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A Comparison of three vasectomy (male sterilisation) techniques

Not Applicable
Registration Number
CTRI/2011/04/001702
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
1500
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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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