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宫腔内灌注粒细胞集落刺激因子对接受体外受精/卵胞浆内单精子注射周期的女性子宫内膜参数及受精结局的影响:一项随机对照试验

Effect of Intrauterine Perfusion of Granulocyte Colony-stimulating Factor on Endometrial parameters and Fertilization Outcome in Women Undergoing Fertilization/Intracytoplasmic Sperm Injection Cycles: A Randomized Controlled Trial.

作者信息

Jain Shivani, Mahey Reeta, Malhotra Neena, Kalaivani Mani, Sangeeta Pant, Bhatt Ashok, Singh Neeta, Kriplani Alka

机构信息

Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.

Department of Statstics, All India Institute of Medical Sciences, New Delhi, India.

出版信息

J Hum Reprod Sci. 2018 Jul-Sep;11(3):254-260. doi: 10.4103/jhrs.JHRS_20_18.

DOI:10.4103/jhrs.JHRS_20_18
PMID:30568355
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6262668/
Abstract

CONTEXT

Studies have found intrauterine perfusion of granulocyte colony-stimulating factor (G-CSF) to improve endometrial thickness and implantation rates in women undergoing fertilization (IVF).

AIMS

To study the effect of intrauterine perfusion of G-CSF on endometrial parameters and IVF outcomes in patients undergoing fresh embryo transfers.

SETTINGS AND DESIGN

This was a randomized double-blinded placebo-controlled trial conducted at assisted reproduction unit of a tertiary care center.

SUBJECTS AND METHODS

One hundred and fifty patients undergoing IVF/intracytoplasmic sperm injection (ICSI) treatment and fresh embryo transfers were randomized to intervention and placebo groups. Patients in the intervention group received intrauterine perfusion of 300 μg (0.5 ml) of G-CSF on the day of ovulation trigger. Patients in placebo group received intrauterine perfusion of 0.5 ml normal saline on the day of ovulation trigger. The primary outcome measure was clinical pregnancy rate. The secondary outcome measures were change in endometrial thickness, volume, and vascularity on the day of embryo transfer; biochemical pregnancy rate, implantation rate, ongoing pregnancy rate, and live birth rate. Statistical analysis was carried out using STATA 12.0 (StataCorp LP, College Station, Texas, USA).

RESULTS

Endometrial vascularity in the intervention group was significantly higher on the day of embryo transfer compared to the placebo group. Clinical pregnancy rate was 27.6% in the intervention group compared to 18.9% in the placebo group and the difference was not statistically significant ( = 0.207). There was no statistically significant difference between biochemical pregnancy rate, implantation rate, ongoing pregnancy rate, live birth rate and endometrial parameters between the two groups.

CONCLUSIONS

Routine use of G-CSF in unselected IVF cycles may not lead to increase in positive IVF outcomes. More trials with larger sample sizes are required before approving or refuting the role of routine G-CSF in increasing IVF success rates. (CTRI/2017/10/010310).

摘要

背景

研究发现,对接受体外受精(IVF)的女性进行粒细胞集落刺激因子(G-CSF)宫腔灌注可改善子宫内膜厚度和着床率。

目的

研究G-CSF宫腔灌注对接受新鲜胚胎移植患者的子宫内膜参数及IVF结局的影响。

设置与设计

这是一项在三级医疗中心辅助生殖科进行的随机双盲安慰剂对照试验。

研究对象与方法

150例接受IVF/卵胞浆内单精子注射(ICSI)治疗及新鲜胚胎移植的患者被随机分为干预组和安慰剂组。干预组患者在扳机日接受300μg(0.5ml)G-CSF宫腔灌注。安慰剂组患者在扳机日接受0.5ml生理盐水宫腔灌注。主要结局指标为临床妊娠率。次要结局指标为胚胎移植日子宫内膜厚度、体积和血管化的变化;生化妊娠率、着床率、持续妊娠率和活产率。使用STATA 12.0(美国德克萨斯州大学站StataCorp LP公司)进行统计分析。

结果

与安慰剂组相比,干预组胚胎移植日的子宫内膜血管化程度显著更高。干预组的临床妊娠率为27.6%,安慰剂组为18.9%,差异无统计学意义(P = 0.207)。两组之间的生化妊娠率、着床率、持续妊娠率、活产率及子宫内膜参数均无统计学显著差异。

结论

在未选择的IVF周期中常规使用G-CSF可能不会提高IVF阳性结局。在认可或否定常规使用G-CSF对提高IVF成功率的作用之前,需要更多样本量更大的试验。(CTRI/2017/10/010310)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73a3/6262668/c1e6c20336f5/JHRS-11-254-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73a3/6262668/c1e6c20336f5/JHRS-11-254-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73a3/6262668/c1e6c20336f5/JHRS-11-254-g001.jpg

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