Investigating the effect of resveratrol administration on the expression of factors involved in mitochondrial function and biogenesis in granulosa cells of patients with PCOS who are candidates for ART: a three-blind randomized controlled clinical trial
Improving the symptoms of PCOS and the results of ART with the help of resveratrol and using this supplement to manage the treatment of patients
Design
Forty patients with polycystic ovary syndrome are included in the project. Patients are randomly divided into two groups: the group receives eight hundred milligrams of resveratrol per day, and the group receives two placebo capsules for sixty days.
Settings and conduct
Sampling of Omid infertility clinic and Shariati hospital patients
Performing experiments in the embryology laboratory of Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients with infertility caused by PCOS in the age range of 18-40 years. The diagnosis of PCOS will be based on the Rotterdam criteria and having at least two of the following three criteria: amenorrhea or oligomenorrhea, clinical/or biochemical signs of hyperandrogenism, polycystic ovary observation on ultrasound. (Ultrasound criterion for polycystic ovaries is the presence of at least 12 follicles with a diameter of 2 to 9 mm or an increase in ovarian volume of more than 10 cubic centimeters in the transvaginal ultrasound scan).
Exclusion criteria: include pregnancy, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes, or impaired glucose tolerance. Also, people who have used antioxidant supplements, ovulation-inducing drugs, or drugs affecting the hormonal profile 6 months before the start of the plan will not be included in the plan.
Intervention groups
Resveratrol drug user group
Placebo consumer group
Main outcome variables
Evaluation of Sirtuin1 protein expression in granulosa cells
Evaluation of PGC1-α, UCP2, Nrf1, TFAM gene expression in granulosa cells
Assessment of mitochondrial membrane potential
Determining the number of mtDNA copies
Evaluation of ART results
General information
Reason for update
Acronym
PCOs
IRCT registration information
IRCT registration number:IRCT20221106056417N1
Registration date:2023-02-09, 1401/11/20
Registration timing:prospective
Last update:2023-02-09, 1401/11/20
Update count:3
Registration date
2023-02-09, 1401/11/20
Registrant information
Name
Negar Ajabi Ardehjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6842
Email address
n-ajabia@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of resveratrol administration on the expression of factors involved in mitochondrial function and biogenesis in granulosa cells of patients with PCOS who are candidates for ART: a three-blind randomized controlled clinical trial
Public title
Investigating the effect of resveratrol on polycystic ovary syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Polycystic ovary syndrome (PCOS) based on Rotterdam criteria
Polycystic ovary syndrome (PCOS) patients who are candidates for ART
Eligible patients after visiting the women's clinic respectively
will be included in the study randomly. Block randomization
It will be in such a way that within each floor, the method of blocks
is used interchangeably. Blocks are binary and include AB and BA
will be. The randomization tool will be a table of random numbers that will be used For the numbers 0 to 4 in the table of random numbers from the sequences A and B and for Numbers 5 to 9 are used from the sequence of B.A. It is necessary to mention the letter A
It means the intervention group and the letter B means the control group. Direction Concealment We use random allocation concealment to
The way that the assigned group is not known before assigning the individual. the door In this method, each random sequence is created on a card
It will be registered and the cards will be placed in sealed envelopes in order
They are placed. To preserve the random sequence, on
The outer surface of the envelopes is numbered in the same order.
Finally, the lid of the letter envelopes is glued and placed inside box respectively A is placed. At the time of starting the registration of participants, based on The order of entry of qualified participants into the study, one of the envelopes The letter is opened, and the assigned group of that participant is revealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be triple-blind and the patient, the researcher, and the statistical analyst
Patients do not have any information about the type of group therapy and the person who deciphers the code
It is outside the research team. The studied drug is resveratrol and placebo
In a completely similar shape and appearance, each with 60 pieces in a package
There are similar ones in the place of medicine based on random allocation to people
The study will be presented. It should be noted that the medicinal content of each
Which of the bottles was coded by a person outside the research package
The bottles are labeled and the research team is aware of their interpretation
do not have
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dr. Shariati Hospital's educational, research and treatment center
Street address
Dr. Shariati Hospital Educational Research and Treatment Center, Serah Jalal Al Ahmad Street, Karger Shamali St., Tehran
City
tehran
Province
Tehran
Postal code
1411713135
Approval date
2023-01-07, 1401/10/17
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1401.021
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovary syndrome
Primary outcomes
1
Description
Investigating the function and biosynthesis of mitochondria
Timepoint
Sixty days after taking the medicine
Method of measurement
real time PCR, western blot
2
Description
Examining pgc1 gene expression
Timepoint
Sixty days after taking the medicine
Method of measurement
real time PCR
3
Description
Examining NRF1 gene expression
Timepoint
Sixty days after taking the medicine
Method of measurement
real time PCR
4
Description
Examining TFAM gene expression
Timepoint
Sixty days after taking the medicine
Method of measurement
real time PCR
5
Description
Examining UCP2 gene expression
Timepoint
Sixty days after taking the medicine
Method of measurement
real time PCR
6
Description
Analysis of SIRT1 protein expression
Timepoint
Sixty days after taking the medicine
Method of measurement
Western Blot
7
Description
Investigation of mitochondrial membrane potential
Timepoint
Sixty days after taking the medicine
Method of measurement
JC1 staining
8
Description
Analysis mtDNA
Timepoint
Sixty days after taking the medicine
Method of measurement
PCR
Secondary outcomes
1
Description
The number and quality of oocytes
Timepoint
60 days after the start of the intervention
Method of measurement
Counting, optical microscopy
2
Description
Number and quality of embryos
Timepoint
60 days after the start of the intervention
Method of measurement
Counting, optical microscopy
Intervention groups
1
Description
Intervention group: use of resveratrol. In this group of patients, for 60 days until puncture, they take two capsules of 800 mg of resveratrol daily, twice in the morning and in the evening. Their routine treatment, including metformin, is not stopped.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Clinic
Full name of responsible person
Marzieh Agha Hosseini
Street address
Shemiran Gate, Fakhrabad, Shahid Meshki St., next to the Romanian Embassy, Omid Clinic
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7767 0696
Fax
+98 21 7767 0696
Email
info@omidfertility.com
Web page address
https://omidfertility.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Research and Technology Vice-Chancellor, 7th floor, Central Organization of Tehran University of Medical Sciences, corner of Qods St., Keshavarz Blvd, Tehran.
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Tayebe Rastgar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Porsina St. - Faculty of Medicine
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Email
trastegar@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Tayebe Rastegar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Porsina St. Faculty of Medicine, Tehran University of Medical Sciences.
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Email
trastegar@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negar Ajabi Ardeh jani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Building No. 4, Porsina St., Ghods St., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6405 3404
Email
n-ajabia@razi.tums.ac.ir
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
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
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
All the data obtained in the research will be published in one of the relevant scientific journals.
When the data will become available and for how long
Beginning of access spring 1403
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data of this research can be used as an adjuvant treatment method in patients with polycystic ovary syndrome undergoing IVF/ICSI.
From where data/document is obtainable
Negar Ajabi Ardeh jani
What processes are involved for a request to access data/document