结果

接受 GM-CSF 治疗的患者化学妊娠率(35.3%比 20.0%;P=0.009)和临床妊娠率(28.6%比 13.3%;P=0.005)显著高于对照组。GM-CSF 治疗组的子宫内膜厚度明显高于对照组(7.83±1.45mm 比 7.37±0.70mm,P=0.003)。

结论

GM-CSF 治疗可有效增加子宫内膜厚度,提高持续性薄型子宫内膜患者的临床妊娠率。GM-CSF 对体外受精-胚胎移植(IVF-ET)治疗不孕妇女的治疗作用可以进一步探讨。

中国临床试验注册中心

ChiCTR-IPR-17011242。

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