A Randomized Controlled Trial of Three Vasectomy Techniques

This study has been terminated.
(FHI 360 participation in the study was terminated due to lack of funding)
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT00612833
First received: January 29, 2008
Last updated: September 9, 2013
Last verified: September 2013
  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:

  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.


Condition Intervention
Contraception
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:


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 ]

Study Start Date: January 2009
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
Maulana Azad Medical College
New Delhi, Delhi, India, 110 002
St. Stephens Hospital
New Delhi, Delhi, India, 110 054
Post Graduate Institute of Medical Sciences
Rohtak, Haryana, India, 124 001
Civil Hospital,
Amritsar, Punjab, India, 143 001
E. S.T.N.M. Hospital, Gangtok
Gangtok, Sikkim, India, 737 101
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:
No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT00612833     History of Changes
Other Study ID Numbers: FHI-9980
Study First Received: January 29, 2008
Last Updated: September 9, 2013
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 August 28, 2014