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TerminatedNCT00612833Updated Sep 10, 2013

A Randomized Controlled Trial of Three Vasectomy Techniques

An interventional study of Vasectomy occlusion techniques in Contraception, sponsored by FHI 360. Terminated at 5 sites in India. Open to male participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-09-10.

Sponsored by FHI 360 · Not applicable, Interventional, and Prevention

Why this study was terminated
FHI 360 participation in the study was terminated due to lack of funding
Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
21 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Contraception

Keywords

  • 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.
03

In context

Lead sponsor

FHI 360 is the lead sponsor of 59 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Study arms

  • Active comparator
    cautery excision with fascial interposition

    Contraception using cautery and excision with fascial interposition

    Procedure: Vasectomy occlusion techniques

  • Active comparator
    B

    Cautery and excision without fascial interposition

    Procedure: Vasectomy occlusion techniques

  • Active comparator
    C

    Ligation and excision with fascial interposition

    Procedure: Vasectomy occlusion techniques

Interventions

  • ProcedureVasectomy occlusion techniques

    Cautery and excision with fascial interposition Cautery and excision without fascial interposition Ligation and excision with fascial interposition

06

What researchers measure

Primary outcomes

  1. Sperm concentration in semen

    Time frame: 12 weeks

Secondary outcomes

  1. Safety

    Time frame: up to 12 months

07

Study locations

5 sites
  • Post Graduate Institute of Medical Sciences
    Rohtak, Haryana 124 001, India
  • Maulana Azad Medical College
    New Delhi, National Capital Territory of Delhi 110 002, India
  • St. Stephens Hospital
    New Delhi, National Capital Territory of Delhi 110 054, India
  • Civil Hospital,
    Amritsar, Punjab 143 001, India
  • E. S.T.N.M. Hospital, Gangtok
    Gangtok, Sikkim 737 101, India
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00612833
Lead sponsor
FHI 360
Collaborators
Indian Council of Medical Research
Responsible party
Sponsor
First posted
Feb 12, 2008
Start date
Jan 2009
Last update
Sep 10, 2013

Study contacts

Chander Shekhar, MD
principal investigator · ICMR
David C. Sokal, MD
principal investigator · FHI 360

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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