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A Randomized Controlled Trial of Three Vasectomy Techniques
This study is not yet open for participant recruitment.
Study NCT00612833   Information provided by Family Health International
First Received: January 29, 2008   Last Updated: January 14, 2009   History of Changes

January 29, 2008
January 14, 2009
January 2009
July 2011   (final data collection date for primary outcome measure)
Sperm concentration in semen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00612833 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Same as current
 
A Randomized Controlled Trial of Three Vasectomy Techniques
A Randomized Controlled Trial of Three Vasectomy Techniques

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.

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.

 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Compare 3 Vasectomy Techniques
Procedure: Vasectomy occlusion techniques
  • Active Comparator: Cautery and excision with fascial interposition
  • Active Comparator: Cautery and excision without fascial interposition
  • Active Comparator: Ligation and excision with fascial interposition
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
1500
December 2011
July 2011   (final data collection date for primary outcome measure)

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)
Male
21 Years and older
No
Contact: David C. Sokal, MD 919-405-1466 dsokal@fhi.org
India
 
NCT00612833
David C. Sokal, MD / Scientist, Family Health International
FHI-9980
Family Health International
Indian Council of Medical Research
Principal Investigator: Chander Shekhar, MD ICMR
Principal Investigator: David C. Sokal, MD Family Health International
Family Health International
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP