Determining the effect of royal jelly on sperm parameters and testosterone levels in infertile men
Design
Clinical trial without control group, phase 2 per 100 patients
Settings and conduct
In this study, 100 men referred to the infertility treatment center of Imam Khomeini Hospital in Sari, Iran were studied. For this purpose, patients were first monitored for two months and after a two-month period, spermogram were performed, then for two months, they were treated with royal jelly (100 mg) daily and the parameters of sperm and level Serum testosterone will be re-evaluated after this course of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of male infertility by spermogram by kidney and urinary tract specialist (urologist)
Infertility history of more than one year
Not addiction to smoking or alcohol
Absence mass in the testicle
Exclusion criteria:
History of varicocele surgery
Taking sperm boosters in the last 2 months
Having Infectious disease
Azospermia
Having a hormonal disorder
Having a history of allergic reactions to royal jelly
Intervention groups
The intervention group includes infertile men who were first monitored for two months and after a two-month period, they underwent spermogram test, then for two months under treatment with royal jelly (100 mg made by Abaidi factory) daily 1 and sperm parameters and their testosterone levels will be re-evaluated after this treatment period.
Main outcome variables
The effectiveness of Royal Jelly on sperm parameters and testosterone levels in infertile men
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180609040028N2
Registration date:2020-07-29, 1399/05/08
Registration timing:registered_while_recruiting
Last update:2020-07-29, 1399/05/08
Update count:0
Registration date
2020-07-29, 1399/05/08
Registrant information
Name
Noushin Gordani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 1660
Email address
n.gordani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Royal Jelly on sperm parameters and Testosterone serum level of infertile men
Public title
Evaluation of the effect of royal jelly on sperm parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of male infertility by spermogram by urologist
Infertility history more than 1 year
Not addiction to smoking or alcohol
Absence of mass in Testicles
Exclusion criteria:
History of varicocele surgery
Taking sperm-boosting drugs in the last 2 months
Having a febrile infectious disease
Azospermia
Having hormonal disorders
History of allergic reactions to royal jelly
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Infertility Treatment Center, Imam Khomeini Hospital, Amir Mazandarani Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.MAZUMS.REC.1399.443
Health conditions studied
1
Description of health condition studied
Male Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Sperm parameters in spermogram test
Timepoint
2 months before the intervention and 2 months after the intervention
Method of measurement
Spermogram test
2
Description
Testosterone level
Timepoint
2 months before the intervention and 2 months after the intervention
Method of measurement
Chemiluminescence immunoassay (CLIA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infertile men are treated with royal jelly (100 mg made by Abidi factory) once a day for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Sepideh Peyvandi
Street address
Infertility Treatment Center, Imam Khomeini Hospital, Amir Mazandarani Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
dr_peyvandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Infertility Treatment Center, Imam Khomeini Hospital, Amir Mazandarani Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
dr_peyvandi@yahoo.com
Grant name
Mazandaran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Peyvandi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Treatment Center, Imam Khomeini Hospital, Amir Mazandarani Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
dr_peyvandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Peyvandi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Treatment Center, Imam Khomeini Hospital, Amir Mazandarani Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
dr_peyvandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Peyvandi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Treatment Center, Imam Khomeini Hospital, Amir Mazandarani Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
dr_peyvandi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Not applicable
Title and more details about the data/document
Only part of the data such as the original outcome information
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Other researchers can conduct further studies in this area (by sending a request email) to receive unidentifiable personal data.
From where data/document is obtainable
By sending an email request to the project executor at: dr_peyvandi@yahoo.com
What processes are involved for a request to access data/document