This triple-blind randomized controlled clinical trial aimed to compare the effect of ceratonia siliqua fruit oral capsule and vtamin E, on the semen parameters in infertile men.The target population of infertile men referring to infertility clinic of Al-Zahra hospital in Tabriz, which for at least one year of infertility is going on and no cause of male infertility has been established. Inclusion criteria: 20-45 years,abnormal spermogram, non-smoking and no addiction. Exclusion criteria: Being azospermc, anatomical abnormalities and infection of genital tract, taking any other chemical, or certain herbal infertility drugs and vitamin E.
From seventy of infertile men, 35 men will receive ceratonia siliqua capsules and 35 men will receive vitamin E capsules for three months.The primary outcome of the study was to determine the parameters of number, motility and morphology of sperm.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041027311N1
Registration date:2017-02-14, 1395/11/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-14, 1395/11/26
Registrant information
Name
Behnaz Sadeghzadeh Oskouei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 0364
Email address
sadeghzadehb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Ceratonia siliqua fruit oral capsule and vitamin E on semen parameters in idiopathic infertile men
Public title
Comparison of the effect of Ceratonia siliqua fruit oral capsule and vitamin E in male infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-45 years; married infertile man for at least one year with idiopathic abnormal spermogram about number; motility and morphology according to the World Health Organization (sperm count Less than 20 million per milliliter,type A mobility less than 25 percent and type B mobility less than 50% and normal morphology less than 30% ); non-smoking and non-alcoholism and drug users; desire to participate in the study; the ability to read and write
Exclusion criteria:
Being azospermic; infection and anatomical abnormalities of the genital tract such as duct blockage; to develop a varicocele ; surgery or need to do pelvic region surgery; diseases as cancer, liver and gallbladder, diabetes, thyroid, kidney failure, uncontrolled hypertension, cerebral hemorrhage, retinal hemorrhage, unilateral testicular atrophy; history of chemotherapy drugs, corticosteroids, anticoagulation, testosterone, antiandrogen; taking any other chemical, or certain herbal infertility drugs during the project and in the last quarter; recent consumption of vitamin E
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
118-51665
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.TBZMED.REC.1395.1130
Health conditions studied
1
Description of health condition studied
male infertility
ICD-10 code
N46
ICD-10 code description
male infertility
Primary outcomes
1
Description
sperm count
Timepoint
Before and three months after intervention
Method of measurement
Semen analysis
2
Description
sperm motility
Timepoint
Before and three months after intervention
Method of measurement
Semen analysis
3
Description
sperm morphology
Timepoint
Before and three months after intervention
Method of measurement
Semen analysis
Secondary outcomes
1
Description
sexual function
Timepoint
Before and three months after intervention
Method of measurement
Sexual Function Questionnaire
2
Description
Side events
Timepoint
three months after intervention
Method of measurement
check list complete
3
Description
Satisfaction with treatment received
Timepoint
three months after intervention
Method of measurement
check list complete
Intervention groups
1
Description
Intervention Group: 500 mg carob fruit Oral Capsules three times a day for 90 days
Category
Treatment - Drugs
2
Description
Control group: oral 500 mg vitamin E capsules containing 100 mg of vitamin E and 400 mg starch
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
Sima Sanagoo
Street address
Baghshmal Crossroads
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of 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
Sima Sanagoo
Position
Student of Master of Sciences in Midwifery
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty, South Shariati Street,Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 914 102 4284
Fax
Email
www.midwife.life20@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Behnaz Sadeghzadeh Oskuei
Position
PhD in Reproductive Biology
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty, South Shariati Street,Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 914 109 3771
Fax
Email
repbio.sbmu@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sima Sanagoo
Position
Student of Master of sciences in midwifery
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty, South Shariati Street,Tabriz, Iran
City
Tabriz
Postal code
Phone
00
Fax
Email
www.midwife.life20@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)