A Randomized Controlled Trial of Three Vasectomy Techniques - Full Text View

Sponsor:	FHI 360
Collaborator:	Indian Council of Medical Research
Information provided by:	FHI 360
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:

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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control Vasectomy

U.S. FDA Resources

Further study details as provided by FHI 360:

Primary Outcome Measures:

Sperm concentration in semen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612833

Contacts

Contact: David C. Sokal, MD

919-405-1466

dsokal@fhi.org

Locations

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

Sponsors and Collaborators

FHI 360

Indian Council of Medical Research

Investigators

Principal Investigator:	Chander Shekhar, MD	ICMR
Principal Investigator:	David C. Sokal, MD	FHI 360

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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 February 13, 2012