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The effect of Resveratrol on the expression of the granulosa apoptosis-associated genes in polycystic ovary syndrome and its relationship with in vitro fertilization outcome

Protocol summary

Study aim
The effect of Resveratrol on the expression of some genes involved in the process of apoptosis in granulosa cells in patients with polycystic ovary syndrome and its relationship with the consequences of in vitro fertilization.
Design
Clinical trial with control and intervention group, with parallel groups, triple blind, randomized, phase 3 on 40 patients, random blocking was used for randomization.
Settings and conduct
Patients referred to infertility center of Hormozgan University of Medical Sciences who are included in the study underwent ovulation induction protocol (antagonist protocol). Granulosa cells will be collected and centrifuged on the day of ovulation. The cell pellete will be used to extract RNA. The expression of Survivin, Caspase 3, and Caspase7 genes will be evaluated using Real-time PCR.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with polycystic ovary syndrome based on Rotterdam criteria, Women of childbearing age between 18 and 40 years, Candidate for in vitro fertilization, Not receiving insulin Exclusion criteria: FSH > 10, high grade endometriosis (III and IV), thyroid diseases, congenital adrenal hyperplasia, hyperprolactinemia, ovarian secretion tumors, lupus and autoimmune diseases, the consumption of red grapes, pistachios, peanuts and berries, sensitivity to fruits such as red grapes, pistachios and strawberries, receiving insulin, diabetes mellitus, cushing's syndrome
Intervention groups
Intervention group: Receiving 40 days of resveratrol (800 mg once daily) from the beginning of the menstrual cycle until the day of ovulation Control group: receiving 40 days of placebo
Main outcome variables
Apoptosis, number of eggs, number of embryos, embryo quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200905048630N1
Registration date: 2020-09-21, 1399/06/31
Registration timing: prospective

Last update: 2020-09-21, 1399/06/31
Update count: 0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Ensieh Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 0755
Email address
salehiensieh@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Resveratrol on the expression of the granulosa apoptosis-associated genes in polycystic ovary syndrome and its relationship with in vitro fertilization outcome
Public title
The effect of Resveratrol on the expression of the granulosa apoptosis-associated genes in polycystic ovary syndrome and its relationship with in vitro fertilization outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovary syndrome based on Rotterdam criteria Women of childbearing age between 18 and 40 years Candidate for in vitro fertilization Not receiving insulin
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients (including 40 patients) are randomly assigned by a statistical expert using a simple randomization method. In this method, the Random between function of Excell program is used to generate a random number between 1 and 2. This is repeated 40 times and therefore a random sequence is obtained.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, research assistants, and investigators were masked to treatment allocation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Shahid Mohammadi Hospital, Shafa Alley, Jomhouri Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2020-08-02, 1399/05/12
Ethics committee reference number
IR.HUMS.REC.1399.234

Health conditions studied

1

Description of health condition studied
polycystic ovarian syndrome: PCOS
ICD-10 code
E28.2
ICD-10 code description
polycystic ovarian syndrome

Primary outcomes

1

Description
Apoptosis
Timepoint
40 days after the beginning of the intervention
Method of measurement
real time pcr

Secondary outcomes

1

Description
Egg numbers
Timepoint
40 days after the beginning of the intervention
Method of measurement
Counting

2

Description
Number of embryos
Timepoint
43 days after the beginning of the intervention
Method of measurement
Counting

3

Description
Number of good quality embryo
Timepoint
43 days after the beginning of the intervention
Method of measurement
Counting

Intervention groups

1

Description
Intervention group: from the beginning of the cycle, individuals in this group will receive one 99% pure trans-Resveratrol capsule (800 mg per day) as orally purchased from the US company Mega Resveratrol.
Category
Treatment - Drugs

2

Description
Control group:from the beginning of the cycle, individuals in this group will receive one placebo capsule per day as orally purchased from the US company Mega Resveratrol.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility center of Hormozgan university of medical sciences
Full name of responsible person
Ensieh salehi
Street address
Shahid Mohammadi Hospital, Infertility Center,Shafa Alley, Jomhouri Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
salehiensieh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Teamur Aghamolaei
Street address
Shahid Mohammadi Hospital, Research Deputy, Jomhouri Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Ensieh salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Fertility and Infertility research Center, Shahid Mohammadi Hospital, Shafa Alley, Jomhouri Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
salehiensieh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Ensieh salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Fertility and Infertility Research Center, Shahid Mohammadi Hospital, Shafa Alley, Jomhouri Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
salehiensieh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Ensieh salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Fertility and Infertility Research Center, Shahid Mohammadi Hospital, Shafa Alley, Jomhouri Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
0763330755
Email
salehiensieh@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
Undecided - It is not yet known if there will be 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
All data obtained in the research will be published in one of the valid and related scientific journals.
When the data will become available and for how long
2022
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data of this study can be used as an adjuvant therapy in patients with polycystic ovary syndrome underwent IVF/ICSI.
From where data/document is obtainable
Dr. Ensieh salehi salehiensieh@gmail.com
What processes are involved for a request to access data/document
By sending an email to the corresponding author.
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