NCT00612833

A Randomized Controlled Trial of Three Vasectomy Techniques

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: FHI 360 · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study will be a randomized, controlled multicenter trial, conducted jointly by the Indian Council of Medical Research, New Delhi and Family Health International, which will compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV) approach to isolation of the vas: 1. ligation and excision of about 1 cm of the vas, with fascial interposition; 2. intraluminal thermal cautery with excision of about 1 cm of the vas; 3. intraluminal thermal cautery with excision of about 1 cm of the vas combined with fascial interposition. A total of 1500 healthy, sexually active men at least 21 years old who have chosen vasectomy as a means of contraception will be recruited at four to six study sites in India. The success of the vasectomy procedure will be determined based on semen analysis results. All men should have semen analyses at 8 and 12 weeks post-vasectomy. All men will be asked to attend a final visit at 12 months.

Detailed description

This study will be a randomized, controlled multicenter trial, conducted jointly by the Indian Council of Medical Research, New Delhi and Family Health International, which will compare three vasectomy occlusion techniques, all using the no-scalpel vasectomy (NSV) approach to isolation of the vas: 1. ligation and excision of about 1 cm of the vas, with fascial interposition; 2. intraluminal thermal cautery with excision of about 1 cm of the vas; and, 3. intraluminal thermal cautery with excision of about 1 cm of the vas combined with fascial interposition. A total of 1500 healthy, sexually active men at least 21 years old who have chosen vasectomy as a means of contraception will be recruited at four to six study sites in India. The success of the vasectomy procedure will be determined based on semen analysis results. All men should have semen analyses at 8 and 12 weeks post-vasectomy. All men will be asked to attend a final visit at 12 months.

Conditions

• Contraception

Interventions

Type	Name	Description
PROCEDURE	Vasectomy occlusion techniques	Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition

Timeline

• Start date: 2009-01-01
• First posted: 2008-02-12
• Last updated: 2013-09-10

Locations

5 sites across 1 country: India