The aim of this study was to evaluate the effectiveness of Taroneh on sperm parameters of infertile men and comparison with the drug pentoxifylline. This study was a single-center, randomized, single-blind and phase III trial that will be performed on 80 infertile men with idiopathic oligoasthenoteratospermia. In this study patients were randomly using a tablet of divided in two groups: 40 people in the control group and 40 people in the intervention group. A spermogram will be done in the beginning of study. The intervention group was received 6 gr powder of sachet of Taroneh in two divided doses (3 gr every 12 hours) for 90 days. The control group was given daily 400 mg pentoxifylline tablet for 90 days. A blind assessment of spermogram will be done again 1 month after the end of treatment period.
The evaluation of study is based on spermogram and the third party
doesn’t know anything about patients especially the drugs that patients have received so the evaluation is
blind and this study is considered a single blind clinical trial.
Inclusion criteria: Idiopathic Oligospermia; Idiopathic asthenospermia; Idiopathic teratospermia; Absence of azoospermia;Non-consuming use
of other drug for treatment of infertility, Exclusion criteria: the incidence of serious side effects.
primary outcomes: Total number of sperms; Number of sperms in each ml of semen; Sperms motivation speed; Morphology
Secondary outcomes: Semen volume; Viscosity; Reaction of upper respiratory tract to Taroneh.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111519965N1
Registration date:2016-02-19, 1394/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-19, 1394/11/30
Registrant information
Name
Mohammadreza Mirzaei Hargalan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5596 0044
Email address
mirzaei-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Tehran University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate of effectiveness of Taroneh (traditional medicine product) on sperm parameters of infertile men and comparison with the drug pentoxifylline
Public title
Effect of Taroneh on treatment of male infertillity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Idiopathic oligospermia; Idiopathic Asthenospermia; Idiopathic Teratospermia; Idiopathic Oligoasthenospermia; Idiopathic Oligoteratospermia; Idiopathic Oligoteratoasthenospermia; 18-35 Age; Patient’s wife age 18-35; Absence of azoospermia; Non-consuming use of other drug for
treatment of infertility during the study
Exclusion criteria: lack of patient cooperation; the incidence of
serious side effects, Age more than 35, Age of patient’s spouse more than 35
Age
From 18 years old to 35 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done by random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Keshavarz Ave, Tehran
City
Tehran
Postal code
Approval date
2015-05-10, 1394/02/20
Ethics committee reference number
IR.TUMS.REC.1394.146559
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 count concentration
Timepoint
Before intervention and then four months after the start of intervention (one month after the end of intervention)
Method of measurement
Semen analysis
2
Description
Total sperm count
Timepoint
Before intervention and then four months after the start of intervention (one month after the end of intervention)
Method of measurement
Semen analysis
3
Description
Motility
Timepoint
Before intervention and then four months after the start of intervention (one month after the end of intervention)
Method of measurement
Semen analysis
4
Description
Morphology
Timepoint
Before intervention and then four months after the start of intervention (one month after the end of intervention)
Method of measurement
Semen analysis
Secondary outcomes
1
Description
Upper respiratory tract's reaction to Taroneh.
Timepoint
When the incidence of adverse drug reactions in patient
Method of measurement
According CTC (Common Toxicity Criteria)
2
Description
Volume
Timepoint
Before intervention and then four months after the start of intervention (one month after the end of intervention)
Method of measurement
Semen analysis
3
Description
Viscosity
Timepoint
Before intervention and then four months after the start of intervention (one month after the end of intervention)
Method of measurement
Semen analysis
Intervention groups
1
Description
Intervention Group: 3 gram powder of Taroneh in sachet, twice a day for 90 day
Taroneh will purchase from south groves of Iran
Category
Treatment - Drugs
2
Description
Control Group: one tablet of Pentoxifyilline (400mg) (Farabi pharmaceutical company) daily for 90 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Jasmine lover of women`s hospital
Full name of responsible person
Dr. Firozeh Akbari
Street address
The end of Ostad nejatollahi shomali street, karimkhan zand street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Roja Rahimi
Street address
College of Traditional Medicine of Tehran University of Medical, Behesht Street, Vahdat Eslami Street
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Mirzaei
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
College of Traditional Medicine of Tehran University of Medical Sciences, Behesht Street, Vahdat Eslami Street
City
Tehran
Postal code
Phone
+98 21 5563 9724
Fax
Email
mirzaei-m@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Mirzaei
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
College of Traditional Medicine of Tehran University of Medical Sciences, Behesht Street, Vahdat Eslami Street
City
Tehran
Postal code
Phone
+98 21 5563 9724
Fax
Email
mirzaei-m@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Mirzaei
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
College of Traditional Medicine of Tehran University of Medical Sciences, Behesht Street, Vahdat Eslami Street
City
Tehran
Postal code
Phone
+98 21 5563 9724
Fax
Email
mirzaei-m@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)