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粒细胞集落刺激因子与人绒毛膜促性腺激素治疗卵胞浆内单精子注射反复着床失败:一项随机临床试验。

Granulocyte colony stimulating factor versus human chorionic gonadotropin for recurrent implantation failure in intra cytoplasmic sperm injection: a randomized clinical trial.

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Fayoum University, Fayoum, Egypt.

Department of Obstetrics and Gynecology, Faculty of Medicine, Alazhar University, Cairo, Egypt.

出版信息

BMC Pregnancy Childbirth. 2022 Nov 29;22(1):881. doi: 10.1186/s12884-022-05098-9.

DOI:10.1186/s12884-022-05098-9
PMID:36447142
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9706918/
Abstract

BACKGROUND

Repeated implantation failure (RIF) is defined as the case whereby the transferred embryos fail to implant after several attempts of In vitro fertilization (IVF) which causes a profound impact on the quality of life and financial burden. Some clinical studies have confirmed that Granulocyte colony-stimulating factor (G-CSF) and human chorionic gonadotropin (HCG) can improve pregnancy outcomes and implantation rates. Hence, our study aims to compare the efficacy of G-CSF and HCG on pregnancy outcomes in RIF women who undergo intra-cytoplasmic sperm injection (ICSI).

METHODS

This randomized, single-blinded study was conducted et al.-Azhar University Hospitals, Cairo, Egypt, between 10 October 2020 and 20 December 2020. The study included 100 women aged 20-43 years old undergoing ICSI cycles, with a history of RIF. Patients were divided randomly into two groups: group (1): included 50 patients injected with 500 IU of intrauterine HCG on embryo transfer day, and group (2): Included 50 patients injected with G-CSF on the embryo transfer day.

RESULTS

In 100 RIF women, we found a significant improvement in pregnancy outcomes favoring G-CSF over HCG including implantation rate, chemical pregnancy, and clinical pregnancy (P < 0.0001, P = 0.0003, and P = 0.0006, respectively).

CONCLUSION

For the first time, we demonstrated a significant improvement in pregnancy outcomes favoring G-CSF over HCG in terms of implantation rate, chemical pregnancy, and clinical pregnancy.

TRIAL REGISTRATION

The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202010482774275 and was approved on 2 October 2020.

摘要

背景

反复着床失败(RIF)定义为多次体外受精(IVF)尝试后胚胎未能着床,这对生活质量和经济负担产生了深远的影响。一些临床研究已经证实,粒细胞集落刺激因子(G-CSF)和人绒毛膜促性腺激素(HCG)可以提高妊娠结局和着床率。因此,我们的研究旨在比较 G-CSF 和 HCG 对接受胞浆内精子注射(ICSI)的 RIF 妇女妊娠结局的影响。

方法

这是一项随机、单盲研究,在埃及开罗 Azhar 大学医院进行,时间为 2020 年 10 月 10 日至 2020 年 12 月 20 日。研究纳入了 100 名年龄在 20-43 岁之间、有 RIF 病史的接受 ICSI 周期的妇女。患者被随机分为两组:组 1:50 例患者在胚胎移植日注射 500IU 宫内 HCG;组 2:50 例患者在胚胎移植日注射 G-CSF。

结果

在 100 名 RIF 妇女中,我们发现 G-CSF 组在妊娠结局方面明显优于 HCG 组,包括着床率、化学妊娠和临床妊娠(P<0.0001、P=0.0003 和 P=0.0006)。

结论

我们首次证明,在着床率、化学妊娠和临床妊娠方面,G-CSF 组的妊娠结局明显优于 HCG 组。

试验注册

该研究在泛非临床试验注册中心注册,注册号为 PACTR202010482774275,并于 2020 年 10 月 2 日获得批准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/496b/9706918/5934848e6774/12884_2022_5098_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/496b/9706918/60bd3fe6b5df/12884_2022_5098_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/496b/9706918/5934848e6774/12884_2022_5098_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/496b/9706918/60bd3fe6b5df/12884_2022_5098_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/496b/9706918/5934848e6774/12884_2022_5098_Fig2_HTML.jpg

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本文引用的文献

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Efficacy of therapies and interventions for repeated embryo implantation failure: a systematic review and meta-analysis.反复胚胎植入失败的治疗方法和干预措施的疗效:一项系统评价和荟萃分析。
Sci Rep. 2021 Jan 18;11(1):1747. doi: 10.1038/s41598-021-81439-6.
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Intrauterine perfusion immunotherapies in recurrent implantation failures: Systematic review.宫腔内灌注免疫疗法治疗反复种植失败:系统评价。
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Human chorionic gonadotropin promotes recruitment of regulatory T cells in endometrium by inducing chemokine CCL2.
粒细胞集落刺激因子(G-CSF)在至少经历一次着床失败的女性中的价值:系统评价和荟萃分析。
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Uterine infusion strategies for infertile patients with recurrent implantation failure: a systematic review and network meta-analysis.复发性种植失败不孕患者的子宫输注策略:系统评价和网络荟萃分析。
Reprod Biol Endocrinol. 2024 Apr 16;22(1):44. doi: 10.1186/s12958-024-01221-x.
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