施孕可辅助授精系统治疗男性不育症的多中心、前瞻性、开放、自身对照、随机交叉的临床研究  

Multi-center,prospective,open self-controlled,randomly crossed trial on the treatment with the conception aid kit in male infertility

作　　者：田汝辉[1] 叶臻[2] 郭通航[3] 孙红芳[1] 吴煜[4] 周莉娜[4] 纪晓宁 陈冬丽[2] 宋苏 孙晓科[3] 王一洲 薛云婧 周慧[2] 胡斌 栾红兵[3] 熊承良[2] 李铮[1] Tian Ruhui;Ye Zhen;Guo Tonghang;Sun Hongfang;Wu Yu;Zhou Lina;Ji Xiaoning;Chen Dongli;Song Su;Sun Xiaoke;Wang Yizhou;Xue Yunjing;Zhou Hui;Hu Bin;Luan Hongbing;Xiong Chengliang;Li Zheng(Andrology Department of Urology Clinic Medicine Center,Shanghai General Hospital,Shanghai Jiao Tong University,Men's Health Assessment Center,Institute of Urology,Shanghai Jiao Tong University,Shanghai Key Laboratory of Reproductive Medicine,Shanghai 201620,China;Reproductive Medicine Center,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Reproductive Center,Anhui Provincial Hospital,Hefei 230001,China;Assisted Reproduction Shanghai General Hospital,Shanghai Jiao Tong University,Shanghai 201620,China)

机构地区：[1]上海交通大学附属第一人民医院泌尿外科临床医学中心男科上海交通大学泌尿外科研究所男性健康评估中心,上海市生殖医学重点实验室,201620 [2]华中科技大学同济医学院生殖医学中心,武汉430030 [3]安徽省立医院生殖中心,合肥230001 [4]上海交通大学附属第一人民医院辅助生殖科,201620

出　　处：《中华生殖与避孕杂志》2020年第9期734-740,共7页Chinese Journal of Reproduction and Contraception

摘　　要：目的与自然性交法比较,评价施孕可辅助授精系统治疗不育症的安全性和有效性。方法采用多中心、开放、自身对照、随机交叉的试验设计方法,分析了2017年7月至2018年9月期间在上海交通大学附属第一人民医院、华中科技大学同济医学院生殖医学中心和安徽省立医院就诊的无法自然妊娠的57对不育症夫妇,采用自身对照的方法,对比前后两个排卵期中使用本辅助授精系统方法与自然性交方法的差异。符合入组条件的患者夫妇应用随机信封法来决定使用上述两种治疗方法的先后顺序。其中A类29对夫妇,第一个月的排卵期使用辅助授精系统的治疗方法,第二个月的排卵期使用自然性交法;B类28对夫妇,第一个月的排卵期使用自然性交法,第二个月的排卵期使用辅助授精系统的治疗方法。所有完成辅助授精系统的夫妇的资料汇总为试验组数据,同时完成自然性交的夫妇的资料汇总为对照组数据,进行自身对照比较,采用妇科阴道检查、白带常规检查、性交后试验对宫颈管内活动精子数量评分、妊娠率比较等方法验证本辅助授精系统应用的安全性和有效性。结果本研究完成试验的有效受试者共54对,其中A类26对夫妇,B类28对夫妇。有效性评价方面,性交后试验结果显示,试验组活动精子评分值为6.11±3.00,对照组活动精子评分值为1.22±0.79,试验组的活动精子评分值是对照组的5倍(P<0.001),明显优于对照组。受试者中有7例使用本辅助授精系统后成功妊娠,妊娠率为13.0%;其中6例已生育健康子代,1例自然流产,无受试者采用自然性交法后妊娠。安全性评价方面,试验组和对照组阴道一般妇科检查及阴道白带常规检查结果显示,试验组与对照组检查结果无差异。完成试验的54对有效受试者均能顺利使用本辅助授精系统放置含有精液的储精囊并在6 h内使用拉线顺利取出,无明显不适Objective To evaluate the safety and effectiveness of The Stork OTC conception aid kit for the treatment of male infertility compared with natural sexual intercourse.Methods A multi-center,prospective,open,self-controlled,randomly crossed trial was performed in 57 infertility couples who were unable to naturally conceive,and were selected in Shanghai General Hospital,Shanghai Jiao Tong University,Reproductive Medicine Center,Tongji Medical College,Huazhong University of Science and Technology and Anhui Provincial Hospital from July 2017 to September 2018.Patients were required to participate both the conception aid kit and natural sexual intercourse in two consecutive periods of ovulation.A random envelope method was used to determine the application sequences of two methods.Twenty-nine couples were treated with the conception aid kit in the first month of ovulation,and applied the natural sexual intercourse in the second month of ovulation as group A.Twenty-eight couples were applied the natural sexual intercourse in the first month of ovulation,and were treated with the conception aid kit in the second month of ovulation as group B.Test results collected from all couples who used the conception aid kit were categorized as the test group data.Meanwhile,test results out of those couples who completed natural sexual intercourse were collected as control group data.Compared with its self-controlled natural sexual intercourse two months before and after,the effectiveness and safety of the conception aid kit was verified by general vaginal examination,routine leucorrhea examination,motile sperm score from post coital test(PCT),pregnancy rate comparison and other methods.Results The trial was conducted at three clinical trial centers.A total of 57 infertility couples were enrolled.A total of 54 couples were validated eventually including 26 couples in group A and 28 infertility couples in group B.Effectiveness was evaluated.The PCT results showed that the sperm score of test group was 6.11±3.00,and the score of the s

关 键 词：辅助授精系统 男性不育症 有效性 安全性 

分 类 号：R698.2[医药卫生—泌尿科学] R714.8[医药卫生—外科学]