This study was performed to determine the effect of Co-enzyme Q10 (CoQ10) on sperm parameters in patients with varicocele after varicocelectomy. This is a randomized, triple blind, control trial among 50 patients. Fifty cases of varicocele after varicocelectomy were divided into Co-Q10 (n = 25) and placebo groups (n = 25), the former given oral CoQ10 at 100mg daily and the latter given placebo in the same shape, color, size and dosage of the used CoQ10 for 6 months. Comparisons were made between the two groups in the semen volume, sperm motility, sperm morphology and sperm count. Inclusion criteria were candidacy for varicocelectomy and exclusion criteria were positive history for surgery on genitourinary system, positive history for genitourinary infection, azoospermia and appearance of varicocelectomy complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110034181N7
Registration date:2011-10-26, 1390/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-26, 1390/08/04
Registrant information
Name
Yadollah Ahmadi AsrBadr
Name of organization / entity
Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1924
Email address
ahmadiy@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of medical sceinces
Expected recruitment start date
2010-03-19, 1388/12/28
Expected recruitment end date
2011-02-25, 1389/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment outcome of Co-enzyme Q10 (CoQ10) following varicocelectomy
Public title
Treatment outcome of Co-enzyme Q10 on infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidacy for varicocelectomy. Exclusion criteria: positive history for varicocelectomy or other gentourinary surgery of any kind; positive history for genitourinary infection; azoospermia; appearance of varicocelectomy complications; use of drugs in the last 3 months; smoking in the last 6 months; alchohol consumption in the last 6 months.
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tabriz university of medical sciences
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Postal code
51665118
Approval date
2011-10-19, 1390/07/27
Ethics committee reference number
9039
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
male infertility
Primary outcomes
1
Description
sperm count
Timepoint
6 months
Method of measurement
microscope
2
Description
sperm motility
Timepoint
6 months
Method of measurement
microscope
3
Description
semen volume
Timepoint
6 months
Method of measurement
volumeter
4
Description
sperm morphology
Timepoint
6 months
Method of measurement
microscope
Secondary outcomes
empty
Intervention groups
1
Description
Oral Co-enzyme Q10 100mg/OD, for 6 months
Category
Treatment - Drugs
2
Description
Oral placebo/OD for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
clinics of Tabriz university of medical sciences
Full name of responsible person
Yadollah Ahmadi Asr Badr (urologist, assistant professor)
Street address
clinics of Sina hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Tabriz university of medical siences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz university of medical sciences
Full name of responsible person
Mehdi Hemmati
Position
Intern
Other areas of specialty/work
Street address
No. 57, Azimi alley, North Tavanir, Abbasi street
City
Tabriz
Postal code
5155737551
Phone
+98 41 1658 4305
Fax
Email
hemmati.mehdi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mehdi Hemmati
Position
Intern
Other areas of specialty/work
Street address
No. 57, Azimi alley, North Tavanir, Abbasi street
City
Tabriz
Postal code
5155737551
Phone
+98 41 1658 4305
Fax
Email
hemmati.mehdi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mehdi Hemmati
Position
Intern
Other areas of specialty/work
Street address
No. 57, Azimi alley, North Tavanir, Abbasi street
City
Tabriz
Postal code
5155737551
Phone
+98 41 1658 4305
Fax
Email
hemmati.mehdi@gmail.com , ahmadiy@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)