The overall objective of the project to determine the health effects of mixtures of several plant on changes antioxidants in semen in men with oligospermia.This study is interventional.The samples number is 40 that herbal mixture with the shape of 700mg capsules produces and administrate it to the patients.
Semen samples after a minimum of 2 and a maximum of 7 days to refrain from sexual contact in sterile plastic containers for liquid semen collection and analysis will be done in terms of antioxidants semen.
The 700mg capsules dispose to the patients one-time daily.this 700mg capsules include equally proportio n of Onions, ginger, basil, cinnamon, orange peel, yellow and red watermelon seed and carrot seed . Once the patients in the first day and the second time after 6 months of drug will gate sample. Semen samples after a minimum of 2 and a maximum of 7 days of abstinence from sexual contact is collected in sterile plastic containers And kits for measuring vitamin E Semen with method of (HPLC) High-performance liquid chromatography will be done. Other specific kits for measuring serum antioxidants measured by radio immunoassay political will.
Inclusion criteria included patients with oligospermia without specific drugs using within the last six months without varicocele and without a history of systemic disease during the last six months and If there is a varicocele or systemic disease during the last six months or a particular drug within the last six months are excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012512146N3
Registration date:2014-07-24, 1393/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-24, 1393/05/02
Registrant information
Name
Laaya Farzadi
Name of organization / entity
Woman's Reproductive Health Research Center of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
farzadl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-19, 1391/10/30
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study mixed herbal drug administration on semen antioxidants and testestrone level in male infertility; oligospermia
Public title
Effect of herbal drugs on the semen antioxidants
Purpose
Treatment
Inclusion/Exclusion criteria
Men with oligospermia enter the study if they sign informed consent and if they use some other drugs or if they have another diseases such az varicocele that effect on sperm analysis, they exclude from the study.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golbad street
City
Tabriz
Postal code
Approval date
2014-06-26, 1393/04/05
Ethics committee reference number
9351
Health conditions studied
1
Description of health condition studied
oligospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Semen antioxidants level
Timepoint
Before the study and 6 months after study
Method of measurement
HPLC
2
Description
serum testestrone level
Timepoint
Before the study and 6 months after study
Method of measurement
ng/dl
Secondary outcomes
1
Description
Sperm count
Timepoint
Before the study and 6 months after study
Method of measurement
Semen analysis
Intervention groups
1
Description
The samples number is 40 that herbal mixture with the shape of 700mg capsules produces and administrate it to the patients.
Semen samples after a minimum of 2 and a maximum of 7 days to refrain from sexual contact in sterile plastic containers for liquid semen collection and analysis will be done in terms of antioxidants semen.
The 700mg capsules dispose to the patients one-time daily.this 700mg capsules include equally proportio n of Onions, ginger, basil, cinnamon, orange peel, yellow and red watermelon seed and carrot seed . Once the patients in the first day and the second time after 6 months of drug will gate sample. Semen samples after a minimum of 2 and a maximum of 7 days of abstinence from sexual contact is collected in sterile plastic containers And kits for measuring vitamin E Semen with method of (HPLC) High-performance liquid chromatography will be done. Other specific kits for measuring serum antioxidants measured by radio immunoassay political will.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility ward- Alzahra education and treatment center