Strategy And Correlation Analysis Of Pregnancy Follow-Up In Large Clinical Trial Of Infertility

Objective:Based on PCOS act, this article detailedly introduces the follow-up methods of pregnancy in a large infertility clinical trial, summarizes experience from the difficulties during follow-up, emphasizes the importance of pregnancy follow-up and provides reference for high-quality implementation and comprehensive collection of data in future clinical trials. According to the analysis of relevant factors to pregnancy outcomes in PCOS act, we expect to find factors affecting conception rate, pregnancy rate, live birth rate and pregnancy complications (e.g.diabetes mellitus and hypertension) which can offer evidence for clinical practice.Method:Firstly, we got pertinent information and materials through pregnancy follow-up. Follow-up content contains pregnancy education to pregnant subjects, collection of adverse effects and serious adverse effects, obtaining the evidence of pregnancy outcomes; Specialized person who collected information by electronic tools such as phone, we chat and mail are responsible for the follow-up; Put up with solutions to the problems encountered during follow-up such as change of research assistants, confidentiality of medical information and low comliance of patients. Secondly, we collected all the statistics (i.e., electronic data base, paper case report form, quality monitoring document) and analized factors that influence conception rate, pregnancy rate and pregnancy complications.Results:1. In 25 centers, local center in Hunan has highest conception rate, local center in Dalian has highest pregnancy rate and live birth rate; 2. About the effect of hospital types on pregnancy rate, traditional Chinese medicine hospital has highest pregnancy rate, followed by western medicine hospital, the last is combined traditional Chinese and western medicine hospital; 3. About the impact of area on pregnancy induced hypertension, the prevalence rate in the north is higher than that in the south.Conclusions:1. This project demonstrated the integration between modern management of clinical trial and clinical practice. The "specialized person in charge of special assignment" system ensured the authenticity, effectiveness and scientificity of the pregnancy outcomes; 2. By analyzing the conception and pregnancy rate in each local centers, we know the scientific research attitude of the researchers in each local centers because rigirous attitude and passion for scientific research are prerequisite to improving endpoint indicators of infertility; secondly, through pregnancy follow-up we can get the data about conception rate, pregnancy rate, live birth rate, these rates were about 30%,20% and 20%,respectively.3. In future clinical trials, it is recommended that screening for local center should focus on characteristics of diseases, advantage of departments, number of patients, trust between doctor and patient; 4. Based on the analysis of the effect of regional difference (south and north) on pregnancy complications, clinical practitioners should carry out reasonable monitoring and health guidance to patients in line with their living environment. The prevalence of diabetes mellitus and hypertension in pregnancy complications were 12.5% and 5.6%, respectively.