Summary: Goal: Evaluation of changes in expression of some inflammatory factors and progesterone receptors in endometrium of women with endometriosis after administration of resveratrol. We hypothesized that resveratrol have anti-inflammatory effects and could alter the expression profile of some inflammatory factors in eutopic endometrium of women with endometriosis. If resveratrol can suppress the expression level of some inflammatory cytokines, possibly will be capable to down-regulate the expression level of some matrix metalloproteinases as well as vascular endothelial growth factor and modify the expression pattern of progesterone receptors. Methods: This study is a triple blind intervention procedure, and designed on 18 to 37 year old females who suffers from endometriosis and not receiving any hormones or supplements during the last three months. 28 women with endometriosis will be included in the study as intervention and control groups and will undergo to endometrial biopsy in the mid-luteal phase. Half of them, as intervention group, will receive 1000 mg resveratrol daily for 12 weeks along with routine treatment of endometriosis and the other half will receive placebo along with the routine treatment of endometriosis. All of them will undergo to biopsy of endometrium in the mid-luteal phase before and after treatment. The rate of expression of some genes and proteins related to inflammatory factors and progesterone receptors will evaluate by RT-PCR and Western blot.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101724569N1
Registration date:2016-05-31, 1395/03/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-31, 1395/03/11
Registrant information
Name
Mahshad Khodarahmian
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 7096
Email address
m-khodarahmian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Resveratrol on expression of inflammatory factors and progestrone receptors in endometrium of women with endometriosis
Public title
The Effects of Resveratrol on Endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No usage of hormonal drugs; hormonal contraceptives; IUDs and supplements during the last three months before the first biopsy; no contraindication of resveratrol such as allergy to grape and green tea; no current suffering from autoimmune or known intestinal diseases; no history of pregnancy or lactation during the last 3 months;Age 18-37 years old; Body mass index between 18.5 to 30 kilograms per square meter.
Age
From 18 years old to 37 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.TUMS.REC.1394.838
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Experission of VEGF gene
Timepoint
Before and after intervention
Method of measurement
RT-PCR
2
Description
Experission of MMP9 gene
Timepoint
Before and after intervention
Method of measurement
RT-PCR
3
Description
Experission of MMP2 gene
Timepoint
Before and after intervention
Method of measurement
RT-PCR
4
Description
Experission of the PRb gene and protein
Timepoint
Before and after intervention
Method of measurement
Western Blot and RT-PCR
5
Description
Experission of the PRA gene and protein
Timepoint
Before and after intervention
Method of measurement
Western Blot and RT-PCR
6
Description
Experission of IL1b gene and protein
Timepoint
Before and after intervention
Method of measurement
Western Blot and RT-PCR
7
Description
Experission of IL8 gene
Timepoint
Before and after intervention
Method of measurement
RT-PCR
8
Description
Experission the gene and TNF alpha protein
Timepoint
Before and after intervention
Method of measurement
Western Blot and RT-PCR
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Consist of the endometrium of infertile women with Endometriosis. They will take routine treatment and placebo (12 week)
Category
Placebo
2
Description
Intervention group: Consist of the endometrium of infertile women with Endometriosis. They will take routine treatment and resveratrol capsule 1000 mg/ daily for 12 week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Mahshad Khodarahmian
Street address
V, Baghdarnia st., after Shahid Bagheri st., Resalat st.,Tehran. Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr. Masud Yunesian
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshad Khodarahmian
Position
PhD student of reproductive biology
Other areas of specialty/work
Street address
Anatomy & Reproductive Biology Department,Tehran University of Medical Sciences, Poursina st., Keshavarz blvd.
City
Tehran
Postal code
1417653791
Phone
+98 21 6641 9072
Fax
Email
m-khodarahmian@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Aligoli Sobhani
Position
PhD
Other areas of specialty/work
Street address
Anatomy & Reproductive Biology Department,Tehran University of Medical Sciences, Poursina st., Keshavarz blvd.
City
Tehran
Postal code
1417653791
Phone
+98 21 6641 9072
Fax
Email
sobhania@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshad khodarahmian
Position
PhD Student of Reproductive Biology
Other areas of specialty/work
Street address
Anatomy & Reproductive Biology Department,Tehran University of Medical Sciences, Poursina st., Keshavarz blvd.
City
Tehran
Postal code
1417653791
Phone
+98 21 6641 9072
Fax
Email
m-khodarahmian@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)