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A Randomized Controlled Trial of Three Vasectomy Techniques

This study has been terminated.
(FHI 360 participation in the study was terminated due to lack of funding)
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT00612833
First received: January 29, 2008
Last updated: September 9, 2013
Last verified: September 2013

January 29, 2008
September 9, 2013
January 2009
Not Provided
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
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
Procedure: Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
  • Active Comparator: cautery excision with fascial interposition
    Contraception using cautery and excision with fascial interposition
    Intervention: Procedure: Vasectomy occlusion techniques
  • Active Comparator: B
    Cautery and excision without fascial interposition
    Intervention: Procedure: Vasectomy occlusion techniques
  • Active Comparator: C
    Ligation and excision with fascial interposition
    Intervention: Procedure: Vasectomy occlusion techniques
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
Not Provided
Not Provided

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 information is only displayed when the study is recruiting subjects
India
 
NCT00612833
FHI-9980
Yes
FHI 360
FHI 360
Indian Council of Medical Research
Principal Investigator: Chander Shekhar, MD ICMR
Principal Investigator: David C. Sokal, MD FHI 360
FHI 360
September 2013

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