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胚胎移植前阴道内使用益生菌对复发性植入失败病例的妊娠率无改善作用:一项随机对照试验。

Intravaginal probiotics before embryo transfer do not improve pregnancy rates in recurrent implantation failure cases: An RCT.

作者信息

Naghi Jafarabadi Mina, Hadavi Farnaz, Ahmadi Maedeh, Masoumi Masoumeh, Zabihzadeh Sara

机构信息

Vali-E-Asr Reproductive Health Research Center, Family Health Research Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Int J Reprod Biomed. 2024 Jul 8;22(5):363-374. doi: 10.18502/ijrm.v22i5.16435. eCollection 2024 May.

Abstract

BACKGROUND

Considering the considerable influence of the vaginal microbiome on endometrial receptivity and embryo implantation, we hypothesized that cases of recurrent implantation failure (RIF) might benefit from the intravaginal probiotic administration.

OBJECTIVE

Evaluation of the effects of intravaginal probiotic administration before frozen embryo transfer (FET) on the rates of pregnancy and the status of vaginal lactobacillary flora in cases of RIF.

MATERIALS AND METHODS

This was a randomized, parallel-group, clinical trial conducted at an infertility clinic in Tehran, Iran between January 2021 and September 2022. A total of 166 reproductive-aged women with a history of unexplained RIF were randomly assigned to either the probiotic group or the control group (n = 83/each group). The probiotic group received intravaginal probiotics (LactoVagⓇ) daily for 2 wk from the second day of the menstrual cycle along with the routine treatment of FET. The control group received only the routine treatment of FET. The primary outcome was the chemical pregnancy rate, and the secondary outcomes were the clinical pregnancy rate and the status of vaginal lactobacillary flora.

RESULTS

A total of 163 participants were included in the final analysis. The probiotic group had a slightly higher chemical pregnancy rate than the control group (39.02% vs. 33.33%), but the difference was not statistically significant (risk ratio: 1.71, 95% CI: 0.77-1.76; p = 0.449). The clinical pregnancy rate was also non-significantly higher in the probiotic group than the control group (37.80% vs. 33.33%; RR: 1.14, 95% CI: 0.76-1.74; p = 0.623).

CONCLUSION

Intravaginal probiotic administration did not significantly improve the pregnancy rates in RIF cases undergoing FET. Further studies are needed to explore the optimal dose, duration, and timing of probiotic administration, as well as the mechanisms of action and the potential adverse effects of probiotics on the vaginal microbiome and the implantation process.

摘要

背景

考虑到阴道微生物群对子宫内膜容受性和胚胎着床有相当大的影响,我们推测复发性植入失败(RIF)病例可能受益于阴道内给予益生菌。

目的

评估在冻融胚胎移植(FET)前阴道内给予益生菌对RIF病例的妊娠率和阴道乳杆菌菌群状态的影响。

材料与方法

这是一项于2021年1月至2022年9月在伊朗德黑兰一家不孕症诊所进行的随机、平行组临床试验。共有166名有不明原因RIF病史的育龄妇女被随机分为益生菌组或对照组(每组n = 83)。益生菌组从月经周期的第二天开始,每天阴道内给予益生菌(LactoVagⓇ),持续2周,同时进行FET的常规治疗。对照组仅接受FET的常规治疗。主要结局是化学妊娠率,次要结局是临床妊娠率和阴道乳杆菌菌群状态。

结果

共有163名参与者纳入最终分析。益生菌组的化学妊娠率略高于对照组(39.02%对33.33%),但差异无统计学意义(风险比:1.71,95%CI:0.77 - 1.76;p = 0.449)。益生菌组的临床妊娠率也略高于对照组,但差异无统计学意义(37.80%对33.33%;RR:1.14,95%CI:0.76 - 1.74;p = 0.623)。

结论

阴道内给予益生菌并不能显著提高接受FET的RIF病例的妊娠率。需要进一步研究来探索益生菌给药的最佳剂量、持续时间和时机,以及益生菌对阴道微生物群和着床过程的作用机制和潜在不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b96/11290200/9c2dcd1e50e9/ijrb-22-363-g001.jpg

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