关键词: 临床研究, 伦理问题, 知情同意, 早发性卵巢功能不全, 临床试验注册

Abstract:

Objective： Through the public registration information of the Chinese clinical trial registry （ChiCTR）， we investigated and analyzed the current status of domestic premature ovarian insufficiency （POI） disease research.Methods： Search the ChiCTR website using the search term "premature ovarian insufficiency" to collect POI-related registration items. The search time is up to January 1， 2024， and descriptive analysis methods are used for classification and summary.Results： A total of 43 POI-related studies were conducted； mainly interventional studies （30 items， 69.77%）； randomized parallel control studies were the most common （19 items， 44.19%）； 37 were pre-registered （86.05%）， and 6 were re-registered. The units responsible for the research implementation （team leader） are mainly concentrated in Beijing， Guangdong and Jiangsu， and mainly in tertiary hospitals （38 items， 88.37%）； the minimum sample size is 9 cases， and the maximum sample size is 6000 cases. There were 28 items （65.12%） intervention for traditional Chinese medicine and acupuncture； the main observation indicators were FSH， AMH， E₂， and LH； 95.35% of the studies were approved by the ethics committee， and 51.16% of the studies stated that they were willing to share data.Conclusion： The number of POI research registrations show an increasing trend from 2017 to 2023. The registration completeness is good， but the total number of registrations is small. There are still deficiencies in research compliance and data sharing awareness. It is necessary to continue to publicize and promote clinical research registration， improve the awareness of clinical researchers， and encourage the improvement of clinical research methodological capabilities.

Key words: Clinical research； , Ethical issues； , Informed consent； , Premature ovarian insufficiency； , Clinical trial registry