Evaluating the relative expression and effects of methyltransferase on global genomic methylation rate in sperms of Oligoasthenoteratozoospermia patients with protamine deficiency before and after of folic acid uptake
The goal is to evaluate semen parameters and sperm chromatin DNA methylation after taking folic in men with severe sperm abnormalities.
Among men referred to Yazd Research Institute for Infertility, 50 men who are seeking treatment for infertility, sperm analysis has fewer parameters according to Word health Organisation criteria and protamine deficiency (CMA3) test are selected and divided into two groups and after medication will be reviewed. The 30 men who have normal parameters and are normal CMA3 will be in a control group. In the intervention group after andrology assessments will be randomly divided into two groups of 25 patients, treated with vitamin E and selenium with or without folic acid for two months .
After washing the samples in different groups, the viability of sperm with eosin,cellular tests to evaluate sperm chromatin integrity will be done. These tests include aniline blue, toluidine blue.
To evaluate genetically, sperm samples will be prepared by with buffer and divided into two parts and stored frozen at -80 ° C. After preparation of the samples, RNA extraction protocol is performed. Then specimens are examined by PCR Real time. After two months, the patients will be genetically re-examination and then the results will be discussed between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507285261N2
Registration date:2016-03-27, 1395/01/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-27, 1395/01/08
Registrant information
Name
Tahereh Rahiminia
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4490 4272
Email address
t_rahiminia@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd ]nstitute of Reproductive Sciences
Expected recruitment start date
2015-08-22, 1394/05/31
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the relative expression and effects of methyltransferase on global genomic methylation rate in sperms of Oligoasthenoteratozoospermia patients with protamine deficiency before and after of folic acid uptake
Public title
ٍffects of the relative expression of genes of sperm DNA methyltransferase on global methylation in patients with severe sperm abnormalities before and after folic acid uptake
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria includes severe sperm parameters and protamine disrupted, age less than 40, avoiding the use of drugs or alcohol, and varicocele
Exclusion criteria: Unwillingness to continue during study,Diabetes,Blood Hypertension, obesity
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd Institute for Reproductive Sciences
Street address
Bu Ali ُSt, Safaieh
City
Yazd
Postal code
8916877391
Approval date
2014-05-13, 1393/02/23
Ethics committee reference number
IR.SSU.RSI.RES.1394.8
Health conditions studied
1
Description of health condition studied
Oligospermia
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Sperm parameters including count, motility, morphology
Timepoint
Two months after the intervention
Method of measurement
Microscopic examination of sperm
2
Description
Relative gene expression of methyltransferase
Timepoint
Two months after the intervention
Method of measurement
PCR Real time
3
Description
Phosphate group condensation
Timepoint
Two months after the intervention
Method of measurement
Toloidine Blue
4
Description
Protamin deficiency
Timepoint
Two months after the intervention
Method of measurement
CMA3
Secondary outcomes
1
Description
Flatulence, insomnia
Timepoint
Two month after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
folic acid tablet in intervention group
Category
Treatment - Drugs
2
Description
no intervention in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Infertility Center
Full name of responsible person
Tahereh Rahiminia
Street address
Yazd Infertility Center
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Khalili
Street address
Bu Ali, Safaieh
City
Yazd
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd research and clinical center for infertility
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
Yazd Infertility Center
Full name of responsible person
Tahereh Rahiminia
Position
PhD student
Other areas of specialty/work
Street address
Yazd Infertility Center, Bu-Ali, Safaieh
City
Yazd
Postal code
89195-999
Phone
+98 35 3824 8343
Fax
Email
tahereh.rahiminia@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Infertility Center
Full name of responsible person
Dr Ali Reza Talebi
Position
PhD
Other areas of specialty/work
Street address
Yazd Infertility Center, Bu-Ali, Safaieh
City
Yazd
Postal code
89195-999
Phone
+98 35 3824 8348
Fax
Email
prof_talebi@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Infertility Center
Full name of responsible person
Tahereh Rahiminia
Position
PhD student
Other areas of specialty/work
Street address
Bu-Ali, Safaieh
City
Yazd
Postal code
89185-999
Phone
+98 35 3824 8348
Fax
Email
tahereh.rahiminia@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)