A Randomized Controlled Trial of Three Vasectomy Techniques

Contraception Clinical Trial

Official title:

A Randomized Controlled Trial of Three Vasectomy Techniques

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00612833
• Other study ID #: FHI-9980
• Status: Terminated
• Phase: N/A
• First received: January 29, 2008
• Last updated: September 9, 2013
• Start date: January 2009

Study information

• Verified date: September 2013
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Procedure:
• Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition

Locations

Country	Name	City	State
India	Civil Hospital,	Amritsar	Punjab
India	E. S.T.N.M. Hospital, Gangtok	Gangtok	Sikkim
India	Maulana Azad Medical College	New Delhi	Delhi
India	St. Stephens Hospital	New Delhi	Delhi
India	Post Graduate Institute of Medical Sciences	Rohtak	Haryana

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	Indian Council of Medical Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm concentration in semen		12 weeks	No
Secondary	Safety		up to 12 months	Yes

External Links

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