The main objective of this double-blind prospective clinical study is to evaluate the combined effects of pentoxifylline (PX)and L-carnitine in improving the quality of sperm parameters in infertile men with idiopathic(iOATS )oligoasthenoteratozoospermia and help to enhance Assisted reproductive technic (ART) rankings choice .the main inclusion criteria was infertile men with iOATS and also main exclusion criteria was infertile men with known OATS, 255 infertile men with iOAT allocated in a double-blind, placebo-controlled randomized clinical trial (DBRCT) and finally 212 men finished the study. they randomized to four groups. Group one received 400 mg PX/ and 400 mg L-carnitine twice daily , group two 400 mg PX/ and placebo twice daily , group three 400 mg L-carnitine with placebo twice daily and group four received PX placebo with L-carnitine placebo tablets twice daily for 3 months. From patients of all groups two semen samples (one before and one after intervention) were evaluated. Semen parameters of sperm concentration, total and fast progressive motility (%) and morphology (%) were analyzed for each sample and also according to quality of sperm parameters they categorized for ART procedures rates
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310131981N3
Registration date:2014-07-21, 1393/04/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-21, 1393/04/30
Registrant information
Name
Ali Asghar Ketabchi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 4348
Email address
a_ketabchi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Kerman University of Medical Siences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination use of pentoxifylline and L-carnitine on Idiopathic Oligoasthenoteratozoospermia
Public title
The effect of combination use of pentoxifylline and L-carnitine on sperm-analysis of Idiopathic Oligoasthenoteratozoospermia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :infertile men with Oligoasthenoteratozoospermia;men with age between 25- 40 years old; men without history of medical or surgery for infertility ;men with wives with ages between 20 - 35 years old and or with no known female fertility risk factors .
Exclusion criteria:infertile men with Oligoasthenoteratozoospermia with known etiologies.
Age
From 25 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
212
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Center of Kerman Medical Scienses University
Street address
kerman Medical Scienses University
City
kerman
Postal code
Approval date
2008-06-21, 1387/04/01
Ethics committee reference number
285/ 91
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
spermogram parameters change
Timepoint
after intervention
Method of measurement
spermogram
2
Description
Assissted reproductive technic rates
Timepoint
before intervention
Method of measurement
spermogram
Secondary outcomes
1
Description
spermogram improving
Timepoint
after 3 months from intervention
Method of measurement
spermogram
2
Description
qualification of Assissted reproductive technic rates
Timepoint
3 months after intervention
Method of measurement
spermogram
Intervention groups
1
Description
The intervention group one consumed orally 400 mg pentoxifylline and 400 mg L-carnitin twice daily for 3 months
Category
Treatment - Drugs
2
Description
The intervention group two consumed orally400mg pentoxifylline and placebo twice daily for 3 months
Category
Treatment - Drugs
3
Description
The intervention group three consumed orally400mg L-carnitin and placebo twice daily for 3 months
Category
Treatment - Drugs
4
Description
The control group fourth consumed orally two type placeboes twice daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center of Afzalipour Hospital
Full name of responsible person
Dr.Ali Asghar Ketabchi
Street address
Afzalipour Hospital
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Sciences University of kerman
Full name of responsible person
Dr. Hamid Najafi
Street address
Research Center of kerman Medical Sciences University
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Sciences University of kerman
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Center of kerman Medical Sciences University
Full name of responsible person
Dr.Gholamreza Sepehri
Position
Pharmacologist and Director of Kerman Medical Sciences University research center
Other areas of specialty/work
Street address
Research Center of kerman Medical Sciences University
City
kerman
Postal code
Phone
+98 34 1226 3857
Fax
Email
g_sepehri@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Center of kerman Medical Sciences University
Full name of responsible person
Ali Asghar Ketabchi
Position
Urologist ,Associate professor
Other areas of specialty/work
Street address
Medical Sciences University
City
Kerman
Postal code
Phone
+98 34 1211 4348
Fax
Email
dr.ketabchi@gmail.com ,a_ketabchi@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center of kerman Medical Sciences University
Full name of responsible person
golamreza sepehri
Position
professor of pharmacology ,Director of Research Center of kerman Medical sciences university
Other areas of specialty/work
Street address
Research Center of kerman Medical Sciences University
City
kerman
Postal code
7613747181
Phone
+98 34 1226 3857
Fax
Email
g_sepehri@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)