We conducted this study to determine the effects of saffron(Crocus savitus)on the results of semen analysis (semen volume,count,motility and morphology)after varicocelectomy,probable side effects of saffron and assessment of NNT(Number To Treat)and CI (Confidence Interval)of 95% in the use of saffron.Based on previous studies, in this double blind clinical trial 60 nonsmoker 20 to 35 year old men without any systemic or urogenital disease(and history of childhood disease),or the use of approved drugs or illegal ones such as opiums,stimulants,hallocinogens and inhalants, or the history of testis trauma, that may affect the spermatogenesis and men without the history of prior varicocelectomy,atrophic testis or FSH above the normal range will get selected and others will exclude. This study was approved by the ethics committee of Tabriz University of medical sciences. Men after complete interview and urological examinations and analysis of semen parameters will be operated and then will be administered 60mg saffron or placebo in similar capsules for 6 months. Saffron capsules will administer 3 times a week during the study course to 30 patients and placebo capsules like saffron capsules will administer to other 30 patients. Every disease, drug use or testicular trauma that may affect spermatogenesis or patient request results in exclusion of men during the study course. Semen analysis will again carry out and will compare with initial semen parameters in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403174181N8
Registration date:2014-04-10, 1393/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-10, 1393/01/21
Registrant information
Name
Yadollah Ahmadi AsrBadr
Name of organization / entity
Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1924
Email address
ahmadiy@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research,Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Saffron on semen analysis in infertile men after varicocelectomy
Public title
The Effect of Saffron on semen analysis in infertile men after varicocelectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Married men infertile with varicocele; Patients between 20 to 35 years; Non-smokers; Patients who are willing to participate in th study;
Exclusion criteria: Smoking;Marijuana Patients consumer, Cocain, Alcohol and other, Patients with acute infections; Patients who have previously undergone surgery; Patients with unilateral testicular atrophy were; Patients with Azoospermia
Age
From 20 years old to 35 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
vice chancellor of research, Tabriz University of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
5138665793
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
5/4/10354
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Effect of saffron on improvement of at least one of the parameters, morphology or motility of sperm
Timepoint
End of the treatment period of 6 months
Method of measurement
Experiment
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Placebo capsules contain a number, every other day, for six months
Category
Placebo
2
Description
Intervention group: daily 60-milligram capsules of saffron provided Bhamen approved by the Ministry of Health of Iran and Iran's national standard, every other day for six months a number
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra , Sina, Emam Reza, Hospital
Full name of responsible person
Dr.Yadollah Ahmadi AsrBadr
Street address
Alzahra Hospital, bagh-shomal; Artesh Street South;Azadi Avenue, Sina Hospital,University Avenue, Golgasht Street,Emam Reza, Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor of research, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Golgasht Street; Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor of research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Yadollah Ahmadi AsrBadr
Position
Urology Physician, Associate
Other areas of specialty/work
Street address
Golgasht Street; Tabriz University of Medical Sciences