Evaluation of changes in sera levels of interleukin 1 β (IL-1β), IL-6, IL-8, and anti-mullerian hormone (AMH) following ethanol sclerotherapy in patients with endometrioma using reterntion method
Evaluation of changes in sera levels of interleukin 1 β (IL-1β), IL-6, IL-8, and anti-mullerian hormone (AMH) following ethanol sclerotherapy in patients with endometrioma using reterntion method
Design
This study is a clinical trial with 25 patients with endometriosis without control group and one-way blind.
Settings and conduct
This study will be performed on 25 patients with endometriosis who have been referred to Al-Zahra Hospital in Tabriz.In this study, only the data analyzer will be blind.The type of sampling method will be non-random.Before any intervention, the sera levels of interleukin (IL) 1 β, IL-6, IL-8, and antimullerian hormone would be evaluated. Then, using transvaginal ultrasound evaluation the cyst will be detected and the filling fluid aspirated and washed until it became clear. After that, about 75% of the apirated volume would be injected into the cyst and the patient will be discharged after recommendations.
Participants/Inclusion and exclusion criteria
In this study, patients with endometriosis will be included in the study and in case of inflammatory and autoimmune diseases as well as patients with cysts with a volume of more than 150 ml will be barred from entering the study.
Intervention groups
Using transvaginal ultrasound evaluation the cyst will be detected and the filling fluid aspirated and washed until it became clear. After that, about 75% of the apirated volume would be injected into the cyst and the patient will be discharged after recommendations.
Main outcome variables
IL-1β level assessment; IL-6; IL-8; AMH and cyst recurrence are the consequences of this study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130115012146N9
Registration date:2021-11-06, 1400/08/15
Registration timing:registered_while_recruiting
Last update:2021-11-06, 1400/08/15
Update count:0
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Laaya Farzadi
Name of organization / entity
Woman's Reproductive Health Research Center of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
farzadl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-03, 1400/08/12
Expected recruitment end date
2022-11-03, 1401/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of changes in sera levels of interleukin 1 β (IL-1β), IL-6, IL-8, and anti-mullerian hormone (AMH) following ethanol sclerotherapy in patients with endometrioma using reterntion method
Public title
Evaluation of serum changes in inflammatory agents in patients with endometrioma after ethanol injection by residual method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with symptomatic endometrial cysts above 3 cm
Women with asymptomatic endometrial cysts above 3 cm
Willingness to cooperate
Exclusion criteria:
Patients with a history of malignancy
Patients with a history of inflammatory and autoimmune diseases
Patients with a history of corticosteroid and immunosuppressive drugs
Patients with a history of taking non-steroidal anti-inflammatory drugs for the past 7 days
Patients with abnormal CEA-125 levels
Patients with cysts with a volume of more than 150 ml
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
supervisor ،who is not involved in the collection and analysis of study data and the researcher will be aware of the study groups and the data analyst will be blinded
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.TBZMED.REC.1400.598
Health conditions studied
1
Description of health condition studied
Endometriosis of ovary
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Evaluation of serum interleukin (IL) levels 1β
Timepoint
Before the intervention and three months after the end of the intervention
Method of measurement
Blood test
2
Description
Evaluation of serum IL-6 levels
Timepoint
Before the intervention and three months after the end of the intervention
Method of measurement
Blood test
3
Description
Evaluation of serum IL-8 levels
Timepoint
Before the intervention and three months after the end of the intervention
Method of measurement
Blood test
4
Description
Evaluation of serum AMH levels
Timepoint
Before the intervention and three months after the end of the intervention
Method of measurement
Blood test
Secondary outcomes
1
Description
Recurrence of the cyst
Timepoint
Before the intervention and three months after the end of the intervention
Method of measurement
Vaginal ultrasound
Intervention groups
1
Description
Before any intervention, the sera levels of interleukin (IL) 1 β, IL-6, IL-8, and antimullerian hormone would be evaluated. Then, using trans vaginal ultrasound evaluation the cyst will be detected and the filling fluid aspirated and washed until it became clear. After that, about 75% of the apirated volume would be injected into the cyst and the patient will be discharged after recommendations. up:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Farzadi Laya
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Samiei
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farzadi Laaya
Position
Fellowship of Infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farzadi Laaya
Position
Fellowship of Infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farzadi Laaya
Position
Fellowship of Infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
0098 35519161
Email
lahroudin@gmail.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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