Research On Organization And Implementation Of The Clinical Trial Effect Of Acupuncture And Clomiphene Citrate On Live Birth In Infertile Women With Polycystic Ovary Syndrome

Traditional Chinese Medicine(TCM)is an valuable assest of civilization in our courntry.which dates back to more than 5,000 years.It is the only health resource with Chinese characteristics.In recent years,with the development of evidence-based medicine and introduction of methodology,our traditional medicine has carried out our collaborative innovation situation,"internationalization”of Chinese Medicine is the general trend of China’s health development.Objective:To analyze the organization and basic implementation of PCOSAct project<Effect of Acupuncture and Clomiphene Citrate on Live Birth in Infertile Women with Polycystic Ovary Syndrome:A Randomized controlled Trial>,from infrastructure construction,design optimization strategies,multi-center、multi-person collaboration,the whole process of working together at home and abroad,to explore the new ideas of construction and management in large-scale clinical trials.and provide a reference for other RCT research in the future.Methods:According to the order,complying with the requirements of transparency in clinical trials,from the aspect of organization structure,implementation content,design optimization,and SC meetings to analyse and summary the implementation process and design optimization of this PCOSAct proposal.Result:1.From the design optimization,implementation process,quality control,statistics and papers output,the relevant domestic and foreign experts have attended the whole process,and all documents related to bilingual.2.CC combined with acupuncture,not only confirm the effect of western medicine,but also give full play to the advantages of Chinese medicine treatment and add the curative effect of traditional Chinese medicine,according to its clinical problem(low live-birth rate and adverse reaction).3.In RCT trials,acupuncture control group in not the blank group,but to choose the comparison of different positions and intensity,makes the final effect more convinced!4.Project management has taken a "personnel responsibility system".formulated the pregnancy follow-up commissioner,adverse events follow-up commissioner and blood samples follow-up commissioner,ensure the quality of the subject.Conclusion:1."Internationalization" has become the major trend of the development of Chinese medicine in this century,giving full play to the advantages of combining traditional Medicine and western medicine,seize evidence-based medicine commanding heights in the academic frontier.2.Attach importance to the innovation of the effect assessment of TCM,solve the "bottleneck" problem in evaluating curative effect of Chinese medicine and western medicine therapy.3.According to the research purpose to detemine the final outcome indicators of the clinical trials,only to definite curative effect evaluation standard to make the test of scientific value to obtain international recognition.