A Randomized Controlled Trial of Three Vasectomy Techniques
NCT ID: NCT00612833
Last Updated: 2013-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
INTERVENTIONAL
2009-01-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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cautery excision with fascial interposition
Contraception using cautery and excision with fascial interposition
Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
B
Cautery and excision without fascial interposition
Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
C
Ligation and excision with fascial interposition
Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
Interventions
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Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
Eligibility Criteria
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Inclusion Criteria
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
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)
21 Years
MALE
No
Sponsors
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Indian Council of Medical Research
OTHER_GOV
FHI 360
OTHER
Responsible Party
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Principal Investigators
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Chander Shekhar, MD
Role: PRINCIPAL_INVESTIGATOR
ICMR
David C. Sokal, MD
Role: PRINCIPAL_INVESTIGATOR
FHI 360
Locations
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Post Graduate Institute of Medical Sciences
Rohtak, Haryana, India
Maulana Azad Medical College
New Delhi, National Capital Territory of Delhi, India
St. Stephens Hospital
New Delhi, National Capital Territory of Delhi, India
Civil Hospital,
Amritsar, Punjab, India
E. S.T.N.M. Hospital, Gangtok
Gangtok, Sikkim, India
Countries
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Related Links
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Related Info
Other Identifiers
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FHI-9980
Identifier Type: -
Identifier Source: org_study_id