Protocol summary

Study aim
Investigating the effect of omega-3 supplement treatment on the spermogram disorder of infertile men, including the recovery rate of seminal fluid volume, sperm count, sperm motility rate, and sperm shape.
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 58 patients. Randomized permutation block method was used for randomization.
Settings and conduct
After fully explaining the research plan and obtaining informed consent, infertile men with spermogram disorders referring to the treatment clinics of Ghaem Hospital in Mashhad are included in the study. After examining the exclusion criteria, the patients are divided into two groups. In the control group, in addition to the necessary and routine treatments, a placebo is useddaily for 3 months. In the intervention group, in addition to the routine treatment, oral omega-3 treatment with a dose of 1000 mg per day is performed for 3 months. Three months after the start of the study, new spermograms will be performed in both groups and will be compared and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile men aged 20-45 years not taking Omega 3 supplements in the last 6 months Exclusion criteria: The presence of underlying disease disrupting spermogram Smoking and alcohol consumption Occupations related to high temperatures
Intervention groups
In the control group, in addition to the necessary and routine treatments to improve the spermogram disorder, a placebo is used daily for 3 months. In the intervention group, in addition to the routine treatment, oral omega-3 treatment with a dose of 1000 mg per day is performed for 3 months.
Main outcome variables
The volume of seminal fluid, the number and concentration of sperm, the amount of sperm movement and the amount of normal morphology of sperm at the beginning and 3 months after consuming omega-3.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230403057812N1
Registration date: 2023-06-10, 1402/03/20
Registration timing: prospective

Last update: 2023-06-10, 1402/03/20
Update count: 0
Registration date
2023-06-10, 1402/03/20
Registrant information
Name
Niki Taziki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3255 6218
Email address
tazikin951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega-3 supplementation on semen profile (semen volume, sperm count, sperm motility, sperm morphology) in infertile men
Public title
Omega-3 supplementation in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile men aged 20-45 years with abnormal spermogram Not taking omega 3 supplements in the last 6 months
Exclusion criteria:
Presence of known underlying disease for spermogram disorder Smoking and alcohol consumption Having jobs where there is a possibility of damage to sperm DNA due to high temperature
Age
From 20 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be determined by random block method with blocks of 4 and using random numbers table of Random Allocation Software. Blocking and allocation sequence for concealment will be done by a person not involved in the research. Allocation ratio of samples will be 1:1 and they will be placed in two groups. Then, based on the obtained blocks and according to the allocation sequence, the drugs will be given to the patients. The method is that we determine the number of blocks according to the sample size. Each block is numbered and is used for 4 patients. For example, if block number 2 is selected and its treatment group is ABAB, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment A, and the fourth patient will receive treatment B.
Blinding (investigator's opinion)
Single blinded
Blinding description
After obtaining consent, the patients are included in the study and then they are divided into two control and intervention groups. Because the patients of the control group receive placebo, the intervention and control groups will not be distinguishable. Medicine and placebo are completely similar to each other in terms of shape, color and route of administration.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.162

Health conditions studied

1

Description of health condition studied
male infertility
ICD-10 code
N46.1
ICD-10 code description
Oligospermia

Primary outcomes

1

Description
Spermogram disorders (semen fluid volume, sperm count, sperm movement rate, sperm shape)
Timepoint
At the beginning of the study, the spermogram sample is examined, and then after three months of daily consumption of omega-3 tablets, the spermogram sample is examined again.
Method of measurement
Sperm sample analyzer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in this group, in addition to routine treatment, oral omega-3 treatment with a dose of 1000 mg per day is performed for 3 months. According to the time period of spermatogenesis (about 74 days) and previous studies, the treatment time with Omega 3 supplement was three months and its dose was considered to be 1000 mg daily. Due to the different dose of docosahexaenoic acid (DHA) in omega 3 thousand mg supplements available in Iran, for all patients, an omega 3 supplement containing the same amount of DHA (about 465 mg) is used. In this study, the capsule made by Karen company is used.
Category
Treatment - Drugs

2

Description
Control group: in the control group, in addition to the necessary and routine treatments to improve the spermogram disorder, a placebo is used daily for three months. Placebo capsule is prepared from Tasnim company.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Bagher Soleimani
Street address
Ahmedabad St., Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayor Mobarhan
Street address
Ghoreshi Building, next to Hoyze cinema, University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Niki Taziki
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, East Gate of University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
tazikin951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Niki Taziki
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, East Gate of University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
tazikin951@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Niki Taziki
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, East Gate of University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
tazikin951@mums.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
Loading...