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Abstract

Volume 16, Issue 3 (May 2014) 16, 432–436; 10.4103/1008-682X.122860

A randomised controlled multicentre contraceptive efficacy clinical trial of the intra-vas device, a non-occlusive surgical male sterilisation

Wen-Hong Lu1, Xiao-Wei Liang1, Yi-Qun Gu1, Wei-Xiong Wu2, Li-Wei Bo3, Tian-Gui Zheng4, Zhen-Wen Chen1

1 Key Laboratory of Male Reproductive Health,National Health and Family Planning Commission,National Research Institute for Family Planning & WHO Collaborating Centre for Research in Human Reproduction, Beijing, China.
2Institute for Family Planning of Guangzhou city, Guangzhou, China
3Institute for Family Planning of Henan Province, Zhengzhou, China
4Institute for Family Planning of Putian city, Putian, China

Correspondence: Dr. ZW Chen (nrifp2011@163.com)

Received: 12 April 2013; Revised: 30 June 2013; Accepted: 01 September 2013

Abstract

Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilisation with a non-obstructive intra-vas device (IVD) implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV). IVDs were categorised into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing) whereas IVD-A does not. A multicentre prospective randomised 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–6th and 12th post-operative 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 sterilisation exhibits a low risk of long-term adverse events and was found to be effective as a male sterilisation method, similar to the NSV technique. IVD male sterilisation is expected to be a novel contraceptive method.

Keywords: complication; male sterilization; nonobstructive intravas device; no‑scalpel vasectomy

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