A Randomized Controlled Trial of Three Vasectomy Techniques

Study Overview
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Brief Summary
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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: ligation and excision of about 1 cm of the vas, with fascial interposition; intraluminal thermal cautery with excision of about 1 cm of the vas; 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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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: ligation and excision of about 1 cm of the vas, with fascial interposition; intraluminal thermal cautery with excision of about 1 cm of the vas; and, 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.

Official Title
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A Randomized Controlled Trial of Three Vasectomy Techniques

Conditions
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Contraception

Intervention / Treatment
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* Procedure: Vasectomy occlusion techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cautery excision with fascial interposition<br>Contraception using cautery and excision with fascial interposition | Procedure: Vasectomy occlusion techniques<br>* Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition<br>|
| Active Comparator: B<br>Cautery and excision without fascial interposition | Procedure: Vasectomy occlusion techniques<br>* Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition<br>|
| Active Comparator: C<br>Ligation and excision with fascial interposition | Procedure: Vasectomy occlusion techniques<br>* Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm concentration in semen |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasectomy, Male contraception, Contraceptive effectiveness, Semen analysis, Surgical techniques, Fascial interposition, Cautery, The relative contraceptive effectiveness of three methods of occluding the vas, in the context of a no-scalpel vasectomy procedure.