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Investigation the effect of modified diet on semen factors in men with idiopathic infertility: A randomized clinical trial

Protocol summary

Study aim
Determining the effect of modified diet on semen factors in men with idiopathic infertility
Design
A randomized, controlled, parallel-group, unblinded clinical trial on 66 patients. The codes of Random Allocation Software (RAS) were used for randomization.
Settings and conduct
Eligible patients referred to Mehr infertility treatment center (Rasht, Gilan) are randomly divided into two groups of 33: intervention and control. The food record questionnaire to measure and control macronutrients intake in the diet, and physical activity record to calculate the energy expenditure will be evaluated in beginning and every two weeks during the study. Ten milliliter fasting blood and semen samples after 2-3 days of sexual abstinence will be taken from all subjects at the beginning and end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Oligoasthenoteratozoospermic men aged 20 to 45 years with semen volume > 1.5 ml, BMI equal to 18.5-30, normal testicular volume, normal karyotype and normal levels of FSH, LH and prolactin will be included in the study. And exclusion criteria: consumption of tobacco, alcohol and drugs in the last three months, Y-chromosome microdeletion, more than 25% DNA fragmentation rate, following any special diet during the last three months, taking multivitamin and mineral supplements during the last three months, the presence of uncontrolled inflammatory and chronic diseases such as diabetes, hypothyroidism, history of cancer or pelvic chemotherapy or radiotherapy, untreated varicocele, and prostatitis.
Intervention groups
The control group will be given a diet based on height and weight with the modification of the percentage of macronutrients, and for the intervention group, a diet for fertility improvement will be designed according to the individual's height and weight.
Main outcome variables
Semen analysis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230514058181N1
Registration date: 2023-05-24, 1402/03/03
Registration timing: prospective

Last update: 2023-05-24, 1402/03/03
Update count: 0
Registration date
2023-05-24, 1402/03/03
Registrant information
Name
Fatemeh Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
ftaheri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-01, 1402/03/11
Expected recruitment end date
2024-05-31, 1403/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of modified diet on semen factors in men with idiopathic infertility: A randomized clinical trial
Public title
Investigation the effect of modified diet on semen factors in men with idiopathic infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 45 years Semen volume > 1.5 ml BMI of 18.5-30 Normal testicular volume Normal karyotype Normal level of LH, FSH and prolactin
Exclusion criteria:
Consumption of tobacco, alcohol and drugs in the last three months Y-chromosome microdeletion More than 25% DNA fragmentation rate Following any special diet during the last three months Taking multivitamin and mineral supplements during the last three months The presence of uncontrolled inflammatory and chronic diseases such as diabetes and hypothyroidism History of cancer or pelvic chemotherapy or radiotherapy Untreated varicocele Prostatitis
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization method is used to randomly assign participants into two groups. At first, the randomization sequence based on blocks of 2 and 4 is randomly determined using the software codes of RAS: Random Allocation Software. Then, the eligible people included in the study will be assigned to one of the two groups based on the randomization sequence.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gilan University of Medical Sciences (Research Ethics Committee)
Street address
Department of Research and Technology of Gilan University of Medical Sciences, in front of 17 Shahrivar Hospital, Shahid Siyadati St., Namjo St.
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.GUMS.REC.1402.034

Health conditions studied

1

Description of health condition studied
Idiopathic oligoasthenoteratozoospermia
ICD-10 code
N46.9
ICD-10 code description
Male infertility, unspecified

Primary outcomes

1

Description
Semen analysis
Timepoint
The beginning and end of the study
Method of measurement
A combination of two eye methods and computer software

Secondary outcomes

1

Description
Malondialdehyde
Timepoint
The beginning and end of the study
Method of measurement
ELISA

2

Description
Testosterone
Timepoint
The beginning and end of the study
Method of measurement
ELISA

Intervention groups

1

Description
Intervention group: For the intervention group, a fertility-improving diet is designed according to the person's height and weight, with an emphasis on effective foods such as saffron, omega-3, and consuming more vegetable proteins than animal proteins within the permissible limits set for each person.
Category
Treatment - Other

2

Description
Control group: The amount of calories and the percentage of macronutrients are determined based on the Mifflin formula according to their height, weight and physical activity and the range of acceptable distribution of macronutrients for each person.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr infertility treatment center
Full name of responsible person
Marziye Mehr Afza
Street address
Mehr infertility treatment center, Irshad St., Shahid Ansari Boulevard
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3375 5353
Email
elmira.hosseinzadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mehr infertility treatment center
Full name of responsible person
Marziye Mehr Afza
Street address
Mehr infertility treatment center, Irshad St., Shahid Ansari Boulevard
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3375 5353
Email
elmira.hosseinzadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mehr infertility treatment center
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elaheh Honarkar-Shafie
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 2296 7613
Email
elahehhonarkar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elaheh Honarkar-Shafie
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 2296 7613
Email
elahehhonarkar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elaheh Honarkar-Shafie
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 2296 7613
Email
elahehhonarkar@yahoo.com

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
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