To determine and comparison of the amount of sperm DFI before and after treatment in the study group
Design
Clinical trial ( before and after )study, without control group and not blinded ,single ,available sampling on 60 patients
Settings and conduct
The location of the studey is the infertility center and urology clinic of Ali-Ibn Abitaleb Hospital in Zahedan.
Before starting treatment, sperm DFI test is performed and then patients are treated with Sperigen drug for 3 months.At the end of therapeutic intervention, the DFI test is taken from the patients again.
The test is performed on the patient's semen.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Infertile men with impaired spermogram (Idiopathic
spermogram)
2) age range 20 to 40 years
3)No hormonal disorder, anatomical or congenital anomalies
in urogenital system
4) Lack of antioxidant medication usage and drugs affecting
spermogran parmeters such as nitrofurantoin, corticosteroids,
antineoplastic drug
Exclusion criteria:
1)men with normal spermogram
2) drug use, cigarrette or waterpipe smoking
3)outside the specified age range
4)varicocele
5)patients with diabetes, thyroid problems and other internal
disease affeting spermogram
Intervention groups
before starting the treatment ,sperm DFI test will be done and the patients will be treated with Sperigen drug for three months. At the end of the therapeutic intervention, the DFI test will be taken from the patient again.After analyzing the findings, the values obtained before and after taking the drug are compared and the effecriveness of the drug is determined on the amount of DFI.
Main outcome variables
Total sperm count; Total motile sperm count; Sperm morphology; DNA fragmentation Index
General information
Reason for update
Acronym
DFI(DNA Fragmentation Index)
IRCT registration information
IRCT registration number:IRCT20230831059309N1
Registration date:2023-10-23, 1402/08/01
Registration timing:prospective
Last update:2023-10-23, 1402/08/01
Update count:0
Registration date
2023-10-23, 1402/08/01
Registrant information
Name
narges ghaznavi jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 1897
Email address
n.ghaznavi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of compund antioxidant medication (Sperigen tablet) on sperm DNA Fragmentation Index in infertile men aged 20 to 40 years of age
Public title
Effect of compund antioxidant medication (Sperigen tablet) on sperm DNA Fragmentation Index in infertile men aged 20 to 40 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile men with abnormal spermogram (Idiopathic)
age range 20 to 40 years
absence of hormonal, anatomical and congenital anomalies of the urogenital system,
lack of antioxidant medication usage or drugs affecting spermogram parameters such as nitrofurantoin, corticosteroids and antineoplastic.
Exclusion criteria:
Men with normal spermogram
use of drugs, cigarrette and waterpipe smoking
patients outside the specified age range
varicocele
patients with Diabete, thyroid problem or any other internal disease affectting spermogram
Age
From 20 years old to 40 years old
Gender
Male
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Urology department office,Ali-Ibn Abitaleb Hospital,Khalij Fars Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
IR.ZAUMS.REC.1402.257
Health conditions studied
1
Description of health condition studied
male infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
percentage of sperm DFI , total sperm count and total motile sperm in semen analysis.
Timepoint
Measurement of DNA fragmentation Index before starting and 3 months after taking the drug
Method of measurement
Sperm Chromatin Structure Assay lab test (SCSA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:patients treated with Sperigen drug (manufactured by Arvand Pharmed Company) one oral capsule every 12 hours for three months.This medicine contains of a variety of antioxidants such as vitamin C, vitamin B group, vitamin A, zinc, iron, folic acid, selenium, niacin, biotin and...
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center and Urology clinic of Ali-Ibn Abitaleb Zahedan Hospital
Full name of responsible person
Faramarz Fazali
Street address
Khalij Fars Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
n.ghaznavi@zaums.ac.ir
Web page address
http://alihos.zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
سودابه هاشم زهی
Street address
Zahedan University of medical science, headquarters building,ِDr Hesabi Square,Khalij Fars Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2113
Fax
+98 54 3337 2151
Email
soodi1981@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Narges Ghaznavi Jahromi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 252, Alley 2/3, Sheikhi St., South Iman Blvd
City
Shiraz
Province
Fars
Postal code
7185999349
Phone
+98 71 3233 1897
Email
n.ghaznavi@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Faramarz Fazeli
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Urology department office,Ali-Ibn Abitaleb Hospital,Khalij Fars Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 917 141 5395
Email
n.ghaznavi@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Narges Ghaznavi Jahromi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 252, Alley 2/3, Sheikhi St., South Iman Blvd
City
Shiraz
Province
Fars
Postal code
7185999349
Phone
+98 71 3233 1897
Email
n.ghaznavi@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available