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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00612833
Other study ID # FHI-9980
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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