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Protocol summary
Primary outcome is changes in sperm parameters after treatment
Secondary outcomes are changes in serum levels of reproductive hormones; Malondialdehyde (MDH) andTotal antioxidant capacity (TAC).
Primary outcome is changes in sperm parameters after treatment
Secondary outcomes are changes in serum levels of reproductive hormones; Malondialdehyde (MDH) andTotal antioxidant capacity (TAC), superoxide dismutase enzyme, the levels of Zinc and Selenium.
Primary outcome is changes in sperm parameters after treatment Secondary outcomes are changes in serum levels of reproductive hormones; Malondialdehyde (MDH) andTotal antioxidant capacity (TAC), superoxide dismutase enzyme, the levels of Zinc and Selenium.
پیامد اولیه تغییر در پارامترهای اسپرموگرام پس از درمان است.
پیامدهای ثانویه شامل تغییرات در سطح سرمی هورمون هایتولید مثل، مالون دی آلدئید (MDH) و ظرفیت آنتی اکسیدانی کل (TAC) میباشد.
پیامد اولیه تغییر در پارامترهای اسپرموگرام پس از درمان است.
پیامدهای ثانویه شامل تغییرات در سطح سرمی هورمون هایتولید مثل، مالون دی آلدئید (MDH) ،ظرفیت آنتی اکسیدانی کل (TAC)، آنزیم سوپر اکسید دیسموتاز و سطوح زینک و سلنیوم میباشد.
پیامد اولیه تغییر در پارامترهای اسپرموگرام پس از درمان است. پیامدهای ثانویه شامل تغییرات در سطح سرمی هورمون هایتولید مثل، مالون دی آلدئید (MDH) و ،ظرفیت آنتی اکسیدانی کل (TAC)، آنزیم سوپر اکسید دیسموتاز و سطوح زینک و سلنیوم میباشد.
General information
1
1
2-3
3
2-3
2018-02-20, 1396/12/01
2018-04-21, 1397/02/01
2018-0204-2021 00:00:00
2018-09-21, 1397/06/30
2019-03-11, 1397/12/20
20182019-0903-2111 00:00:00
empty
Secondary analysis of data
Secondary analysis of data
empty
آنالیز ثانویه
آنالیز ثانویه
Comparison the effect of Ceratonia siliqua fruit extract and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men.
Comparison the effect of Ceratonia siliqua fruit syrup and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men.
Comparison the effect of Ceratonia siliqua fruit extractsyrup and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men.
مقایسه تاثیر عصاره میوه خرنوب و ویتامین E بر فاکتورهای اسپرموگرام، شاخصهای استرس اکسیداتیو و میزان هورمونهای جنسی در مردان نابارور
مقایسه تاثیر شربت میوه خرنوب و ویتامین E بر فاکتورهای اسپرموگرام، شاخصهای استرس اکسیداتیو و میزان هورمونهای جنسی در مردان نابارور
مقایسه تاثیر عصارهشربت میوه خرنوب و ویتامین E بر فاکتورهای اسپرموگرام، شاخصهای استرس اکسیداتیو و میزان هورمونهای جنسی در مردان نابارور
Secondary outcomes
#1
empty
superoxide dismutase enzyme
superoxide dismutase enzyme
empty
آنزیم سوپر اکسید دیسموتاز
آنزیم سوپر اکسید دیسموتاز
empty
Before and three months after intervention
Before and three months after intervention
empty
قبل و سه ماه پس از مداخله
قبل و سه ماه پس از مداخله
empty
Calorimetric
Calorimetric
empty
کالریمتریک
کالریمتریک
#2
empty
Zinc
Zinc
empty
زینک
زینک
empty
Before and three months after intervention
Before and three months after intervention
empty
قبل و سه ماه پس از مداخله
قبل و سه ماه پس از مداخله
empty
Atomic Absorption Spectrophotometry
Atomic Absorption Spectrophotometry
empty
اسپکتروفوتومتری جذب اتمی
اسپکتروفوتومتری جذب اتمی
#3
empty
Selenium
Selenium
empty
سلنیوم
سلنیوم
empty
Before and three months after intervention
Before and three months after intervention
empty
قبل و سه ماه پس از مداخله
قبل و سه ماه پس از مداخله
empty
Atomic Absorption Spectrophotometry
Atomic Absorption Spectrophotometry
empty
اسپکتروفوتومتری جذب اتمی
اسپکتروفوتومتری جذب اتمی
Recruitment centers
#1
Name of recruitment center - English: Fatemezahra infertility center
Name of recruitment center - Persian: مرکز ناباروری فاطمه زهرا
Full name of responsible person - English: Parvaneh Mirabi
Full name of responsible person - Persian: پروانه میرابی
Street address - English: Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences
Street address - Persian: بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: ۴۷۱۷۶-۴۷۷۴۵
Phone: +98 11 3227 8510
Fax:
Email: parvaneh.mirabi@gmail.com
Web page address:
Name of recruitment center - English: Fatemezahra infertility center
Name of recruitment center - Persian: مرکز ناباروری فاطمه زهرا
Full name of responsible person - English: Dr Parvaneh Mirabi
Full name of responsible person - Persian: دکتر پروانه میرابی
Street address - English: Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences
Street address - Persian: بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: ۴۷۱۷۶-۴۷۷۴۵
Phone: +98 11 3227 8510
Fax:
Email: parvaneh.mirabi@gmail.com
Web page address:
Name of recruitment center - English: Fatemezahra infertility center Name of recruitment center - Persian: مرکز ناباروری فاطمه زهرا Full name of responsible person - English: Dr Parvaneh Mirabi Full name of responsible person - Persian: دکتر پروانه میرابی Street address - English: Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences Street address - Persian: بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل City - English: Babol City - Persian: بابل Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: ۴۷۱۷۶-۴۷۷۴۵ Phone: +98 11 3227 8510 Fax: Email: parvaneh.mirabi@gmail.com Web page address:
Sharing plan
undecided
no
undecidedno
Protocol summary
Study aim
Comparison the effect of Ceratonia siliqua fruit extract and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men
Design
This is a parallel, singl blind, randomized controlled trial and no stratification will be used.
