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Comparison of vasovasostomy outcomes with and without local intraoperative mitomycin

Randomised clinical trial for assessment of effects of local intraoperative mitomycin during vasovasostomy on sperm analysis results

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015092324166N1
Enrollment
40
Registered
2016-12-12
Start date
2016-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility. Male infertility Incl.: Azoospermia NOS Oligospermia NOS

Interventions

Intervention 1: Inntervention group: vasovasostomy with local intraoperative mitomycin 0.2 mg/dl for 5 minutes. Intervention 2: Control group: standard vasovasostomy without local intraoperative mitom
Treatment - Surgery
Inntervention group: vasovasostomy with local intraoperative mitomycin 0.2 mg/dl for 5 minutes
Control group: standard vasovasostomy without local intraoperative mitomycin and without placebo

Sponsors

Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Presence of sperm in semen. Timepoint: Six months after surgical procedure. Method of measurement: Semen analysis.;Sperm count. Timepoint: Six months after surgical procedure. Method of measurement: Semen analysis.;Sperm motility rate. Timepoint: Six months after surgical procedure. Method of measurement: Semen analysis.;Normal morphology rate in sperms. Timepoint: Six months after surgical procedure. Method of measurement: Semen analysis.

Secondary

MeasureTime frame
Hematoma in operation site. Timepoint: 1 month after procedure, 3 months after procedure and 6 months after procedure. Method of measurement: Physical examination.;Inflammatory reaction in surgical site. Timepoint: 1 month after procedure, 3 months after procedure and 6 months after procedure. Method of measurement: Physical examination.;Tissue necrosis in surgical site. Timepoint: 1 month after procedure, 3 months after procedure and 6 months after procedure. Method of measurement: Physical examination.;Failure of operation. Timepoint: 1 month after procedure, 3 months after procedure and 6 months after procedure. Method of measurement: Sperm analysis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hamidreza Qashqai

Shahid Beheshti University of Medical Sciences, Urology department

qashqaee@sbmu.ac.ir; qashqaee@gmail.com+98 912 230 7789

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 20, 2026