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Clinical Trials/CTRI/2011/04/001702
CTRI/2011/04/001702Recruiting未知

A Randomized Controlled Trial of Three Vasectomy Techniques

Indian Council of Medical Research0 sites1,500 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
未知
Status
Recruiting
Enrollment
1,500

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility 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 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 gastroenterits), 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)

Investigators

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