The aim of this study is evaluation of efficacy of phonix powder capsule on quality of sperm parameters of infertile men. Inclusion criteria is sperm count less than 20 million per mili liter; abnormal morphology; progressive motility less than 50 percent and exclusion criteria is varicocele; testicular atrophy; azoospermia; erectile dysfunction; candidate for ICSI (Intra Cytoplasmic Sperm Injection) ; consumption of alcohol; medications or opiods; unwillingness to partipate; death of the patient. Population target is patients refer to urology clinic in Shahid Mohammadi hospital. Phonix powder capsule 1 gram 4 times a day is given to the case group and the routine empirical medication is given to the control group. After 3 months, semenalysis is performed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020120895N1
Registration date:2015-11-08, 1394/08/17
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-11-08, 1394/08/17
Registrant information
Name
Soghra Fallahi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7192
Email address
lfallahi@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of efficacy of phonix powder capsule on quality of sperm parameters of infertile men
Public title
Efficacy of phonix powder capsule on quality of sperm parameters of infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sperm count less than 20 million per mili liter; abnormal morphology; progressive motility less than 50 percent. Exclusion criteria: varicocele; testicular atrophy; azoospermia; erectile dysfunction; candidate for ICSI (Intra Cytoplasmic Sperm Injection) ; consumption of alcohol; medications or opiods; unwillingness to partipate; death of the patient
Age
From 20 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences Ethics Committee
Street address
Jomhouri boulevard, Shahid Mohammdi Hospital, Department of Research and Technology
Intervention Control: Vitamin E 400 unit per day; L-Carnitine daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fertility and Infertility Research Center of Hormozgan
Full name of responsible person
Soghra Fallahi
Street address
Shahid Naser Boulevard , Shariati Hospital, Fertility and Infertility Research Center of Hormozgan
City
Bandar-e Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private
Full name of responsible person
Dr Soghra Fallahi
Street address
Jomhouri boulevard, Shahid Mohammadi Hospital, Vice Chancellor for Research of Tabriz University of Medical Sciences, Molecular Medicine Research Center
City
Bandar-e Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
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
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Soghra Fallahi
Position
Molecular Medicine PhD Candidate
Other areas of specialty/work
Street address
Shahid Naser Boulevard , Shariati Hospital, Fertility and Infertility Research Center of Hormozgan
City
Bander-e Abbas
Postal code
09173691399
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Soghra Fallahi
Position
Molecular Medicine PhD Candidate
Other areas of specialty/work
Street address
Shahid Naser Boulevard , Shariati Hospital, Fertility and Infertility Research Center of Hormozgan
City
Bander-e Abbas
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Soghra Fallahi
Position
PhD Candidate of Molecular Medicine
Other areas of specialty/work
Street address
Shahid Naser Boulevard , Shariati Hospital, Fertility and Infertility Research Center of Hormozgan
City
Bandar-e Abbas
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)