NCT00612833

Brief 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. 1.ligation and excision of about 1 cm of the vas, with fascial interposition;
  2. 2.intraluminal thermal cautery with excision of about 1 cm of the vas;
  3. 3.intraluminal thermal cautery with excision of about 1 cm of the vas combined with fascial interposition.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

First QC Date

January 29, 2008

Last Update Submit

September 9, 2013

Conditions

Contraception

Keywords

VasectomyMale contraceptionContraceptive effectivenessSemen analysisSurgical techniquesFascial interpositionCauteryThe relative contraceptive effectiveness of three methods of occluding the vas, in the context of a no-scalpel vasectomy procedure.

Outcome Measures

Primary Outcomes (1)

  • Sperm concentration in semen

    12 weeks

Secondary Outcomes (1)

  • Safety

    up to 12 months

Study Arms (3)

cautery excision with fascial interposition

ACTIVE COMPARATOR

Contraception using cautery and excision with fascial interposition

Procedure: Vasectomy occlusion techniques

B

ACTIVE COMPARATOR

Cautery and excision without fascial interposition

Procedure: Vasectomy occlusion techniques

C

ACTIVE COMPARATOR

Ligation and excision with fascial interposition

Procedure: Vasectomy occlusion techniques

Interventions

Vasectomy occlusion techniquesPROCEDURE

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

BCcautery excision with fascial interposition

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Freely consent to participate in the study and sign an informed consent form
  • Be at least 21 years old
  • The couple should have at least one living child greater than one year of age
  • With his partner be willing to use an alternate method of contraception until success is confirmed
  • Be willing to return for follow-up visits at 1, 8, 12 and 52 weeks post-vasectomy, and at 16, 20 and 24 weeks if needed
  • Be willing to submit semen samples collected by masturbation in the clinic according to the study follow-up schedule
  • Be able to understand the procedures and study requirements

You may not qualify if:

  • Has a condition that in the opinion of the investigator permanently or temporarily contraindicates participation in the study, e.g., depression or poorly-controlled diabetes
  • History of surgery involving the vas or testes (including previous vasectomy)
  • Previous injury or significant abnormality of the scrotum
  • Clinical evidence of an acute sexually transmitted infection; however a man may be admitted to the study after resolution of the acute condition.
  • Local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, but a man may be admitted after resolution of an acute infection
  • History of coagulation or other bleeding disorders
  • Large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass
  • Acute systemic infection (including gastroenteritis), but a man may be admitted after resolution of the condition
  • Currently taking or planning to take any type of systemic medication which could affect sperm count (e.g. anabolic steroids)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Post Graduate Institute of Medical Sciences

Rohtak, Haryana, 124 001, India

Location

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, 110 002, India

Location

St. Stephens Hospital

New Delhi, National Capital Territory of Delhi, 110 054, India

Location

Civil Hospital,

Amritsar, Punjab, 143 001, India

Location

E. S.T.N.M. Hospital, Gangtok

Gangtok, Sikkim, 737 101, India

Location

Related Links

Study Officials

  • Chander Shekhar, MD

    ICMR

    PRINCIPAL INVESTIGATOR

  • David C. Sokal, MD

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 12, 2008

Study Start

January 1, 2009

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

IN(5)