A Randomized Controlled Trial of Three Vasectomy Techniques
Recruitment status was Recruiting
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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:
- ligation and excision of about 1 cm of the vas, with fascial interposition;
- intraluminal thermal cautery with excision of about 1 cm of the vas;
- 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.
| Condition | Intervention |
|---|---|
|
Compare 3 Vasectomy Techniques |
Procedure: Vasectomy occlusion techniques |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized Controlled Trial of Three Vasectomy Techniques |
- Sperm concentration in semen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Safety [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Active Comparator: A
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
|
|
Active Comparator: B
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
|
|
Active Comparator: C
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
|
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:
- ligation and excision of about 1 cm of the vas, with fascial interposition;
- intraluminal thermal cautery with excision of about 1 cm of the vas; and,
- 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| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Freely consent to participate in the study and sign an informed consent form
- Be at least 21 years old
- The couple should have at least one living child greater than one year of age
- With his partner be willing to use an alternate method of contraception until success is confirmed
- 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
- Be willing to submit semen samples collected by masturbation in the clinic according to the study follow-up schedule
- Be able to understand the procedures and study requirements
Exclusion Criteria:
- 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
- History of surgery involving the vas or testes (including previous vasectomy)
- Previous injury or significant abnormality of the scrotum
- Clinical evidence of an acute sexually transmitted infection; however a man may be admitted to the study after resolution of the acute condition.
- Local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, but a man may be admitted after resolution of an acute infection
- History of coagulation or other bleeding disorders
- Large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass
- Acute systemic infection (including gastroenteritis), but a man may be admitted after resolution of the condition
- Currently taking or planning to take any type of systemic medication which could affect sperm count (e.g. anabolic steroids)
Contacts and Locations| Contact: David C. Sokal, MD | 919-405-1466 | dsokal@fhi.org |
| India | |
| Maulana Azad Medical College | Recruiting |
| New Delhi, Delhi, India, 110 002 | |
| Contact: R.C. M. Kaza, MD +91 11 32440779 kaza62@rediffmail.com | |
| St. Stephens Hospital | Recruiting |
| New Delhi, Delhi, India, 110 054 | |
| Contact: Manmohan Singh Grover, MD +91 11 23966021 - 27 ssh@vsnl.com | |
| Post Graduate Institute of Medical Sciences | Recruiting |
| Rohtak, Haryana, India, 124 001 | |
| Contact: Sham Singla, MD +91 1262 213883 drshamsingla@yahoo.com | |
| Civil Hospital, | Recruiting |
| Amritsar, Punjab, India, 143 001 | |
| Contact: Baljit Kaur, MD +91 183 2211864 drbaljitkaur2000@yahoo.com | |
| E. S.T.N.M. Hospital, Gangtok | Recruiting |
| Gangtok, Sikkim, India, 737 101 | |
| Contact: Passang D. Phempu, MD +91 03592 202807 phempupd@yahoo.com | |
| Principal Investigator: | Chander Shekhar, MD | ICMR |
| Principal Investigator: | David C. Sokal, MD | FHI 360 |
More Information
Additional Information:
No publications provided
| Responsible Party: | David C. Sokal, MD / Scientist, Family Health International |
| ClinicalTrials.gov Identifier: | NCT00612833 History of Changes |
| Other Study ID Numbers: | FHI-9980 |
| Study First Received: | January 29, 2008 |
| Last Updated: | June 25, 2010 |
| Health Authority: | United States: Institutional Review Board India: Institutional Review Board |
Keywords provided by FHI 360:
|
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. |
ClinicalTrials.gov processed this record on June 18, 2013