Settings and conduct
This study will be conducted at Fateme zahra infertility and reproductive health Center affiliated to Babol university of medical sciences and take place at urology clinic. This center is one of the best-equipped diagnostic and therapeutic infertility centers and is a referral center for infertility problems in north of Iran.
Participants/Inclusion and exclusion criteria
The marital males with infertility complaints were admitted to the Urology Clinic of Fatemeh Zahra Infertility Center who have disorder in sperm concentration, motility or morphology in their spermatogenesis tests after confirmation of urologist and by having inclusion criteria and Satisfaction is entered into the study
Intervention groups
Patients will be assigned to receive carob extract twice a day or vitamin E (comparison group) 100 mg once a day for 3 months.
Main outcome variables
Primary outcome is changes in sperm parameters after treatment
Secondary outcomes are changes in serum levels of reproductive hormones; Malondialdehyde (MDH) andTotal antioxidant capacity (TAC), superoxide dismutase enzyme, the levels of Zinc and Selenium.
General information
Reason for update
Secondary analysis of data
Acronym
IRCT registration information
IRCT registration number:IRCT20171209037794N1
Registration date:2018-02-10, 1396/11/21
Registration timing:prospective
Last update:2020-09-12, 1399/06/22
Update count:1
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Parvaneh Mirabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 7958
Email address
parvaneh_mirabi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Ceratonia siliqua fruit syrup and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men.
Public title
Effect of Ceratonia siliqua on male infertility.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 - 45 years of age, who had complained of infertility for at least 12 months, and had no history of surgical or medical treatments for infertility
Unspecified oligospermia based on WHO criteria (sperm count less than 20 million per ml, type A motility less than 25%, and type B motility less than 50%; normal morphology less than 15%);
Having a BMI less than 30
Not smoking, drinking alcohol, and addiction to substance
Normal level of gonadotropins, testosterone and Prolactin
Lack of systemic diseases, such as diabetes and thyroid, cerebrovascular disease and had no history of chemotherapy
Exclusion criteria:
A history of vasectomy or obstructive azoospermia
Azospermia and chromosomal abnormalities such as kleinfelter's Syndrome
Hypogonadism or pituitary abnormalities
The use of antioxidant supplements in the last three months
Taking medications that stimulate the sexual system or disrupt the sex hormones
Having severe physical activity
Genital tract infection, recurrent or residual varicocoele and history of cryptorchidism
Infectious diseases characterized by fever and leukocytosis.
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization will be used to achieve balance in the allocation of participants to intervention arms. Before initiation of the run- in phase of the study, two 40- sets of random numbers will be created by a member of the research team not involved in recruitment. 15 blocks with size of 4 and combination of A for the carob and B for vitamin E group will be prepared. Allocation sequence will be password-protected and only accessible to the reproductive health researcher. She folds the paper containing 4-size blocks, put them in the standard thick envelopes and write the serial numbers on them. All of the envelope will be kept at the recruitment center. Thus, for every eligible patient, the researcher randomly selects one of the envelopes after assign subjects into intervention and comparison group.
Blinding (investigator's opinion)
Single blinded
Blinding description
outcome assessor and data analyser will be blinded to group assignment for the exploratory outcomes of treatment, treatment completion and treatment response which will be assessed by medical staff not otherwise involved in the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Mazandaran, Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2018-01-24, 1396/11/04
Ethics committee reference number
MUBABOL.HRI.REC.1396.179
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46.1
ICD-10 code description
Oligospermia
Primary outcomes
1
Description
Sperm count
Timepoint
Before and three months after intervention
Method of measurement
Semen analysis
2
Description
Sperm morphology
Timepoint
Before intervention and three months after intervention
Method of measurement
Semen analysis
3
Description
Sperm motility
Timepoint
Before and three months after intervention
Method of measurement
Semen analysis
Secondary outcomes
1
Description
Serum concentrations of Malondialdehyde
Timepoint
Before and three months after intervention
Method of measurement
TBARS method using Spectrophotometer
2
Description
Sex hormones
Timepoint
Before and three months after intervention
Method of measurement
Eliza
3
Description
superoxide dismutase enzyme
Timepoint
Before and three months after intervention
Method of measurement
Calorimetric
4
Description
Zinc
Timepoint
Before and three months after intervention
Method of measurement
Atomic Absorption Spectrophotometry
5
Description
Selenium
Timepoint
Before and three months after intervention
Method of measurement
Atomic Absorption Spectrophotometry
Intervention groups
1
Description
Intervention group: Ceratonia siliqua syrup twice a day for three months
Category
Treatment - Drugs
2
Description
Control group: 100 mg capsule of vitamin E once a day for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemezahra infertility center
Full name of responsible person
Dr Parvaneh Mirabi
Street address
Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3227 8510
Email
parvaneh.mirabi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0557
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Parvaneh Mirabi
Street address
Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 0558
Email
parvaneh.mirabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
3
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 0557
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Babol University of Medical Sciences
Full name of responsible person
Dr Parvaneh Mirabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 0558
Email
parvaneh.mirabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Parvaneh Mirabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 0557
Email
parvaneh.mirabi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Parvaneh Mirabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 0558
Email
parvaneh.mirabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD