A Randomized Controlled Trial of Three Vasectomy Techniques

Not Applicable

Terminated

• Conditions: Contraception
• Interventions: Procedure: Vasectomy occlusion techniques

• Registration Number: NCT00612833
• Lead Sponsor: FHI 360

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-02-12
• Study Start: 2009-01
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Vasectomy occlusion techniques	Cautery and excision without fascial interposition
cautery excision with fascial interposition	Vasectomy occlusion techniques	Contraception using cautery and excision with fascial interposition
C	Vasectomy occlusion techniques	Ligation and excision with fascial interposition

Primary Outcome Measures

Name	Time	Method
Sperm concentration in semen	12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety	up to 12 months

Trial Locations

Locations (5)

St. Stephens Hospital; 🇮🇳 New Delhi, Delhi, India

Maulana Azad Medical College; 🇮🇳 New Delhi, Delhi, India

Post Graduate Institute of Medical Sciences; 🇮🇳 Rohtak, Haryana, India

Civil Hospital,; 🇮🇳 Amritsar, Punjab, India

E. S.T.N.M. Hospital, Gangtok; 🇮🇳 Gangtok, Sikkim, India