CTRI/2011/04/001702Recruiting未知
A Randomized Controlled Trial of Three Vasectomy Techniques
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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