A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization

• Published in: Asian journal of andrology Vol. 16; no. 3; pp. 432 - 436
• Main Authors: Lu, Wen-Hong, Liang, Xiao-Wei, Gu, Yi-Qun, Wu, Wei-Xiong, Bo, Li-Wei, Zheng, Tian-Gui, Chen, Zhen-Wen
• Format: Journal Article
• Language: English
• Published: China Medknow Publications and Media Pvt. Ltd 01.05.2014; Medknow Publications & Media Pvt. Ltd; Medknow Publications & Media Pvt Ltd; Wolters Kluwer Medknow Publications
• Subjects: Adult; Birth control; China; Clinical trials; complication; male sterilization; nonobstructive intravas device; no-scalpel vasectomy; Contraceptives; Equipment Design; Female; Humans; Laboratories; Male; Middle Aged; Motility; Original; Pregnancy; Product development; Prospective Studies; Reproductive sterilization; Sperm; Sperm Count; Sperm Motility; Sterilization, Reproductive - adverse effects; Sterilization, Reproductive - instrumentation; Sterilization, Reproductive - methods; Studies; Treatment Outcome; Vas Deferens - surgery; Vasectomy; Vasectomy - adverse effects; Young Adult; 临床试验; 多中心; 手术刀; 男性; 绝育; 输精管结扎术; 避孕方法; 随机分配; China
• ISSN: 1008-682X; 1745-7262; 1745-7262
• DOI: 10.4103/1008-682X.122860

Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device （IVD） implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy （NSV）. IVDs were categorized into two types： IVD-B has a tail used for fixing to the vas deferens （fixed wing） whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A （n = 487）, IVD-B （n = 485） or NSV （n = 487） groups and underwent operation. Follow-up included visits at the 3rd-6TM and 12~ postoperative months, The assessments of the subjects involved regular physical examinations （including general and andrological examinations） and semen analysis. The subjects＇ partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests, There were no significant differences in pregnancy rates （0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV） among the three groups （P 〉 0.05）. The cumulative rates of complications at the 12th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method.