A comparative study of probiotic and antioxidant use on the improvement of semen parameters in men with primary idiopathic infertility: a randomized clinical trial
Determining the use of probiotics and antioxidants on improving semen parameters in men with primary idiopathic infertility
Design
This study is a randomized, three-blind, phase 3 clinical trial performed on 102 patients. Patients are randomly divided into 3 groups of 34 by random allocation software and one group is taking probiotic and one group is taking anti oxidant and the other group is taking a placebo.
Settings and conduct
This study is performed in Yazd Infertility Center and Isfahan Urology Clinic. Patients with primary idiopathic infertility are divided into three groups: a probiotic group, an antioxidant group, and a placebo group. Sperm samples are taken for analysis before the study and 3 months after the study. This study is three-way blind and the patient, caregiver and analyzer do not know the study group.
Participants/Inclusion and exclusion criteria
The condition for admission is men with primary idiopathic infertility, and the conditions for not entering and leaving the study are:
1- Pyospermia
2- History of testicular surgery
3. History of chemotherapy or radiotherapy
4. Smoking
5 - History and current use of drugs affecting spermatogenesis such as tamoxifen, hcg, cytotoxic drugs such as immunosuppressants, anticonvulsants, androgens
6. History of sexually transmitted diseases
7- Epididymarkit
8- Testicular trauma
9-Prostatitis
10- Reluctance to participate in the study
11- Chromosomal abnormalities
12- Pregnancy event during the study
13- History of testicular torsion
Intervention groups
In this study, a probiotic group, an antioxidant group, and a placebo group were given.
A comparative study of probiotic and antioxidant use on the improvement of semen parameters in men with primary idiopathic infertility: a randomized clinical trial
Public title
The effect of probiotic and antioxidant use on the semen parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men with primary idiopathic infertility
Age 18 to 45 years
Exclusion criteria:
Pyospermia
History of testicular surgery
History of chemotherapy or radiotherapy
smoking
History and current use of drugs that affect spermatogenesis such as tamoxifen, hcg, cytotoxic drugs such as immunosuppressants, anticonvulsants, androgens
History of sexually transmitted diseases
Epididymitis and orchitis
Testicular trauma
Prostatitis
Reluctance to participate in the study
Chromosomal abnormalities
Pregnancy event during the study
History of testicular torsion
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly assigned to 3 control and intervention groups (probiotics, antioxidants, and placebo) by random allocation software in individual units. Block randomization will be used with a block size of 6. Sealed envelopes containing a number attributed to each intervention group will be used. The patient and the practitioner are blinded to the intervention received.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a triple blind study in which the participants and the clinical caregiver and the analyzer are blind and patient group are selected by random allocation software.
Randomly assigned to the case or control group (probiotics, antioxidants, and placebo). Then, if he is in any group, he will receive a drug that is appropriate for the group, and all three drugs are similar in shape. But patients and caregivers do not know which medication or placebo they received, and outcome assessors do not know the participants and record their findings based on patient numbers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-09-04, 1400/06/13
Ethics committee reference number
IR.MUI.MED.REC.1400.443
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
seminal fluid volume
Timepoint
before intervention and 3 months after intervention
Method of measurement
semen analysis
2
Description
sperm count
Timepoint
before intervention and 3 months after intervention
Method of measurement
semen analysis
3
Description
sperm concentration
Timepoint
before intervention and 3 months after intervention
Method of measurement
semen analysis
4
Description
sperm motility
Timepoint
before intervention and 3 months after intervention
Method of measurement
semen analysis
5
Description
sperm morphology
Timepoint
before intervention and 3 months after intervention
Method of measurement
semen analysis
6
Description
DNA Fragmentation Index
Timepoint
before intervention and 3 months after intervention
Method of measurement
semen analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In this group, patients receive one Familact capsule containing 500 mg of synbiotics made by Zist takhmir Pharmaceutical Company for 3 months
Category
Treatment - Drugs
2
Description
Intervention group: In this group, they receive one sperigen capsule containing antioxidants made by Hayat Daru Iran Company daily for 3 months.
Category
Treatment - Drugs
3
Description
Control group: In this group, patients receive one capsule daily similar to the intervention group without effective substance for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Center
Full name of responsible person
Amirhosein Rahavian
Street address
Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7087
Email
amirrahavian@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Farshad Gholiour
Street address
Ostandari St
City
Isfahan
Province
Isfehan
Postal code
8134659691
Phone
+98 31 3222 2127
Email
gholipour@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
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
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
Assistant professor of Urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168814193
Phone
+98 31 3669 7898
Email
farshad.gholipoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
gholipour@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
gholipour@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available