Protocol summary
-
Study aim
-
This study aims to assess the effect of probiotic administration on male subjects with idiopathic infertility. We intend to evaluate the effect of supplementation with FamiLact probiotic compound on our participants regarding the level of DNA damage and protamine deficiency, as well as regular sperm parameters.
-
Design
-
A triple blinded, placebo-controlled clinical trial, randomized applying permuted blocks
-
Settings and conduct
-
60 patients recruited in Imam Reza Hospital will randomly be divided into two equal placebo- and probiotic receivers groups. Applying a triple blinding strategy, the patients, care providers, researchers, and the data analyzer will be masked. Patients in the treatment and placebo groups receive 500 mg of probiotic and identical placebo for 80 days respectively. In addition to regular semen parameters, level of DNA damage and protamine deficiency in sperm will be evaluated prior to intervention and after termination of the course of supplementation.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Men with idiopathic male infertility
Exclusion criteria: cryptorchidism, varicocele, chromosome abnormalities, leukocytospermia, epididymo-orchitis, genito-urinary traumas, prostatitis, testicular torsion, history of inguinal/genital surgery, history of hormone therapy, endocrinopathies, history or present use of cytotoxic/immunosuppressant/anticonvulsant/androgen drugs, recent sexually transmitted infection.
-
Intervention groups
-
Drug group: receiving of 500 mg of FamiLact containing probiotic bacterial strains and 10⁹ CFU of Fructooligosaccharides on a daily basis (1 capsule/day).
Control group: receiving 1 capsule of identical placebo per day.
-
Main outcome variables
-
Routine sperm parameters; sperm DNA damage; sperm protamine deficiency
General information
-
Reason for update
-
Due to termination of the trial.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20190824044599N1
Registration date:
2019-10-27, 1398/08/05
Registration timing:
prospective
Last update:
2021-02-27, 1399/12/09
Update count:
1
-
Registration date
-
2019-10-27, 1398/08/05
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-11-22, 1398/09/01
-
Expected recruitment end date
-
2019-12-21, 1398/09/30
-
Actual recruitment start date
-
2019-11-22, 1398/09/01
-
Actual recruitment end date
-
2020-05-02, 1399/02/13
-
Trial completion date
-
2020-05-02, 1399/02/13
-
Scientific title
-
Assessing the effect of probiotic administration on sperm DNA fragmentation, sperm parameters and seminal oxidative stress in men diagnosed with idiopathic infertility
-
Public title
-
Effect of probiotic administration on male infertility
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Infertile men with abnormal sperm analysis due to unknown underlying cause
Exclusion criteria:
Cryptorchidism
Varicocele
Chromosome abnormalities
Leukocytospermia
Epididymo-orchitis
History of trauma to genitourinary system
Prostatitis
History of testicular torsion
Previous inguinal surgeries
History of Hormonetherapy
History of endocrinopathies
History of medication with cytotoxic drugs, immunosuppressants, androgens, and anticonvulsants
Recent sexually transmitted infection
-
Age
-
From 18 years old
-
Gender
-
Male
-
Phase
-
2-3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Data analyser
-
Sample size
-
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
Participants must provide us with two semen samples: before and 80 days after receiving the intervention.
Actual sample size reached:
56
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
We will recruit permutation block randomization method. Regarding our sample size, 9 blocks containing 8 units (individuals) will be applied. Random sequence will be built on all the possible permutations. Due to our triple blinded design, no allocation concealment will be used.
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
Drug and placebo packings are identical and given to the participants according to randomization sequence. In the present study, health caregivers, researcher(s) in charge of data collection and manuscript drafting, as well as statistical analysis will be blinded.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-07-30, 1398/05/08
-
Ethics committee reference number
-
IR.AJAUMS.REC.1398.051
Health conditions studied
1
-
Description of health condition studied
-
Idiopathic male infertility
-
ICD-10 code
-
N46.9
-
ICD-10 code description
-
Male infertility, unspecified
Primary outcomes
1
-
Description
-
sperm concentration
-
Timepoint
-
Evaluating sperm concentration before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis
2
-
Description
-
Semen volume
-
Timepoint
-
Evaluating semen volume before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis
3
-
Description
-
Percentage of abnormal sperm morphology
-
Timepoint
-
Evaluating the percentage of abnormal sperm morphology before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis
4
-
Description
-
Percentage of sperm motility
-
Timepoint
-
Evaluating the percentage of motile sperm before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis
5
-
Description
-
Percentage of sperm progressive motility
-
Timepoint
-
Evaluating the percentage of sperm progressive motility before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis
6
-
Description
-
Percentage of sperm lipid peroxidation
-
Timepoint
-
Evaluating the percentage of sperm lipid peroxidation before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis
7
-
Description
-
Intensity of sperm lipid peroxidation
-
Timepoint
-
Evaluation the intensity of sperm lipid peroxidation before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis
8
-
Description
-
Percentage of sperm DNA damage index
-
Timepoint
-
Evaluating the percentage of sperm DNA damage index before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis (SCSA test)
9
-
Description
-
Percentage of sperm protamine deficiency
-
Timepoint
-
Evaluating the percentage of sperm protamine deficiency before and 80 days after probiotic administration
-
Method of measurement
-
Semen sample analysis
Intervention groups
1
-
Description
-
Intervention group: Group of patients receiving a single capsule (500 mg) of FamiLact daily (after meal). Each capsule of FamiLact contains bacterial strains of Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus bulgaricus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus and also 10⁹ CFU of Fructooligosaccharides as prebiotic. FamiLact is a product of Zist Takhmir Pharmaceutical Company, under the permission of Food and Drug department of the Ministry of Health and Medical Education (reference no.: 0347756442342525).
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: A group of patients receiving a capsule containing 500 mg of starch per day.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Artesh 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
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
-
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
-
No - There is not 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
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
Data on primary and secondary findings will be published as well as the analysis.
-
When the data will become available and for how long
-
The access will be granted 6 month after the publication
-
To whom data/document is available
-
Researchers in universities or research institutions
-
Under which criteria data/document could be used
-
Any purpose
-
From where data/document is obtainable
-
Through contacting corresponding author
-
What processes are involved for a request to access data/document
-
Contacting corresponding author through E-mail
-
Comments
-