Comparison and examination of sperm quality (sperm concentration, movement and morphology) of infertile men with and without the use of Blomax drug in Bandar Abbas city
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 100 patients. Rand function and Excel software will be used for randomization.
Settings and conduct
This study will be an interventional, randomized, parallel, double-blind clinical trial (patient and evaluator researcher) on infertile men aged 18 to 45 referring to Bandar Abbas fertility clinics. All men receive standard treatment. Then, by stratified randomization, they will be placed in one of the two study groups (blomax recipients and placebo).
Participants/Inclusion and exclusion criteria
Infertile men aged 18 to 45 living in Bandar Abbas with enough sleep at night (6 hours) will be included in the study. Men with a history of heart disease, uncontrolled chronic diseases (diabetes, hypertension, kidney failure, autoimmunity, malignancy) and patients with poor drug compliance will be excluded from the study.
Intervention groups
All infertile men will receive standard treatment. One group will receive the main treatment and Blomax medicine and the second group will receive the main treatment and placebo (in capsule form).
Main outcome variables
Sperm quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241031063553N1
Registration date:2024-11-16, 1403/08/26
Registration timing:prospective
Last update:2024-11-16, 1403/08/26
Update count:0
Registration date
2024-11-16, 1403/08/26
Registrant information
Name
Fateme Zahra Ahaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3528 7001
Email address
fazaahaz98@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-06-10, 1404/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Blomax drug on the sperm quality of infertile men
Public title
The effect of Blomax drug on the sperm quality of infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to enter the study
The patient is a resident of Bandar Abbas
Regular sleep at night (at least 6 hours of sleep at night)
Exclusion criteria:
Lack of consent to enter the study
The patient is a traveler or not a resident of Bandar Abbas
Have a history of recent surgery and history of angiography
Lack of control of diabetes and blood pressure diseases
Not having autoimmune diseases
Absence of any type of malignancy
Lack of regular use of heart medications (if the case is known for ischemic heart diseases)
Congenital heart diseases
Renal failure
Consumption of alcohol and other drugs (except cigarettes)
Age
From 18 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to experimental and control groups using the random block method. To perform randomization using quadruple blocks, first by throwing 16 regular hexagons 16 times, a random sequence of 16 quadruple blocks will be generated from the following blocks: AABB-ABAB-ABBA-BAAB-BABA-BBAA In the sequence, there will be 50 of each letter A and B. According to the above block, 50envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 100. The person delivering the envelopes to the patients does not know the letters inside. Randomization is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each envelope. Patients who received the letter A will be in the Blomax drug recipients group and patients who received the letter B will be in the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
After assigning the patients randomly, two groups of patients will use the same medicine with the same packaging and they will not know the type of treatment received.The researcher who evaluates the symptoms and recovery of the patients also does not know the type of treatment received by the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Qeshm International Branch
Street address
Faculty of Medicine, International campus building, Qeshm Islamic Azad University, Qeshm Island
City
Qeshm
Province
Hormozgan
Postal code
795151393
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.IAU.BA.REC.1403.001
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Improving sperm quality (morphology, movement and concentration)
Timepoint
At the beginning of the study and three months after the start of treatment
Method of measurement
The rate of improvement in spermography (volume/number/movement/shape/turbidity/ph)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recipients of the main treatment and Blomax capsules (supplement)
Category
Treatment - Drugs
2
Description
Control group: recipient of original treatment and placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
azmayeshgah bimarestan emam reza bandrabbas 37 / 5,000 Laboratory of Imam Reza Bandar Abbas Hospital
Full name of responsible person
Dr. Mohammad Reza Zeyghami
Street address
Laboratory of Imam Reza Hospital,Nayband e Shomali, Imam Khomeini Blvd, Bandar Abbas, Hormozgan Province
City
Bandar abbas
Province
Hormozgan
Postal code
۷۹۱۵۷۵۳۳۷۵
Phone
+98 76 3333 3338
Email
zeighamireza@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Behnaz Khamsan
Street address
Faculty of Medicine, Islamic Azad University Qeshm Branch International Campus Building, Dargahan Blvd, Qeshm Island, Hormozgan Province
City
Bandar Abbas
Province
Hormozgan
Postal code
795151393
Phone
+98 76 3528 7001
Email
qeshm@cms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Zeighami
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 3, 3rd Floor, Sharif Doctors Building, Alley behind Amirizad Pharmacy, Seyed Jamaluddin Asadabadi St, Bandar Abbas, Hormozgan Province
City
Bandar abbas
Province
Hormozgan
Postal code
4917765594
Phone
+98 76 3221 1120
Email
Zeighamireza@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Zeighami
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 3, 3rd Floor, Sharif Doctors Building, Alley behind Amirizad Pharmacy, Seyed Jamaluddin Asadabadi St, Bandar Abbas, Hormozgan Province
City
Bandar abbas
Province
Hormozgan
Postal code
4917765594
Phone
+98 76 3221 1120
Email
Zeighamireza@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Zahra Ahaz
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Farmandari Ave, Azadegan Blvd, Qeshm Town
City
Qeshm
Province
Hormozgan
Postal code
4917765594
Phone
+98 76 3528 7001
Fax
Email
fazaahaz98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The entire data file is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Dr. Fatemeh Zahra Ahaz/ general practitioner/ project manager/ contact number: 09108908619/ email: fazaahaz98@gmail.com
What processes are involved for a request to access data/document
The applicant should provide a description of his study and the purpose of receiving the data in an e-mail format along with his follow-up file (research Proposal). Then, after 3 months, the file will be provided to the person.