Clinical trial NCT00612833: A Randomized Controlled Trial of Three Vasectomy Techniques
Official title: A Randomized Controlled Trial of Three Vasectomy Techniques
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contraception
Keywords: 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.
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
First posted: 2008-02-12
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Sperm concentration in semen
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety
timeFrame: up to 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Maulana Azad Medical College
state: Delhi
city: New Delhi
country: India
facility: St. Stephens Hospital
state: Delhi
city: Rohtak
country: India
facility: Post Graduate Institute of Medical Sciences
state: Haryana
city: Amritsar
country: India
facility: Civil Hospital,
state: Punjab
city: Gangtok
country: India
facility: E. S.T.N.M. Hospital, Gangtok
state: Sikkim
Study officials:
affiliation: ICMR
name: Chander Shekhar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FHI 360
name: David C. Sokal, MD
role: PRINCIPAL_INVESTIGATOR
References: