Protocol summary

Summary
The main objective of this study is the effect of pentoxifylline in asthenospermic infertile males ,on sperms motility and survival in culture. In a randomized unit-central clinical trial, 26 patients with sperm motility Less than 50% of progressive type or less than 25 percent of type of quickly " progressive referring to infertility clinic of Alzahra Hospital, Tabriz, Iran, will be randomly assigned to two groups, 13 patients in case group and 13 patients in control group. The patient will be excluded from study if receiving pentoxifylline orally for 9 hours before sampling. After sampling with using standard methods and Sperm separation with methods Swim up, to case group Pentoxifylline at a dose of 3.5 mmol (one mg per ml ) will be added and the control samples are examined in normal conditions. after 45 minutes, the motility and survival of sperm will be examined in both groups. Then the two samples with the same amount ( 250000 cells) 10 drop equal to 50 micro liter of the ISM1 environment. Then, after 24,36,48 hours will be checked the percentage of sperm alive and moving in two group. In this study, the primary outcome, is Sperm motility. The examiner will be unaware the intervention was carried out and this study is single blind.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201110175942N1
Registration date: 2015-06-13, 1394/03/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-13, 1394/03/23
Registrant information
Name
Aliye Ghasemzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9160
Email address
gasemzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-06-10, 1394/03/20
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pentoxifylline on motility & viability of spermatozoa from infertile asthenozoospermic males
Public title
Effect of pentoxifylline on motility & viability of spermatozoa from infertile asthenozoospermic males
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:motility of sperm <=50% or rapid progressive <25% ; sperm count<20million per milliliter exclusion criteria : Use of pentoxifylline on last 9 hour
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz university
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
-
Approval date
2010-11-09, 1389/08/18
Ethics committee reference number
5/4/6353

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
Motility of sperm
Timepoint
After 45 min,24,36,48 hour
Method of measurement
Sperm Test

Secondary outcomes

1

Description
Survival rates of sperm
Timepoint
After45 min,24,36,48 hour
Method of measurement
Sperm Test

Intervention groups

1

Description
In the intervention group: immediately to the sperm samples of pentoxifylline in the amount of 3.5 mmol (one mg per ml ) will be added.
Category
Treatment - Drugs

2

Description
In control group: samples are examined in normal conditions
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility center of alzahra hospital
Full name of responsible person
Dr.Aliye Ghasemzadeh
Street address
Alzahra hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
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
Alzahra hospital
Full name of responsible person
Dr.Aliye Ghasemzadeh
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Alzahra hospital
City
Tabriz
Postal code
-
Phone
+98 41 3557 1113
Fax
+98 41 3556 6449
Email
alghasemzadeh@yahoo.co.uk; lahroudin@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Aliye Ghasemzadeh
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Postal code
-
Phone
+98 41 3557 1113
Fax
+98 41 3556 6449
Email
alghasemzadeh@yahoo.co.uk; lahroudin@gmail.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Aliye Ghasemzadeh
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
-
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
alghasemzadeh@yahoo.co.uk; lahroudin@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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