Multi-center, prospective, open self-controlled, randomly crossed trial on the treatment with the conception aid kit in male infertility
10.3760/cma.j.cn101441-20190829-00388
- VernacularTitle: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
- Author:
Ruhui TIAN
1
;
Zhen YE
;
Tonghang GUO
;
Hongfang SUN
;
Yu WU
;
Lina ZHOU
;
Xiaoning JI
;
Dongli CHEN
;
Su SONG
;
Xiaoke SUN
;
Yizhou WANG
;
Yunjing XUE
;
Hui ZHOU
;
Bin HU
;
Hongbing LUAN
;
Chengliang XIONG
;
Zheng LI
Author Information
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
- Publication Type:Journal Article
- Keywords:
Conception aid kit;
Male infertility;
Effectiveness;
Safety
- From:
Chinese Journal of Reproduction and Contraception
2020;40(9):734-740
- CountryChina
- Language:Chinese
-
Abstract:
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 sperm score of control group was 1.22±0.79. The motile sperm score of test group was 5 times ( P<0.001) than that in control group. In the follow-up, 7 (13.0%) of the couples successfully achieved pregnancy with the conception aid kit, 6 (85.7%) of them had healthy offspring, 1 (14.3%) had spontaneous abortion. No couples were pregnant after natural sexual intercourse. Safety was evaluated. The general examination of the vagina and the routine tests of the vaginal leukorrhea showed no difference between test group and control group. All 54 effective couples who completed the test can successfully use the conception aid kid to place the seminal vesicles containing semen and remove them with the attached pulling thread on time without obvious discomfort. Conclusion:The Stork OTC conception aid kits can effectively treat infertility, significantly increase the number of forward-moving sperm entering the cervix, and significantly increase the pregnancy rate. It is safe, non-invasive, simple, can be easily operate by patients themselves, and meets the needs of clinical applications.
