Effect of Curcumin Nanomicelle on Semen Parameters, Oxidative Stress, and Reproductive Hormones in Varicocele Men
Design
Clinical Trial with Control Group with Parallel Groups, Two-way Blind, Randomized, The Study Phase does not Apply, in this Simple Individual Randomization Study Using Software The Rendering is Done.
Settings and conduct
In the Intervention Group of Varicocele Patients Treated with the Curcumin Nanomicelle Drug 80 mg Daily for 10 Weeks were Blood and Fluid Serum Samples Semen is Taken From them After Taking the Drug. In this Study, Both Researchers and Participants became Blind and the Study Site is the Qom University Jahad Infertility Center.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Infertile Men with Varicocele
Conditions of Absence: Men with ( Systemic Disease or Taking Medication For Systemic Disease, History of Chemotherapy or Radiation Therapy, Treatment with Anti-Inflammatory Drugs Depression)
Intervention groups
The Intervention Group, which Received 80 mg of Curcumin Nanomicelle Daily, and the Control Group, which Received a Placebo for 10 Weeks.
Main outcome variables
Semen Parameters, Sex Hormones, Stress
Oxidative Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170923036334N3
Registration date:2022-05-07, 1401/02/17
Registration timing:registered_while_recruiting
Last update:2022-05-07, 1401/02/17
Update count:0
Registration date
2022-05-07, 1401/02/17
Registrant information
Name
Atefeh Verdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3291 7757
Email address
verdi@acecr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Curcumin Nanomicelle on Semen Parameters, Oxidative Stress, and Reproductive Hormones in Varicocele Men
Public title
Modification of Complications in Infertile Men with Varicocele by Curcumin Nanomicels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile Men with Varicocele
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this Study Simple Individual Randomization Using Software
The Rendering is Done.
Blinding (investigator's opinion)
Double blinded
Blinding description
Urologist by the Project Manager about the Drug Nanocell Curcumin
He was Fully Informed and Informed about the Properties and Side Effects of the Drug Placement of Patients in the Control and Treatment Group is the Responsibility of the Urologist Be Patients who have Entered the Plan with Full Consent but are Informed of the Appointment There is no Control or Treatment in the Control Group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Mashhad University Jahad
Street address
No 13,Floor 4, Nilofar Unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave
City
Qom
Province
Ghoum
Postal code
3713133483
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.ACECR.JDM.REC.1400.082
Health conditions studied
1
Description of health condition studied
Varicocele
ICD-10 code
I86.1
ICD-10 code description
Scrotal varices
Primary outcomes
1
Description
Serum Levels of Sex Hormones
Timepoint
Before Taking the Drug and 10 Weeks After Taking the Drug
Method of measurement
Eliza Kit
2
Description
Sperm Parameters
Timepoint
Before Taking the Drug and 10 Weeks After Taking the Drug
Method of measurement
Standard Clinical Analysis of Semen for Evaluation of Sperm Parameters with The Usual Laboratory Method and Light Microscope According to the Organization CriteriaWHO-2010 World Health Takes Place.
3
Description
Oxidative Stress Rate
Timepoint
Before Taking the Drug and 10 Weeks After Taking the Drug
Method of measurement
ROS Positive Sperms were Evaluated Using H2DCFDA (DCFH - DA: 2 ', 7'-dichlorodihydrofluoresceindiacetat) (Sigma Co., USA) and Analyzed by Flow Cytometry.
Secondary outcomes
1
Description
Viability
Timepoint
Before Taking the Drug and 10 Weeks After Taking the Drug
Method of measurement
Viability is Assessed by Eosin-Nigrosin Staining and Examined Using a Light Microscope.
2
Description
DNA Damage Assessment
Timepoint
Before Taking the Drug and 10 Weeks After Taking the Drug
Method of measurement
Tunnel Kit
3
Description
Measurement of Sperm Mitochondrial Activity
Timepoint
Before Taking the Drug and 10 Weeks After Taking the Drug
Method of measurement
Rhodamine Staining is Used to Assess the Mitochondrial Activity of Sperm.
Intervention groups
1
Description
Intervention Group:In the Intervention Group of Varicocele Patients Who were Treated with Nano-micelles Curcumin 80 mg Daily for 10 Weeks, Serum and Semen Samples were Taken from them After Taking the Drug.
Category
Treatment - Drugs
2
Description
Control group: In the Control Group of Varicocele Patients who Received Placebo for 10 Weeks, Blood Serum and Semen Samples were Taken After Taking the Drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom University Jahad Infertility Treatment Center
Full name of responsible person
Rahil Janati Far
Street address
No 13,Floor 4, Nilofar Unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave
City
Qom
Province
Ghoum
Postal code
3713133483
Phone
+98 25 3270 0155
Email
rahiljanati2016@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 Pour
Street address
No 13,Floor 4, Nilofar Unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave
City
Qom
Province
Ghoum
Postal code
3713133483
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
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
Iranian academic center for education culture and research
Full name of responsible person
Atefeh Verdi
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
3713133483
Phone
+98 25 3270 0155
Email
Atefeh.Verdi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Rahil Jannatifar
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
3713133483
Phone
+98 25 3270 0155
Email
rahiljanati2016@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
Atefeh Verdi
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
3713133483
Phone
+98 25 3270 0155
Email
Atefeh.Verdi@yahoo.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Its Release Schedule is not Yet Known.
When the data will become available and for how long
6 Months After Printing the Results.
To whom data/document is available
Researchers Working in Academic and Scientific Institutions.
Under which criteria data/document could be used
Provide Detailed Information to the Urologist for Treatment
Infertility and Patient Well-being.