Abstract:
Objective: To introduce a method for increasing of vasovasostomy success rate.
Study plan: Randomized, single blind, controlled, without placebo, single centered.
Population: Males who will undergo vasectomy and will refer to Shohada-ye Tajrish medical center.
Inclusion criteria:
Males who will undergo vasectomy.
Exclusion criteria:
History of urethral or bladder neck surgery; History of previous vasovasostomy; History of scrotal region radiotherapy or chemotherapy; Age of partner out of fertility range.
Target sample size: 40
Interventions:
Intervention group: vasovasostomy with local intraoperative mitomycin 0.2 mg/dl for 5 minutes.
Control group: standard vasovasostomy without local intraoperative mitomycin and without placebo.
Duration of intervention: 6 months
Outcomes of study:
Presence of sperm in semen; Sperm count; Sperm motility rate; Normal morphology rate in sperms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092324166N1
Registration date:2016-12-12, 1395/09/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-12, 1395/09/22
Registrant information
Name
Hamidreza Qashqai
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 230 7789
Email address
qashqaee@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomised clinical trial for assessment of effects of local intraoperative mitomycin during vasovasostomy on sperm analysis results
Public title
Comparison of vasovasostomy outcomes with and without local intraoperative mitomycin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Males who undergo vasectomy.
Exclusion criteria:
History of urethral or bladder neck surgery; History of previous vasovasostomy; History of scrotal region radiotherapy or chemotherapy; Age of partner out of fertility range.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed by closed pockets method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of medical sciences
Street address
Shahid Beheshti university of medical sciences, Aarabi Av., Yaman st., Velenjak
City
Tehran
Postal code
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.SBMU.MSP.REC.1395.100
Health conditions studied
1
Description of health condition studied
Male Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility Incl.: Azoospermia NOS Oligospermia NOS
Primary outcomes
1
Description
Presence of sperm in semen
Timepoint
Six months after surgical procedure
Method of measurement
Semen analysis
2
Description
Sperm count
Timepoint
Six months after surgical procedure
Method of measurement
Semen analysis
3
Description
Sperm motility rate
Timepoint
Six months after surgical procedure
Method of measurement
Semen analysis
4
Description
Normal morphology rate in sperms
Timepoint
Six months after surgical procedure
Method of measurement
Semen analysis
Secondary outcomes
1
Description
Hematoma in operation site
Timepoint
1 month after procedure, 3 months after procedure and 6 months after procedure
Method of measurement
Physical examination
2
Description
Inflammatory reaction in surgical site
Timepoint
1 month after procedure, 3 months after procedure and 6 months after procedure
Method of measurement
Physical examination
3
Description
Tissue necrosis in surgical site
Timepoint
1 month after procedure, 3 months after procedure and 6 months after procedure
Method of measurement
Physical examination
4
Description
Failure of operation
Timepoint
1 month after procedure, 3 months after procedure and 6 months after procedure
Method of measurement
Sperm analysis
Intervention groups
1
Description
Inntervention group: vasovasostomy with local intraoperative mitomycin 0.2 mg/dl for 5 minutes
Category
Treatment - Surgery
2
Description
Control group: standard vasovasostomy without local intraoperative mitomycin and without placebo
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-e Tajrish Medical Center
Full name of responsible person
Dr. Farzad Allameh
Street address
Qods sq., Tajrish
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Aarabi Av., Yaman St., Velenjak,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Urology department
Full name of responsible person
Dr. Hamidreza Qashqai
Position
Urology Resident
Other areas of specialty/work
Street address
Shohada-e Tajrish Medical Center, Qods sq., Tajrish
City
Tehran
Postal code
Phone
+98 912 230 7789
Fax
Email
qashqaee@sbmu.ac.ir; qashqaee@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Urology department
Full name of responsible person
Dr. Farzad Allameh
Position
Urologist
Other areas of specialty/work
Street address
Shohada-e Tajrish Medical Center, Qods sq., Tajrish
City
Tehran
Postal code
Phone
+98 912 388 5545
Fax
Email
farzadallame@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Urology Department
Full name of responsible person
Dr. Hamidreza Qashqai
Position
Urology resident
Other areas of specialty/work
Street address
Shohada-e Tajrish Medical Center, Qods sq., Tajrish
City
Tehran
Postal code
1989934148
Phone
+98 912 230 7789
Fax
Email
qashqaee@sbmu.ac.ir; qashqaee@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)