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
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.
2023, Vol. 20 
京公网安备 11010502046598号