The purpose of this clinical trial study was to investigate the effectiveness of oral Pentoxyfilin on the improvement of quality of sperm analysis parameters. Study participants were recruited from the patients who referred to infertility department of AlZahra hospital of Tabriz. 61 participants in this study received Pentoxyfilin, 400 mg three times a day, for three months. Outcome measures were volume of semen, sperm motility, percentage of normal morphology, and sperm count.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009094721N1
Registration date:2010-09-26, 1389/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-26, 1389/07/04
Registrant information
Name
Kamaladdin Hassanzadeh
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 1622
Email address
hassanzadehka@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Scienses
Expected recruitment start date
2001-09-23, 1380/07/01
Expected recruitment end date
2002-09-23, 1381/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Oral Pentoxifyllin On Spermogram In Olygoastenosperm Men
Public title
Effect of Oral Pentoxifyllin on Spermogram
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Men with primary infertility, having analysis of sperm before treatment, presence of olygoastenospermia
Exclusion Criteria: Contraindication of pentoxyfilin, Other medical diseases (diabetes, hypertension, …), any drug consumption
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
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
Medical Faculty Of Tabriz University Of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Approval date
empty
Ethics committee reference number
20568/4
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Male infertility, Oligospermia NOS
Primary outcomes
1
Description
Motility of sperm
Timepoint
before treatment and 3 monthes aftter treatments
Method of measurement
Percentage of sperms with mobile flagel
2
Description
volume of semen
Timepoint
3 months
Method of measurement
volume of semen in ml
3
Description
morphology of sperm
Timepoint
before treatment and 3 monthes after treatment
Method of measurement
labratory survey: 60% of sperms with normal morphology and lower than 3% immature form
4
Description
total nomber of sperms
Timepoint
before treatments and 3 months after treatment
Method of measurement
count of total sperm in microscopic field
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: oral pentoxifylin Dosage, 400 mg 3 times a day, for 3 months, oraly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Infertility Research Center
Full name of responsible person
Dr. Kamaladdin Hassanzadeh
Street address
Alzahra Research and Infertility Center, Artesh jonoobi street,
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Scienses
Full name of responsible person
Dr. Kamaladdin Hassanzadeh
Street address
Faculty of Medicine, Tabriz University of Medical Scienses, Daneshgah street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University Of Medical Scienses
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
Tabriz university Of Medical Scienses
Full name of responsible person
D. Kamaladdin Hassanzadeh
Position
Academic member of urology
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Scienses, Daneshgah street
City
Tabriz
Postal code
Iran
Phone
+98 41 1477 1622
Fax
+98 41 1336 6579
Email
drhassanzadehka@yahoop_k_hn@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Scienses
Full name of responsible person
Dr. kamaladdin hassanzadeh
Position
Assistant Professore Of Urology
Other areas of specialty/work
Street address
Urology department, Faculty of Medicine, Tabriz University of Medical Scienses, Daneshgah street
City
Tabriz
Postal code
Iran
Phone
+98 41 1477 1622
Fax
+98 41 1336 6579
Email
hassanzadehka@tbzmed.ac.irp_k_hn@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Scienses
Full name of responsible person
Parisa Yavarikia
Position
Academic member /Msc
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty, Shariati jonoobi street
City
Tabriz
Postal code
Iran
Phone
+98 41 1477 1622
Fax
+98 41 1336 6579
Email
p_k_hn@yahoo.comyavarikiap@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)