Determine the efficacy of supplement with L-carnitine on semen parameters
Design
To implement this project, all patients with male infertility referred to Infertility Clinic of Ayatollah Taleghani Hospital have been investigated and Based on inclusion and exclusion criteria were selected and matched for age and BMI.
Settings and conduct
To implement this project, all patients with male infertility referred to Infertility Clinic of Ayatollah Taleghani Hospital have been investigated and Based on inclusion and exclusion criteria were selected and matched for age and BMI. After entering the plan, the semen analysis is first taken from the reference laboratory.For 3 months, Androferti is prescribed as a drug that is higher than the L-carnitine dose than the usual antioxidants. After three months, patients are called by infertility colleagues and sperm analysis is performed again and the results are compared with the initial test.
Participants/Inclusion and exclusion criteria
Infertile men between 20-45 years old with idiopathic oligoasthenoteratospermia, BMI less than 30, No smoking and drug, Lack of azoospermia
Unwillingness to participate in the design or continuation of the treatment process, Drug intolerance
Intervention groups
Total infertile men with idiopathic oligoasthenospermia treated by L-carnitine supplement twice orally daily
Main outcome variables
Changing the count, motility and normal morphology in semen analysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190426043379N1
Registration date:2019-06-16, 1398/03/26
Registration timing:registered_while_recruiting
Last update:2019-06-16, 1398/03/26
Update count:0
Registration date
2019-06-16, 1398/03/26
Registrant information
Name
Ferdoos Jahanmardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6604 9733
Email address
f.jahanmardi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-31, 1398/03/10
Expected recruitment end date
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of antioxidant with high dose L-carnitine on count, morphology and motility in infertile patients semen analysis
Public title
Effects of high dose L-carnitine on semen parameter in infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 45 years
BMI less than 30
No smoking and drug
Lack of azoospermia
Sperm count is less than 15 million
Sperm motility less than 32%
Normal morphology less than 4%
Exclusion criteria:
Unwillingness to participate in the design or continuation of the treatment process
Drug intolerance
Age
From 20 years old to 40 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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 Shahid Beheshti Univercity of medical Sciences
Street address
Arabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1359
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Sperm count less than 15 million
Timepoint
Beginning of the project and after three months
Method of measurement
Laboratory
2
Description
Sperm motility less than 32%
Timepoint
Beginning of the project and after three months
Method of measurement
Laboratory
3
Description
Normal morphology less than 4%
Timepoint
Beginning of the project and after three months
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients with male factor infertility receive Androferti as a drug with high dose L-Carnitine for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Ferdoos Jahanmardi
Street address
Arabi street, Velenjak, Tehan
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zarghi Afshin
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Prevention of gynecological Research Center (66000104)
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Salehpour Saghar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arabi srteet, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
S_Salehpour@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Salehpour Saghar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arabi srteet, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
S_Salehpour@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ferdoos Jahanmardi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi2
City
Tehran
Province
Tehran
Postal code
1459913841
Phone
+98 21 6604 9733
Fax
Email
f.jahanmardi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Methodology, statistical analysis
When the data will become available and for how long
Starting available 6 months after the publication of results
To whom data/document is available
Researchers working in academic and scientific institutions and individuals who are working in industry
Under which criteria data/document could be used
For similar research, new research collaboration
From where data/document is obtainable
Corresponding Author Email Address
What processes are involved for a request to access data/document