A Randomized Controlled Trial of Three Vasectomy Techniques

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.

Study Overview

• Status: Terminated
• Conditions: Contraception
• Intervention / Treatment: Procedure: Vasectomy occlusion techniques

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110 002
      • Maulana Azad Medical College
    • New Delhi, Delhi, India, 110 054
      • St. Stephens Hospital
  • Haryana
    • Rohtak, Haryana, India, 124 001
      • Post Graduate Institute of Medical Sciences
  • Punjab
    • Amritsar, Punjab, India, 143 001
      • Civil Hospital,
  • Sikkim
    • Gangtok, Sikkim, India, 737 101
      • E. S.T.N.M. Hospital, Gangtok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cautery excision with fascial interposition; Contraception using 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sperm concentration in semen	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety	up to 12 months

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Indian Council of Medical Research
• Investigators: Principal Investigator: Chander Shekhar, MD, ICMR; Principal Investigator: David C. Sokal, MD, FHI 360

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2009

Study Registration Dates

• First Submitted: January 29, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): February 12, 2008

Study Record Updates

• Last Update Posted (Estimate): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 9, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Male contraception; Semen analysis; Vasectomy; Surgical techniques; Contraceptive effectiveness; Fascial interposition; Cautery; The relative contraceptive effectiveness of three methods of occluding the vas, in the context of a no-scalpel vasectomy procedure.
• Other Study ID Numbers: FHI-9980