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| Sponsors and Collaborators: |
Family Health International Indian Council of Medical Research |
|---|---|
| Information provided by: | Family Health International |
| ClinicalTrials.gov Identifier: | NCT00612833 |
Purpose
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:
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.
| Condition | Intervention |
|---|---|
|
Compare 3 Vasectomy Techniques |
Procedure: Vasectomy occlusion techniques |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Controlled Trial of Three Vasectomy Techniques |
| Estimated Enrollment: | 1500 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Cautery and excision with fascial interposition
|
Procedure: Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
|
|
B: Active Comparator
Cautery and excision without fascial interposition
|
Procedure: Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
|
|
C: Active Comparator
Ligation and excision with fascial interposition
|
Procedure: Vasectomy occlusion techniques
Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition
|
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:
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| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David C. Sokal, MD | 919-405-1466 | dsokal@fhi.org |
| India, Delhi | |
| Maulana Azad Medical College | |
| New Delhi, Delhi, India, 110 002 | |
| St. Stephens Hospital | |
| New Delhi, Delhi, India, 110 054 | |
| India, Haryana | |
| Post Graduate Institute of Medical Sciences | |
| Rohtak, Haryana, India, 124 001 | |
| India, Punjab | |
| Civil Hospital, | |
| Amritsar, Punjab, India, 143 001 | |
| India, Sikkim | |
| E. S.T.N.M. Hospital, Gangtok | |
| Gangtok, Sikkim, India, 737 101 | |
| Principal Investigator: | Chander Shekhar, MD | ICMR |
| Principal Investigator: | David C. Sokal, MD | Family Health International |
More Information
| Responsible Party: | Family Health International ( David C. Sokal, MD / Scientist ) |
| Study ID Numbers: | FHI-9980 |
| Study First Received: | January 29, 2008 |
| Last Updated: | January 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00612833 History of Changes |
| Health Authority: | United States: Institutional Review Board; India: Institutional Review Board |
|
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. |
|
Contraceptive Agents |