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| Analysis of clinical trial registration status of male infertility in China |
| JIAO Weiwei1 PENG Juqin1 LU Yan1 LIU Shengjing2 QIAO Ruoyu2 GUO Jun2 |
1.Department of Encephalopathy, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;
2.Department of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China |
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Abstract Objective To explore the clinical trial registration status of male infertility in China. Methods From the establishment of Chinese Clinicle Trail Registry and National Library of Medicine Clinical Trial Registry database to October 2022, all registered clinical trials for male infertility in China were searched. Registration studies were screened according to the exclusion criteria, and information such as registration time, registration location, intervention measures, outcome indicators, and study design were extracted. Descriptive statistical methods were used for the analysis. Results A total of 96 studies were retrieved, 31 of which were eventually included, with a total sample size of 37 507 cases. Since 2018, the number of registrations had been increasing year by year. The main research methods were intervention studies (21 studies 67.74%), and the most research designs were randomized parallel controls (18 studies, 58.06%). The geographical distribution of sponsoring units was mainly in Zhengzhou, Beijing, Nanjing, Guangzhou, and Shanghai, and the nature of sponsoring units was mainly in hospitals and reproductive centers; funding mainly came from self-financing of hospitals (18 studies, 58.06%); the intervention measures mainly included drugs and non-drugs, among which the drugs were mainly proprietary Chinese medicines (7 studies, 33.33%), and the non-drugs included assisted reproduction and surgery. The outcome indexes were mainly semen quality, sex hormone level, and pregnancy rate. Conclusion Chinese medicine intervention measures include in the study accounted for a relatively high proportion and significant characteristics, mainly proprietary Chinese medicines with the effect of tonifying kidney and essence. Clinical trial registration in this field still has problems such as fewer registrations, uneven geographical distribution, and registration information not updated in time.
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[1] 李宏军，洪锴，李铮，等.男性不育诊疗指南[J].中华男科学杂志，2022，28（1）：66-76.
[2] Jarow JP，Sharlip ID，Belker AM，et al. Bestpracticepoliciesformaleinfertility [J]. J Urol，2002，167（5）：2138-2144.
[3] 于河，刘建平.国际临床试验注册概述[J].中西医结合学报，2007，5（3）：234-242．
[4] 吴泰相，李幼平，卞兆祥，等.中医药临床随机对照试验报告规范[J].中国循证医学杂志，2007，7（8）：601-605．
[5] 联合宣言工作组.创建中国临床试验注册和发表机制的联合宣言[J].中国中西医结合杂志，2006，36（7）：585-586.
[6] Tonks A. Registeringclinicaltrials [J]. BMJ，1999，319（7224）： 1565-1568．
[7] 张芳，孙自学，邱荃，等.益肾通络方治疗少弱精子型男性不育症肾虚瘀阻证的临床疗效[J].中国实验方剂学杂志，2021，27（11）：112-116.
[8] 赵盼盼，王祖龙，陈如兵.五味扶正益精汤对男性不育患者精子DNA完整性的影响[J].中国实验方剂学杂志，2023，29（3）：127-132.
[9] 苟成仁.左卡尼汀联合辅酶Q10在弱精症患者精液中补充对改善精子质量及妊娠的研究[D].遵义：遵义医科大学，2022.
[10] 金鑫瑶，郑文科，张俊华，等.推进真实世界研究的透明化[J].世界中医药，2019，14（12）：3106-3110.
[11] 邬兰，田国祥，王行环，等.临床试验的注册及注册平台比较分析[J].中国循证心血管医学杂志，2017，9（2）：129-134.
[12] 吴泰相，米娜瓦尔·阿不都，郝园，等.中国临床试验注册10年：现状与问题[J].中国循证医学杂志，2018，18（6）：522-525.
[13] 刘雪梅，李琰，蒋兰慧，等.实施研究伦理和发表伦理，促进规范研究、规范出版和规范转化——中国临床试验注册和发表协作网第二次声明背景文件[J].中国循证医学杂志，2011，11（7）：726-732.
[14] 吴泰相，卞兆祥，李幼平，等.临床试验原始数据透明化与共享：关于医学研究伦理的哲学命题及其对临床试验的意义[J].中国循证医学杂志，2018，18（6）：538-542.
[15] International Committee of Medical Journal Editors.Uniform requirements for manuscript submitted to biomedical jour- nals：writing and editing for biomedical publication[EB/OL].（2004-02-23）[2004-02-23].https：//www.icmje.org/recom mendations/archives/2004_urm.pdf.
[16] 张敏建，郭军，陈磊，等.男性不育症中西医结合诊疗指南（试行版）[J].中国中西医结合杂志，2015，35（9）：1034- 1038.
[17] 朱礼乐，卓进盛，邢益涛，等.五子衍宗丸加味治疗60例脾肾两虚型弱精子不育症患者的临床观察[J].世界中西医结合杂志，2021，16（10）：1920-1923，1928.
[18] 曹倩，周玲，王南南.针灸联合五子衍宗丸治疗肾气亏虚型弱精症疗效及对相关指标的影响[J].现代中西医结合杂志，2022，31（3）：393-396，438.
[19] 夏烨，姜姗，童国庆.龟龄集胶囊联合显微精索静脉高位结扎术对精索静脉曲张致不育症患者术后精液质量及受孕率影响的临床研究[J].上海中医药杂志，2017， 51（S1）：117-120.
[20] 郭军，张春影.龟龄集胶囊治疗少弱精子症的疗效观察[J].中国男科学杂志，2009，23（7）：48-50.
[21] 张芳，赵沛沛，孙自学，等.隔药灸脐法联合益肾通络方治疗肾阳虚络阻型特发性弱精子症不育的临床观察[J].中国实验方剂学杂志，2023，29（4）：97-103.
[22] 姜辉，商学军，郭军，等.复方玄驹胶囊治疗少弱精子症患者的多中心临床研究[J].中华男科学杂志，2008，14（8）：755-758.
[23] 杨长海，孙中义，王波，等.还少胶囊治疗少弱精子症的多中心临床观察[J].中华男科学杂志，2018，24（7）：635- 639.
[24] 郭军.“脑-心-肾-精室”轴在中医男科学中的理论构建及应用[J].世界中西医结合杂志，2020，15（8）：1553- 1556.
[25] 邓楹君，赵丰，郭俊，等.基于CiteSpace男性不育症中医药研究的知识图谱可视化分析[J].中国中西医结合杂志，2022，42（6）：693-697.
[26] 国家卫生健康委.关于印发加强辅助生殖技术服务机构和人员管理若干规定的通知[EB/OL].北京：国家卫生健康委，（2019-09-04）[2019-09-06].http：//www.nhc.gov.cn/fys/ s3581/201910/96a348f78136442bb5381d17be7fa0e7.shtml. |
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