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The effect of adjuvant oral vitamin C therapy after varicocele surgery for improvement in sperm formation in infertile men

Protocol summary

Summary
In this randomized double blind clinical trial, the effect of adjuvant treatment of vitamin C on improvement in spermatogenesis after varicocele surgery is evaluated. All men with infertility and varicocele who attend Vali Asr Hospital of Arak or the private clinics of the executives of the study will be examined. In case of palpable varicocele in physical examination and accompanying abnormality in count, motility, or morphology of sperms in two separate semen analyses, they become candidates for surgery. Patients aged 18 to 50 who do not have azoospermia, underlying diseases, addiction to tobacco or opioids, active or chronic genito-urinary tract infections, history of peptic ulcer, or previous reaction to vitamin C will be recruited in our study. Those who do not consent to continue the study, do not come back for follow up visits, demonstrate side effects due to vitamin C, or become afflicted with late complications such as hydrocele, recurrence of varicocele, or testis atrophy will be excluded from the study. After surgery, patients are randomly divided into two groups and group one or the controls receive capsules filled with starch as placebo and group 2 receive capsules containing 500 mg of vitamin C in two daily doses. Three months after the surgery 2 separate semen analyses will be performed and the results before and after the surgery in regards to sperm count, motility, and morphology in the two groups are recorded and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201103042134N2
Registration date: 2011-12-27, 1390/10/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-27, 1390/10/06
Registrant information
Name
Ali Cyrus
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1888 1041
Email address
cyrus@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2010-02-20, 1388/12/01
Expected recruitment end date
2011-05-04, 1390/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adjuvant oral vitamin C therapy after varicocele surgery for improvement in sperm formation in infertile men
Public title
The effect of adjuvant vitamin C after varicocele surgery for improvement in sperm formation in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Palpable varicocele (grade 2 or 3) in physical examination; Abnormality in count, motility, or morphology of sperm in two separate semen analyses based on WHO criteria; No azoospermia; No major underlying disease such as: diabetes or hormonal abnormalities based on history and physical examination; Not smoker or addicted to any recreational drugs; Not using any drugs or supplements on a regular basis; Age between 18-50 years; Weight between 50-100 kg; No active or chronic genitourinary infection based on history, physical examination, urine analysis, and semen analysis; No previous history of peptic ulcer disease or vitamin C intolerance Exclusion criteria: Patients' unwillingness to continue participation; Not attending follow up visits; Incorrect utilization of the capsules; Occurrence of side effects due to capsules; Late complications of surgery such as hydrocele, recurrence of varicocele, or testis atrophy; Commencement of smoking or addiction during the follow up
Age
From 18 years old to 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Pardis Complex, Basij Square, Enghelab Square, Taleghani Ave
City
Arak
Postal code
Approval date
2010-02-20, 1388/12/01
Ethics committee reference number
88-71-6

Health conditions studied

1

Description of health condition studied
Varicocele
ICD-10 code
186.1
ICD-10 code description
Scrotal varices

2

Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
Sperm motility
Timepoint
Before and 3 months after the surgery
Method of measurement
Mean percent of motile sperm class A+B in two separate semen analyses

2

Description
Sperm count
Timepoint
Before and 3 months after the surgery
Method of measurement
Mean concentration of sperm in two separate semen analyses

3

Description
Sperm morphology
Timepoint
Before and 3 months after the surgery
Method of measurement
Mean percent of sperm with normal morphology based on WHO criteria in two separate semen analyses

Secondary outcomes

1

Description
Side effects
Timepoint
During the 3-month period of follow up
Method of measurement
Bases on patients' report on monthly visits

Intervention groups

1

Description
The control group receives two daily doses of starch-filled capsules as placebo, for 3 months after the surgery.
Category
Placebo

2

Description
The control group receives two daily doses of capsules filled with 500 mg of vitamin C (Osveh pharmaceuticals- Ref No. 1228038410) for 3 months after the surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Vali Asr Hospital
Full name of responsible person
Dr. Ali Cyrus
Street address
Department of Surgery, Vali-Asr Hospital, Vali-Asr Square
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr. Saeed Changizie Ashtiani
Street address
Pardis Complex, Basij Square, Enghelab Square, Taleghani Ave
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Cyrus
Position
Urologist/Associate professor
Other areas of specialty/work
Street address
Department of Surgery, Vali-Asr Hospital, Vali-Asr Square
City
Arak
Postal code
Phone
+98 86 1222 1041
Fax
Email
cyrus@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Cyrus
Position
Urologist/Associate professor
Other areas of specialty/work
Street address
Department of Surgery, Vali-Asr Hospital, Vali-Asr Square
City
Arak
Postal code
Phone
+98 86 1888 1041
Fax
Email
cyrus@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Cyrus
Position
Urologist/Associate professor
Other areas of specialty/work
Street address
Department of Surgery, Vali-Asr Hospital, Vali-Asr Square
City
Arak
Postal code
Phone
+98 86 1888 1041
Fax
Email
cyrus@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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