Lei Li-Xing, Li Ke-Cheng, Yu Wen-Hao, Feng Jun-Long, Zhang Hua-Nan, Chen Mao-Ke, Dong Wen-Xuan, Chen Ji-Xuan, Li Jie, Wang Ji-Sheng, Han Liang, Wang Bin
Department of Andrology, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, China.
The First Clinical Medical College, Beijing University of Chinese Medicine, Beijing, China.
Am J Mens Health. 2025 Mar-Apr;19(2):15579883251325478. doi: 10.1177/15579883251325478. Epub 2025 Apr 20.
This study aims to analyze the registration information and outcome transparency for five common andrological diseases, as well as the factors influencing result availability. A comprehensive search was performed on ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) to retrieve all clinical trial registration data related to the five defined andrological diseases from the inception of these databases up to September 1, 2024. The search extracted key trial details, including status, type, intervention, and result availability. Of 8,132 trials retrieved, 642 were analyzed. Among these, 259 trials (40.34%) reported results via ClinicalTrials.gov, ICTRP, or publications, while 113 trials (17.60%) made results publicly available on ClinicalTrials.gov or ICTRP. Among the five andrological diseases, male infertility had the highest rate of result availability (37/74, 50%), whereas benign prostatic hyperplasia exhibited the lowest (71/190, 37.37%). No significant differences were found across diseases (χ = 3.722, = 4, = .435). Factors such as study status, blinding, interventions, center type, location, and duration significantly influenced result availability, whereas study type, stage, funding, outcome indicators, and sample size did not. Clinical trials on andrological conditions show major gaps in registration and result disclosure, with low reporting rates and prevalent non-reporting and selective reporting. Developed countries dominate trial registration and result disclosure while developing countries have limited participation. Trial characteristics also influence result disclosure rates. These challenges compromise the integrity and credibility of research data, impede clinical practice, and hinder the progress of medical research. Measures are needed to improve transparency, reduce selective reporting, and enhance the rigor and credibility of andrology research.
本研究旨在分析五种常见男科疾病的注册信息和结果透明度,以及影响结果可获取性的因素。在ClinicalTrials.gov和国际临床试验注册平台(ICTRP)上进行了全面检索,以获取从这些数据库建立至2024年9月1日期间与五种定义的男科疾病相关的所有临床试验注册数据。检索提取了关键试验细节,包括状态、类型、干预措施和结果可获取性。在检索到的8132项试验中,对642项进行了分析。其中,259项试验(40.34%)通过ClinicalTrials.gov、ICTRP或出版物报告了结果,而113项试验(17.60%)在ClinicalTrials.gov或ICTRP上公开了结果。在五种男科疾病中,男性不育症的结果可获取率最高(37/74,50%),而良性前列腺增生症的结果可获取率最低(71/190,37.37%)。各疾病之间未发现显著差异(χ = 3.722,自由度 = 4,P = 0.435)。研究状态、盲法、干预措施、中心类型、地点和持续时间等因素显著影响结果可获取性,而研究类型、阶段、资金、结果指标和样本量则没有影响。男科疾病的临床试验在注册和结果披露方面存在重大差距,报告率低,普遍存在不报告和选择性报告的情况。发达国家在试验注册和结果披露方面占主导地位,而发展中国家的参与有限。试验特征也影响结果披露率。这些挑战损害了研究数据的完整性和可信度,阻碍了临床实践,并妨碍了医学研究的进展。需要采取措施提高透明度,减少选择性报告,并增强男科研究的严谨性和可信度。