A Randomized Controlled Trial of Three Vasectomy Techniques
Information source: FHI 360
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Vasectomy occlusion techniques (Procedure)
Phase: N/A
Status: Terminated
Sponsored by: FHI 360 Official(s) and/or principal investigator(s): Chander Shekhar, MD, Principal Investigator, Affiliation: ICMR David C. Sokal, MD, Principal Investigator, Affiliation: FHI 360
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.
Clinical Details
Official title: A Randomized Controlled Trial of Three Vasectomy Techniques
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Sperm concentration in semen
Secondary outcome: Safety
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
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Male.
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)
Locations and Contacts
Maulana Azad Medical College, New Delhi, Delhi 110 002, India
St. Stephens Hospital, New Delhi, Delhi 110 054, India
Post Graduate Institute of Medical Sciences, Rohtak, Haryana 124 001, India
Civil Hospital,, Amritsar, Punjab 143 001, India
E. S.T.N.M. Hospital, Gangtok, Gangtok, Sikkim 737 101, India
Additional Information
Starting date: January 2009
Last updated: September 9, 2013
|