Protocol summary

Study aim
Determining the effect of Moringah plant powder capsule on spermogram parameters (sperm motility, sperm morphology, sperm volume, sperm, sperm viscosity, Ph, sperm concentration) before and after the study
Design
Selection of 60 male patients referred to the clinic with infertility who are eligible for the study are randomly divided into two groups (group receiving capsules containing Moringa plant and group receiving: vitamin E, L-arginine and HCG ampules. It should be noted that the randomization method is done in a block method so that the size of the blocks is taken to hide the heterogeneous state.
Settings and conduct
HOSPITAL
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Age 55-30 years - obtained informed consent - Sperm concentration below 15 million per milliliter Exclusion criteria: Lack of treatment in the last 3 months - Sperm concentration below 5 million per milliliter - Varicocele grade 3 - Diabetes - Infertility problem in a recent year
Intervention groups
Selection of 60 male patients referred to the clinic with infertility who are eligible for the study are randomly divided into two groups (group receiving capsules containing Moringa plant (3gr per day) and group receiving: vitamin E, L-arginine and HCG ampules.
Main outcome variables
Sperm motility, Sperm morphology, Sperm volume, Sperm concentration, Sperm count, Sperm viscosity, PH, Testosterone concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210209050309N1
Registration date: 2021-02-21, 1399/12/03
Registration timing: registered_while_recruiting

Last update: 2021-02-21, 1399/12/03
Update count: 0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
keshvad hedayatyanfard
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3428 7425
Email address
keshvad_tam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Moringa Oleifera plant powder on infertility in men a randomized clinical trial
Public title
Effects of Moringa Oleifera plant powder on infertility in men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age: 30-55 years old obtain informed consent Sperm concentration below 15 million per ML
Exclusion criteria:
Treatment of the disease in the last 3 months Sperm concentration below 5 million per milliliter Varicocele grade 3 Diabetes Infertility in a recent year addiction chemical therapy (cancer) Corticosteroid therapy Systemic diseases
Age
From 30 years old to 55 years old
Gender
Male
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Among the patients referred to the clinic, each patient received a code or a number, which were randomly distributed in two groups receiving herbal powder and the group receiving Chemical treatment treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
alborz university of medical sciences
Street address
alborz university of medical sciences
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.ABZUMS.REC.1399.227

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
Sperm motility, Sperm morphology, Sperm volume, Sperm concentration, Sperm count, Sperm viscosity, PH, Testosterone concentration
Timepoint
Before and after the intervention with an interval of 2 months
Method of measurement
Spermatogram

Secondary outcomes

empty

Intervention groups

1

Description
A group of 30 patients receiving capsules containing Moringa (3 grams per day) and another group of 30 receiving common treatment protocols include: Vitamin E, L-arginine and HCG ampoules.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
madani hospital
Full name of responsible person
dr.mohammad shahi
Street address
alborz university of medical sciences, school of medicine
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7339
Email
d.shahi@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
alborz university of medical sciences
Full name of responsible person
mohammad noorisepehr
Street address
safarian Ave, golshar, karaj
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
alborz university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
alborz university of medical sciences
Full name of responsible person
davood mohammad shahi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
alborz university of medical sciences, school of medicine
City
karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7425
Email
d.shahi@abzums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
alborz university of medical sciences
Full name of responsible person
keshvad hedayatyanfard
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
alborz university of medical sciences, school of medicine
City
karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7339
Email
keshvad_tam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
alborz university of medical sciences
Full name of responsible person
keshvad hedayatyanfard
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
alborz university of medical sciences, school of medicine
City
karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7339
Email
keshvad_tam@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to ethical protocols, patients' information is confidential.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only information about the main outcome of the study can be published.
When the data will become available and for how long
2021-2022
To whom data/document is available
only university researchers
Under which criteria data/document could be used
For statistical analysis
From where data/document is obtainable
authors of study
What processes are involved for a request to access data/document
Formal application letter to the university
Comments
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