Evaluation of the effects of N-Acetyl cysteine on sperm parameters, biochemical-hormonal factors,c hromatin integrity and NRF2 ,HSPA2genes expression in the terato-astenozoospermic men.
Evaluation of the effects of N-Acetyl cysteine on sperm parameters, biochemical-hormonal factors,c hromatin integrity and NRF2 ,HSPA2genes expression in the terato-astenozoospermic men.
Design
This study was designed based on a clinical trial in which patients and researchers are aware of the type of treatment. Individuals in the NAC group (daily treatment group) receive three NAC tablets daily at 200 mg per day for three months. The control group was the same patients before taking the medication.
Settings and conduct
This study was performed on 50 infertile patients with terato-asetenozospermia referred to Qom Fertility and Infertility Center for Treatment.
Participants/Inclusion and exclusion criteria
Entry criteria: normal anatomy of the genital area; infertility due to teratology - asthenospermia wHO2010 criteria
Intervention groups
Participant: Those who are invited to participate in the study are categorized in the treatment group after obtaining informed consent. The control group is the same patients before taking the medication.
Evaluation of the effects of N-Acetyl cysteine on sperm parameters, biochemical-hormonal factors,c hromatin integrity and NRF2 ,HSPA2genes expression in the terato-astenozoospermic men.
Public title
Evaluation of the effects of N-Acetyl cysteine on sperm parameters,chromatin and genes expression in the terato-astenozoospermic men.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Entry criteria: normal anatomy of the genital area; infertility due to teratology - asthenospermia wHO2010 criteria
Exclusion criteria:
Exclusion Criteria: Genital infection during the study; systemic medication for other infections; intake of dietary supplements 3 months before study; positive history of contact with chemical substances, solvents and inorganic substances; specimens from subjects with known etiology (varicocele, cryptorchidism, urinary tract infection, trauma, chemotherapy and etc.); individuals younger than 20 years or older than 40 years old; Individuals with varicocele; prostatitis; epidimitis; orchidism; mumps; testicular trauma; hyperthyroidism; hypothyroisdism; diabetes; thalassemia major; genetic disorders affecting infertility (Klinefelter , Noonan syndrome , microdeletion of chromosome Y, the mitochondrial DNA mutations); histotry of hernia surgery; vasectomy; consumption of antioxidant drugs
Age
From 25 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
50
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 Qom Azad University
Street address
NO.15,Khordad Ave.,Qom Aazd university
City
Qom
Province
Ghoum
Postal code
3719198195
Approval date
2018-01-22, 1396/11/02
Ethics committee reference number
IR.IAU.Qom.REC.1396.55
Health conditions studied
1
Description of health condition studied
Terato-Asethenozospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
sperm morphology
Timepoint
before and after taking drug
Method of measurement
Optical microscope, based WHO criteria (2010)
2
Description
Sperm motility
Timepoint
before and after taking drug
Method of measurement
Optical microscope, based WHO criteria (2010)
3
Description
Sperm concentration
Timepoint
before and after taking drug
Method of measurement
Optical microscope, based WHO criteria (2010)
4
Description
DNA fragmentation
Timepoint
before and after taking drug
Method of measurement
Fluorescent microscope
5
Description
Protamine deficiency
Timepoint
before and after taking drug
Method of measurement
Fluorescent microscope
6
Description
antioxidant enzymes
Timepoint
before and after taking drug
Method of measurement
spetophotometery
7
Description
gene expression
Timepoint
before and after taking drug
Method of measurement
RT- PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group or NAC group:received three tablets of NAC(200 mg daily) for three months.
Category
Treatment - Drugs
2
Description
Control group:before received three tablets of NAC(200 mg )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
infertility center of Qom
Full name of responsible person
Dr.rahil janatifar
Street address
Infertility Treatment Center, College of Jihad, Imam Khomeini Town, Islami Square, Shabnam Ave.
City
Qom
Province
Ghoum
Postal code
02532700154
Email
janatifar@acecr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Infertility Center of Qom
Full name of responsible person
Dr.Rahil Janatifar
Street address
Qom.Infertiliy Center of Qom
City
Qom
Province
Ghoum
Postal code
02532700154
Email
Rahiljanati2016@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Infertility Center of Qom
Proportion provided by this source
100
Public or private sector
Private
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
Infertility Center of Qom
Full name of responsible person
Dr.Rahil Janatifar
Position
PhD Student Research of Develoment Biology
Latest degree
Master
Other areas of specialty/work
Street address
Qom.Infertiliy Center of Qom
City
Qom
Province
Ghoum
Postal code
02532700154
Phone
+98 25 3270 0155
Fax
Email
janatifar@acecr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Rahil Janatifar
Position
PhD Student Research of Develoment Biology
Latest degree
Master
Other areas of specialty/work
Others
Street address
Infertility Treatment Center, College of Jihad, Imam Khomeini Town, Islami Square, Shabnam Ave.
City
Qom
Province
Ghoum
Postal code
3719198195
Phone
+98 25 3270 0155
Fax
+98 25 3270 0154
Email
janatifar@acecr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Rahil Janatifar
Position
PhD Student Research of Develoment Biology
Latest degree
Master
Other areas of specialty/work
Others
Street address
Infertility Treatment Center, College of Jihad, Imam Khomeini Town, Islami Square, Shabnam Ave.
City
Qom
Province
Ghoum
Postal code
3719198195
Phone
+98 25 3270 0155
Fax
+98 25 3270 0154
Email
janatifar@acecr.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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main consequences can be used
When the data will become available and for how long
The interval after the entry of the article and the results
To whom data/document is available
A portion of the data may be provided to the Urologist
Under which criteria data/document could be used
Check the effects of the drug
From where data/document is obtainable
Infertility Center, Qom University Jihad
What processes are involved for a request to access data/document
Data and documentation can be used after taking the drug and reviewing the results and registering the article