Department of Andrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Department of Andrology, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.
BMJ Open. 2023 Jun 6;13(6):e068368. doi: 10.1136/bmjopen-2022-068368.
Infertility is a focal issue in public health and affects human reproduction and survival. Notably, an increasing number of studies in recent decades have found that sperm DNA integrity plays a critical role in the development of healthy embryos. Among the multiple pathogenic factors of sperm DNA fragmentation, oxidative stress has proven to be predominant. Coenzyme Q10 supplementation, which has been used for the treatment of male infertility, has shown good clinical efficacy due to its oxidation resistance, but its efficacy as measured by the sperm DNA fragmentation index remains controversial. To address this issue, we will perform a systematic review and meta-analysis to evaluate the efficacy of coenzyme Q10 for male infertility patients with a high sperm DNA fragmentation index.
The PubMed, Embase, Cochrane Central Register of Studies and Web of Science databases will be comprehensively searched from inception to 31 December 2022 to identify relevant studies published in the English language using appropriate search strategies. The search terms will be derived from the following concepts: sperm DNA fragmentation, coenzyme Q10 and randomised controlled trials. Two review stages, that is, title and abstract screening and full-text screening, will be performed by two reviewers. The risk of bias, publication bias and evidence grade of the included studies will be assessed using a standardised protocol. Data will be used to calculate effect sizes. Heterogeneity among the studies will be evaluated graphically. Subgroup analysis and sensitivity analysis will be performed if necessary to validate the results.
No ethical approval will be needed, as there will be no participants in this study. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the findings through publication and conference presentation.
CRD42022293340.
不孕是公共卫生的一个焦点问题，影响着人类的生殖和生存。值得注意的是，近几十年来越来越多的研究发现，精子 DNA 完整性在健康胚胎的发育中起着关键作用。在导致精子 DNA 碎片化的多种致病因素中，氧化应激已被证明是主要因素。辅酶 Q10 补充剂已被用于治疗男性不育症，由于其抗氧化作用，显示出良好的临床疗效，但其精子 DNA 碎片化指数的疗效仍存在争议。为了解决这个问题，我们将进行系统评价和荟萃分析，以评估辅酶 Q10 对精子 DNA 碎片化指数较高的男性不育患者的疗效。
我们将全面检索 PubMed、Embase、Cochrane 中央对照研究注册库和 Web of Science 数据库，从建库至 2022 年 12 月 31 日，使用适当的检索策略检索以英文发表的相关研究。检索词将来源于以下概念：精子 DNA 碎片化、辅酶 Q10 和随机对照试验。将由两名评审员进行标题和摘要筛选以及全文筛选两个评审阶段。将使用标准化方案评估纳入研究的偏倚风险、发表偏倚和证据等级。将使用数据计算效应大小。如果需要，将进行亚组分析和敏感性分析以验证结果。
本研究不需要伦理批准，因为研究中不会有参与者。我们将遵循系统评价和荟萃分析的首选报告项目准则，通过发表和会议演示传播研究结果。
CRD42022293340 号 PROSPERO 注册。
