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the effect of resistance training period with consumption of round palm and ginger supplement on serum levels of testosterone, LH and FSH ,sperm quality and DNA damage of infertile mens with Oligoasthenoteratospermia

Protocol summary

Study aim
Comparison of the effect of a resistance training course with palm and ginger pollen supplementation on serum levels of testosterone, LH, FSH, sperm quality and DFI infertile men oligoasthenoteratospermia.
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 3 on 48 patients.
Settings and conduct
This study was performed on 48 infertile men referred to Qom University Jahad Infertility Treatment Center who were divided into 6 groups: resistance training, palm pollen supplement, ginger, resistance training - palm pollen, resistance training - ginger and control. Hormones studied Before and after treatment of blood samples taken from patients using ELISA technique testosterone, LH, FSH hormones are measured and to evaluate the effect of exercise and supplements on semen quality before and after treatment, sperm analysis is performed Finally, in order to measure the effect of exercise and supplements on the DNA health of people treated in this project, SCD test before and after treatment will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile men oligoasthenoteratospermia., age 20-40 years Conditions of absence: Oligoasthenoteratospermia with sperm count less than 10 million per ml and people with underlying diseases such as cardiovascular disease, kidney disease, diabetes and severe hormonal disorders.
Intervention groups
Control group: group without supplement (placebo) Intervention group: 1- Exercise group with palm pollen supplement 2-Exercise group with ginger supplement 3. Exercise group without supplements 4- Palm pollen supplement group 5. Ginger supplement group
Main outcome variables
Correction of hormonal disorders, correction of sperm parameters, reduction of chromatin damage.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191210045681N2
Registration date: 2021-04-04, 1400/01/15
Registration timing: registered_while_recruiting

Last update: 2021-04-04, 1400/01/15
Update count: 0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
elham asa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3270 3987
Email address
asa@acecr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of resistance training period with consumption of round palm and ginger supplement on serum levels of testosterone, LH and FSH ,sperm quality and DNA damage of infertile mens with Oligoasthenoteratospermia
Public title
Improvement of sperm parameters in men with oligoasthenoteratospermia by resistance training with palm or ginger pollen supplementation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile men with oligoasthenoteratospermia Age between 20-40 years
Exclusion criteria:
Oligosthenoteratospermia with sperm count less than 10 million per ml People with underlying diseases such as cardiovascular disease, kidney disease, diabetes and severe hormonal disorders
Age
From 20 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Restricted randomization method was used.In this method it is supposed to be in one Colored glass with 48 balls with numbers 1 to 48 and For each patient by chance and draw a ball with an even number or be assigned person. Patients with even number in the treatment group and with number Individuals in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The urologist is Fully Informed about the palm or ginger Medication by Plan Holder, and the Benefits and Side Effects of the Drug are Reported to the urologist. Patients who have Entered the Study with Full Consent but have no Knowledge of Control or Intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University
Street address
No 13,Floor 4, Nilofar unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave
City
Qom
Province
Ghoum
Postal code
3713139476
Approval date
2021-01-25, 1399/11/06
Ethics committee reference number
IR.QOM.REC.1399.o28

Health conditions studied

1

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

Primary outcomes

1

Description
sperm parameter, chromatin integrity, hormone levels of LH,FSH,Testosterone
Timepoint
At the beginning of the study and 8 weeks after starting the supplement and doing exercise
Method of measurement
Sperm parameters by light microscopy, chromatin health by halo sperm test and hormones by ELISA test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Ginger supplement group: During the period 500 mg of ginger supplement with a dose of two daily 2: Palm pollen supplement group: Palm pollen supplement with a dose of 100 mg twice in the morning and afternoon 3: Exercise group, 4: Ginger supplement group With exercise 5: Palm pollen group with exercise
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qom University Jahad Infertility Treatment Center
Full name of responsible person
elham asa
Street address
No 13,Floor 4, Nilofar unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave
City
Qom
Province
Ghoum
Postal code
3713139476
Phone
+98 25 3270 3987
Email
asa.elham@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
leila naser poor
Street address
Shahid Karimi Blvd., Ishar Town, Shabnam St., Qom University Jihad Infertility Center
City
Qom
Province
Ghoum
Postal code
37131899934
Phone
+98 25 3270 0155
Email
leilanasery@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Elham Asa
Position
Embryologist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No 13,Floor 4, Nilofar unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave
City
QOM
Province
Ghoum
Postal code
3713139476
Phone
+98 25 3270 3987
Email
asa.elham@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Elham Asa
Position
Embryologist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No 13,Floor 4, Nilofar unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave
City
QOM
Province
Ghoum
Postal code
3713139476
Phone
+98 25 3270 3987
Email
asa.elham@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Elham Asa
Position
embryologist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No 13,Floor 4, Nilofar unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave
City
QOm
Province
Ghoum
Postal code
3713139476
Phone
+98 25 3270 3987
Email
asa.elham@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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