Evaluation of the Antioxidant Role of Palm Pollen in Oligospermic and Asthenozoospermic Men and Its Correlation with Count, Motility and Morphology of the Sperm
Objectives: To examine the effects of Mogza herbal capsules on count, motility and morphology of sperms and expression of antioxidant genes in them. Design: Participants are divided into two groups by permutation randomization method: control group (who are received standard male infertility drug prescribed by physican) and case group (who are received researcher's drug as Mogza in addition to standard male infertility drug prescribed by physican). Members of both groups are trained to go walking for 20 minutes as callisthenics, three times a week. According to the list given to them, they should follow a special diet, including a plate of vegetables, certain amounts and kinds of fruits in a week and a ban on fastfood consumption, etc. Setting and conduct: Semen samples are collected by masturbation in two to four days after their last sexual intercourse and are divided into three groups. Semen analysis are conducted on the first group immediately and in the other group, semen samples are stored in separate 1 ml tubes (which are free of DNAse and RNAse) in nitrogen tank in -80°C, to do further molecular tests (DNA extraction and anti oxidant gene expression) and measurements of semen enzymes activities. In third group, free levels of F2t Isoprostane in plasma are measured by ELISA method, using Caymann Chemical and Ann Arbor commercial kits. Participants: Oligospermic and asthenospermic patients in the age ranges of 20-40 years with normal genital anatomy (after necessary lab tests by Urology specialist) who are referred to IVF Center of Om Leila hospital are chosen by researcher-made checklist. Individuals with varicocele, prostatitis, epidimitis, orchidism, mumps, testicular trauma, hyperthyroidism, hypothyroisdism, diabetes, thalassemia major, genetic disorders affecting infertility, history of hernia surgery, vasectomy and who are consume antioxidant drugs, are excluded from study. Interventions: Four gram palm pollen are consumed daily in case groups as 1 gram Mogza capsules (two capsules in the morning and two capsules at night, one hour after meal) for two and a half months. Variables of main outcome: Count, motility and morphology of sperms and expression of antioxidant genes (SOD, CAT, GPX, NRF2 and KEAP1) in them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020120895N2
Registration date:2015-10-12, 1394/07/20
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-10-12, 1394/07/20
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
Vice chancellor for research, Hormozgan University of Medical Sciences
Expected recruitment start date
2015-03-22, 1394/01/02
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Antioxidant Role of Palm Pollen in Oligospermic and Asthenozoospermic Men and Its Correlation with Count, Motility and Morphology of the Sperm
Public title
Evaluation of the Antioxidant Role of Palm Pollen in Oligospermic and Asthenozoospermic Men and Its Correlation with Characteristics of Spermatozoa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Normal genital anatomy; infertility due to oligo and asthernospermia
Exclusion Criteria:
Genital infection during the study; systemic medication for other infections; intake of dietary supplements 3 months before study; positive history of contact with chemical substances, solvents and inorganic substances; specimens from subjects with known etiology (varicocele, cryptorchidism, urinary tract infection, trauma, chemotherapy and etc.); individuals younger than 20 years or older than 40 years old; Individuals with varicocele; prostatitis; epidimitis; orchidism; mumps; testicular trauma; hyperthyroidism; hypothyroisdism; diabetes; thalassemia major; genetic disorders affecting infertility (Klinefelter , Noonan syndrome , microdeletion of chromosome Y, the mitochondrial DNA mutations); histotry of hernia surgery; vasectomy; consumption of antioxidant drugs
Age
From 20 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics Committee of Molecular Medicine Research Center
Street address
Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
City
Bandar Abbas
Postal code
7915915517
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
HEC-93-12-4
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Azoospermia NOS Oligospermia NOS
Primary outcomes
1
Description
Evaluation of count, motility and morphology of sperm
Timepoint
10 months
Method of measurement
RT-PCR and Semen analysis
2
Description
Evaluation of expression of antioxidant SOD, CAT, GPX, NRF2 and KEAP1 genes
Timepoint
10 months
Method of measurement
RT-PCR and Semen analysis
Secondary outcomes
1
Description
Evaluation the levels of 8-Isoprostane and free radicals metabolites
Timepoint
3 months after consumption of palm pollen
Method of measurement
RT-PCR, molecular and biochemical tests
Intervention groups
1
Description
Control group: They are received only the standard male infertility drug prescribed by Urologists.
Category
Treatment - Drugs
2
Description
Case group: They are received 4 gram palm pollen as 1 gram Mogza capsules (two capsules in the morning and two capsules at night, one hour after meal) in addition to standard male infertility drug prescribed by Urologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Molecular Medicine of Shahid Mohammadi Hospital
Full name of responsible person
Dr Soghra Fallahi
Street address
Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
City
Bandar Abbas
2
Recruitment center
Name of recruitment center
Oom Leila IVF Center
Full name of responsible person
Dr Soghra Fallahi
Street address
Oom Leila Hospital, Behind Seyyed Mozaffar Shine, Jomhouri Eslami Blv, Bandar Abbas
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hormozgan University of Medical Sciences
Full name of responsible person
Dr Soghra Fallahi
Street address
Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
City
Bandar Abbas
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, Hormozgan 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
Research Center for Molecular Medicine of Shahid Mohammadi Hospital
Full name of responsible person
Dr Soghra Fallahi
Position
PhD Student Research of Molecular Medicine
Other areas of specialty/work
Street address
Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
City
Bandar Abbas
Postal code
7915915517
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
Research Center for Molecular Medicine of Shahid Mohammadi Hospital
Full name of responsible person
Dr Soghra Fallahi
Position
PhD Student of Research in Molecular Medicine
Other areas of specialty/work
Street address
Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
City
Bandar Abbas
Postal code
7915915517
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
Research Center for Molecular Medicine of Shahid Mohammadi Hospital
Full name of responsible person
Dr Soghra Fallahi
Position
PhD Student of Research in Molecular Medicine
Other areas of specialty/work
Street address
Laboratory of Molecular Medicine, Ground Floor, Vice chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas
City
Bandar Abbas
Postal code
7915915517
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)