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A Randomized Controlled Trial of Three Vasectomy Techniques

NCT00612833 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-09-10

No results posted yet for this study

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.

Conditions

  • Contraception

Interventions

PROCEDURE

Vasectomy occlusion techniques

Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • FHI 360

    lead OTHER

Principal Investigators

  • Chander Shekhar, MD · ICMR

  • David C. Sokal, MD · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00612833 on ClinicalTrials.gov