Protocol summary

Study aim
Investigating the effect of supplements on sperm parameters (motility, number, density, vitality, morphology and chromatin) in infertile male before and after treatment
Design
A clinical trial with a group of patients receiving herbal supplements before and after for 90 days, with only groups, not blind, randomized, phase 2 on 50 patients.
Settings and conduct
Infertile male refer to Yazd Research Institute of Reproductive Sciences, with a mean age of 28.5 years (range 20–45 years) presenting with male factor infertility (primary or secondary) for at least 1 year. All patients give informed consent and are free to withdraw from the trial at any point. They are questioned about medical and surgical history and about alimentary diet. Patients are given an oral daily ( 2 capsules, twice daily) for 3 months. we do a semen analysis before treatment and another semen analysis at the end of 90 days of treatment.
Participants/Inclusion and exclusion criteria
oligoasthenoteratospermia men with no history of smoking, alcohol and addiction, no history of systemic disease such as diabetes and thyroid disease, cerebrovascular disease and no history of chemotherapy and genital tract infection, taking antioxidant supplements in the last three months and during the study, taking chemical drugs during the study
Intervention groups
Patient group including infertile oligoasthenoteratospermia men
Main outcome variables
Improving sperm parameters, improving male infertility, losing body weight

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221120056545N1
Registration date: 2023-01-11, 1401/10/21
Registration timing: prospective

Last update: 2023-01-11, 1401/10/21
Update count: 0
Registration date
2023-01-11, 1401/10/21
Registrant information
Name
mahdie Hemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3730 4850
Email address
m.hemati1420@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of multiple oral supplements on sperm parameters in men with reproductive disorders compared with control
Public title
supplement in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile men who do not have children after one year of intercourse.
Exclusion criteria:
Age
From 20 years old to 45 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethics Committee of Yazd Reproductive Sciences Institute
Street address
BouAli Ave, Safaeie, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2022-09-04, 1401/06/13
Ethics committee reference number
IR.SSU.RSI.REC.1401.012

Health conditions studied

1

Description of health condition studied
Infertile male
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sperm parameters
Timepoint
Measurement of sperm parameters before and after 90 days of taking supplement
Method of measurement
Measurement of sperm parameters with microscope and kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Infertile male who take the supplement (two pills in the morning and at night for 90 days).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Dr Mahdie Hemati, Mr Majid Naghib zade, Dr Alimohammad Abdoli
Street address
Bou Ali Ave., Safaeie., Yazd Town
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7087
Email
m.hemati1420@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd Reproductive Sciences Institute
Full name of responsible person
Vice President of Research and Technology
Street address
Yazd Reproductive Sciences Institute, Bu Ali St, Safaiyeh
City
yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
m.hemati1420@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Reproductive Sciences Institute
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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Abdoli, Dr. Mahdie Hemati, Mr. Majid Naghibzadeh
Position
Doctor, researcher, researcher
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Yazd Reproductive Sciences Institute, Bu Ali St, Safaiyeh
City
yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
m.hemati1420@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Reproductive Sciences Institute
Full name of responsible person
Dr. Ali Mohammad Abdoli, Dr. Mahdie Hemati, Mr. Majid Naghibzadeh
Position
Doctor, researcher, researcher
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Yazd Reproductive Sciences Institute, Bu Ali St, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
m.hemati1420@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahdie Hemati
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Yazd Reproductive Sciences Institute, Bu Ali St, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
m.hemati1420@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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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