Protocol summary
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Study aim
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Comparison the effect of Ceratonia siliqua fruit extract and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men
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Design
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This is a parallel, singl blind, randomized controlled trial and no stratification will be used.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Patients will be assigned to receive carob extract twice a day or vitamin E (comparison group) 100 mg once a day for 3 months.
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Main outcome variables
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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
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Reason for update
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Secondary analysis of data
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Acronym
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IRCT registration information
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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
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Registration date
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2018-02-10, 1396/11/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-21, 1397/02/01
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Expected recruitment end date
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2019-03-11, 1397/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison the effect of Ceratonia siliqua fruit syrup and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men.
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Public title
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Effect of Ceratonia siliqua on male infertility.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old to 45 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-24, 1396/11/04
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Ethics committee reference number
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MUBABOL.HRI.REC.1396.179
Health conditions studied
1
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Description of health condition studied
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Male infertility
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ICD-10 code
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N46.1
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ICD-10 code description
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Oligospermia
Primary outcomes
1
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Description
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Sperm count
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Timepoint
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Before and three months after intervention
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Method of measurement
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Semen analysis
2
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Description
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Sperm morphology
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Timepoint
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Before intervention and three months after intervention
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Method of measurement
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Semen analysis
3
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Description
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Sperm motility
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Timepoint
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Before and three months after intervention
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Method of measurement
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Semen analysis
Secondary outcomes
1
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Description
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Serum concentrations of Malondialdehyde
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Timepoint
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Before and three months after intervention
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Method of measurement
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TBARS method using Spectrophotometer
2
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Description
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Sex hormones
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Timepoint
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Before and three months after intervention
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Method of measurement
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Eliza
3
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Description
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superoxide dismutase enzyme
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Timepoint
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Before and three months after intervention
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Method of measurement
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Calorimetric
4
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Description
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Zinc
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Timepoint
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Before and three months after intervention
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Method of measurement
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Atomic Absorption Spectrophotometry
5
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Description
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Selenium
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Timepoint
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Before and three months after intervention
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Method of measurement
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Atomic Absorption Spectrophotometry
Intervention groups
1
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Description
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Intervention group: Ceratonia siliqua syrup twice a day for three months
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Category
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Treatment - Drugs
2
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Description
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Control group: 100 mg capsule of vitamin E once a day for three months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
3
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable