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A Randomized Controlled Trial of Three Vasectomy Techniques

This study is not yet open for participant recruitment.
Verified by Family Health International, February 2008

Sponsors and Collaborators: Family Health International
Indian Council of Medical Research
Information provided by: Family Health International
ClinicalTrials.gov Identifier: NCT00612833
  Purpose

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.


Condition Intervention
The Relative Contraceptive Effectiveness of Three Methods of Occluding the Vas, in the Context of a no-Scalpel Vasectomy Procedure.
Procedure: Vasectomy occlusion techniques

MedlinePlus related topics:   Birth Control   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized Controlled Trial of Three Vasectomy Techniques

Further study details as provided by Family Health International:

Primary Outcome Measures:
  • Sperm concentration in semen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   1500
Study Start Date:   January 2008
Estimated Study Completion Date:   April 2011
Estimated Primary Completion Date:   April 2001 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator
Cautery and excision with fascial interposition
Procedure: Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
B: Active Comparator
Cautery and excision without fascial interposition
Procedure: Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
C: Active Comparator
Ligation and excision with fascial interposition
Procedure: Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition

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.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Freely consent to participate in the study and sign an Informed Consent Form
  2. Be at least 21 years old
  3. The couple should have at least one living child greater than one year of age
  4. With his partner be willing to use an alternate method of contraception until success is confirmed
  5. 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
  6. Be willing to submit semen samples collected by masturbation in the clinic according to the study follow-up schedule
  7. Be able to understand the procedures and study requirements

Exclusion Criteria:

  1. 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
  2. History of surgery involving the vas or testes (including previous vasectomy)
  3. Previous injury or significant abnormality of the scrotum
  4. Clinical evidence of an acute sexually transmitted infection; however a man may be admitted to the study after resolution of the acute condition.
  5. Local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, but a man may be admitted after resolution of an acute infection
  6. History of coagulation or other bleeding disorders
  7. Large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass
  8. Acute systemic infection (including gastroenteritis), but a man may be admitted after resolution of the condition
  9. Currently taking or planning to take any type of systemic medication which could affect sperm count (e.g. anabolic steroids)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612833

Contacts
Contact: David C. Sokal, MD     919-405-1466     dsokal@fhi.org    

Locations
India, Delhi
Maulana Azad Medical College     Not yet recruiting
      New Delhi, Delhi, India, 110 002
      Contact: R.C. M. Kaza, MD     +91 11 32440779     kaza62@rediffmail.com    
St. Stephens Hospital     Not yet recruiting
      New Delhi, Delhi, India, 110 054
      Contact: Manmohan Singh Grover, MD     +91 11 23966021 - 27     ssh@vsnl.com    
India, Haryana
Post Graduate Institute of Medical Sciences     Not yet recruiting
      Rohtak, Haryana, India, 124 001
      Contact: Sham Singla, MD     +91 1262 213883     drshamsingla@yahoo.com    
India, Punjab
Civil Hospital,     Not yet recruiting
      Amritsar, Punjab, India, 143 001
      Contact: Baljit Kaur, MD     +91 183 2211864     drbaljitkaur2000@yahoo.com    
India, Sikkim
E. S.T.N.M. Hospital, Gangtok     Not yet recruiting
      Gangtok, Sikkim, India, 737 101
      Contact: PASSANG D. PHEMPU, MD     +91 03592 202807     phempupd@yahoo.com    

Sponsors and Collaborators
Family Health International
Indian Council of Medical Research

Investigators
Principal Investigator:     Chander Shekhar, MD     ICMR    
Principal Investigator:     David C. Sokal, MD     Family Health International    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 
Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Family Health International ( David C. Sokal, MD / Scientist )
Study ID Numbers:   FHI-9980
First Received:   January 29, 2008
Last Updated:   February 15, 2008
ClinicalTrials.gov Identifier:   NCT00612833
Health Authority:   United States: Institutional Review Board;   India: Institutional Review Boards

Keywords provided by Family Health International:
Vasectomy  
male contraception  
contraceptive effectiveness  
semen analysis  
surgical techniques
fascial interposition
cautery

ClinicalTrials.gov processed this record on October 07, 2008




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