Status:
TERMINATED
A Randomized Controlled Trial of Three Vasectomy Techniques
Lead Sponsor:
FHI 360
Collaborating Sponsors:
Indian Council of Medical Research
Conditions:
Contraception
Eligibility:
MALE
21+ years
Phase:
NA
Brief 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 vasectom...
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 vasectom...
Eligibility Criteria
Inclusion
- Freely consent to participate in the study and sign an informed consent form
- Be at least 21 years old
- The couple should have at least one living child greater than one year of age
- With his partner be willing to use an alternate method of contraception until success is confirmed
- 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
- Be willing to submit semen samples collected by masturbation in the clinic according to the study follow-up schedule
- Be able to understand the procedures and study requirements
Exclusion
- 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
- History of surgery involving the vas or testes (including previous vasectomy)
- Previous injury or significant abnormality of the scrotum
- Clinical evidence of an acute sexually transmitted infection; however a man may be admitted to the study after resolution of the acute condition.
- Local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, but a man may be admitted after resolution of an acute infection
- History of coagulation or other bleeding disorders
- Large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass
- Acute systemic infection (including gastroenteritis), but a man may be admitted after resolution of the condition
- Currently taking or planning to take any type of systemic medication which could affect sperm count (e.g. anabolic steroids)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00612833
Start Date
January 1 2009
Last Update
September 10 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Post Graduate Institute of Medical Sciences
Rohtak, Haryana, India, 124 001
2
Maulana Azad Medical College
New Delhi, National Capital Territory of Delhi, India, 110 002
3
St. Stephens Hospital
New Delhi, National Capital Territory of Delhi, India, 110 054
4
Civil Hospital,
Amritsar, Punjab, India, 143 001