Effect of quercetin on the inflammatory factors NfKb, TnfAlpha, Il6 and expression of the Nrf2 and Keap1 genes in poly cystic ovary syndrome (PCOS Patients)
All standard treatment for PCOS patients done , the only difference is consumption of Quercetin tablets or placebo
Settings and conduct
Blood samples are taken from patients in the beginning of menstruation(The blood sample is immediately centrifuged and the resulting serum is stored at an appropriate temperature of -20 ° C). Then consuming a dose of 500 mg per day of Quercetin in the intervention group or placebo in the control group will start. After 40 days, on the day of ovulation, the blood sample is taken again. After puncture surgery the granulosa cells are isolated and cultured. Finally by using PCR , the expression of Nrf2 and Keap1 genes in mentioned granulosa cells studied.
Participants/Inclusion and exclusion criteria
In this study, after confirmation of diagnosis (PCOS) in patients based on Rotterdam criteria, candidates for in vitro fertilization (IVF) are admitted to the study by below criterions.
Inclusion:
-Has an infertility problem
-Infection with confirmed PCOS with hyperandrogenism
-Age between 20 to 37 years
-Mild to moderate male factor
-Accompanying female infertility factors are tubal or infertility of unknown origin.
Exclusion:
-FSH higher than 10
-Hyperprolactinemia, thyroid disease
-Receive any ocp, hormonal treatments in the last trimester
Intervention groups
Intervention in the intervention group: administration of quercetin QUR supplement, in the amount of 500 mg daily oral capsules, for 40 days from the first day of the menstrual cycle to the day of follicle recovery.
Intervention in the control group: administration of quercetin QUR placebo, in the amount of 500 mg daily capsules, for 40 days from the first day of the menstrual cycle to the day of follicle recovery from patients.
Main outcome variables
Effects on inflamatory factors of TNFalpha, Nfkb, IL6
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210516051323N1
Registration date:2021-11-16, 1400/08/25
Registration timing:registered_while_recruiting
Last update:2021-11-16, 1400/08/25
Update count:0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Sima Vaez
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4022 8954
Email address
vaezmrs@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of quercetin on the inflammatory factors NfKb, TnfAlpha, Il6 and expression of the Nrf2 and Keap1 genes in poly cystic ovary syndrome (PCOS Patients)
Public title
Effect of Quercetin on PCOS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility with documented PCOS & Hyperandrogenism;20-37Y/O; Candidate for IVF Cycle; If have male factor; it must mild to moderate form, not non-obstructive azospermia; If have other female factor; only cervical & tubal factors are acceptable.
Exclusion criteria:
Age
From 20 years old to 37 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
Two blood sample + one follicular sample
Randomization (investigator's opinion)
Randomized
Randomization description
(Block Randomization) 42 patients are randomly assigned to the intervention and control groups by blocking method, and each for a period of 40 days from the beginning of the menstrual cycle to the day of ovulation, will receive a daily dose of 500 mg of quercetin for the intervention group or a placebo for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done by assigning a number to each patient. Quercetin and placebo capsules are the same. A person who is not involved in the study prepares the containers of both groups by placing quercetin and placebo tablets in the same containers and assigning codes. Both researchers and study participants are blind from the time of randomization to the time of data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of islamic azad university science and research branch Tehran
Street address
Daneshgah Sq, North end sattari Exw, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.IAU.SRB.REC.1399.213
Health conditions studied
1
Description of health condition studied
Poly Cystic Ovary Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Inflamatory factors TNfAlpha, IL6
Timepoint
Before consumption and after puncture surgery
Method of measurement
Elaysa Test on blood sample
Secondary outcomes
1
Description
Effects on expression of Nrf2-Keap1 genes
Timepoint
After puncture surgery
Method of measurement
Real Time PCR Device records
2
Description
Protein expression, Keap-1
Timepoint
After the intervention
Method of measurement
western blot
Intervention groups
1
Description
For Intervention Group: quercetin, Orally 500 mg/day (1 Cap.) for 40 days from the beginning of the menstruation cycle till oocyte retrieval.
Category
Placebo
2
Description
Intervention group: Placebo of quercetin, Orally 1 Cap. for 40 days from the beginning of the menstruation cycle till oocyte retrieval.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Hospital Tehran
Full name of responsible person
Sima Vaez
Street address
Arash Hosp, Baghdarnia St, Tehranpars
City
Tehran
Province
Tehran
Postal code
1653959469
Phone
+98 21 7788 3283
Email
hosp_arash@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kazem Parivar
Street address
North sattari , Daneshgah Sq. SRBIAU
City
Teharn
Province
Tehran
Postal code
14778938551
Phone
+98 21 4486 5154
Email
basic-fa@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Sima Vaez
Position
Student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
unit3 no53 pabarja st shariati st Tehran
City
Tehran
Province
Tehran
Postal code
1949635771
Phone
+98 21 4022 8954
Email
vaezmrs@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
kazem parivar
Position
ph.D in Animal Developmental Cell Biology
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Tehran,The end of Shahid Sattari Highway ,University Square of Shohada Hesarak Boulevard ,Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Fax
Email
basic-fa@srbiau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sima Vaez
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Shariati St, Pabarja No53 U3
City
Tehran
Province
Tehran
Postal code
1949635771
Phone
+98 21 4022 8954
Fax
Email
vaezmrs@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the participants data related to main topic of research
When the data will become available and for how long
6 months after first formal issue
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
Written Approval
From where data/document is obtainable
Sima Vaez
What processes are involved for a request to access data/document