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宫腔内粒细胞集落刺激因子给药治疗复发性种植失败(RIF):一项 RCT

Intrauterine G-CSF Administration in Recurrent Implantation Failure (RIF): An Rct.

机构信息

Istinye University Liv Hospital Bahcesehir, Department of IVF, Istanbul, Turkey.

Bahcesehir University, Department of Obstetrics and Gynecology, Istanbul, Turkey.

出版信息

Sci Rep. 2020 Mar 20;10(1):5139. doi: 10.1038/s41598-020-61955-7.

Abstract

This study investigates the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group with normal endometrium. This study was designed as a prospective randomized controlled trial with the involvement of 157 RIF group pati; ents. The RIF group was formed on the basis of the RIF criteria: "The failure to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years. The study sample included 82 patients in the G-CSF group who received G-CSF once a day on hCG. The procedure was performed by administering 30 mIU of Leucostim®(Filgrastim [G-CSF] 30 mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL was infused into the endometrial cavity in the same way in 75 patients in the control group. The standard ICSI procedure was used for all patients, and fresh cycle embryos were transferred on the third or fifth day. No statistically significant difference was identified in clinical pregnancy rates, miscarriage rates and live birth rates between the G-CSF group and the control group (p = 0.112, p = 0.171, p = 0.644, respectively), and no difference was observed between the two groups regarding endometrial thickness (p = 0.965). The intervention of administration G-CSF into the uterine cavity in RIF patients with normal endometrium, did not alter the endometrial thickness, clinical pregnancy rates, or live birth rates.

摘要

本研究旨在探讨宫内粒细胞集落刺激因子(G-CSF)对子宫内膜厚度、临床妊娠率和活产率的影响,研究对象为子宫内膜正常的复发性植入失败(RIF)患者。本研究为前瞻性随机对照试验,共纳入 157 例 RIF 患者。RIF 组的纳入标准为:“年龄<40 岁的患者,在至少 3 个新鲜或冷冻周期中,每次移植至少 4 枚优质胚胎后仍未获得临床妊娠”。研究样本包括 82 例 G-CSF 组患者,每日给予 G-CSF 1 次,于 hCG 日经宫腔缓慢输注 30 mIU 的 Leucostim®(Filgrastim [G-CSF] 30 mIU/mL;DEM Medical,Dong-A;韩国)。对照组 75 例患者同样经宫腔缓慢输注 1 mL 生理盐水。所有患者均采用标准的卵胞浆内单精子注射(ICSI)程序,第 3 或第 5 天移植新鲜周期胚胎。G-CSF 组与对照组的临床妊娠率、流产率和活产率差异均无统计学意义(p=0.112,p=0.171,p=0.644),两组患者的子宫内膜厚度也无差异(p=0.965)。在子宫内膜正常的 RIF 患者中,宫腔内给予 G-CSF 干预并未改变子宫内膜厚度、临床妊娠率或活产率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b8d9/7083859/189deb3f1693/41598_2020_61955_Fig1_HTML.jpg

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