The effectof omega 3 fatty acids supplemention on uterine prostaglandineE2 and aromatase P450 in patients with leiomyoma
Design
Take uterine flushing and uterine biopsy from both groups in special days of menstrual cycles. then we are going to give omega 3 for three monthes for first group and again after taking drugs , biopsies of tissue and uterus fluid will be taken .. in first group these topics will be study befor and after rteatmenr: 2.numbers of pathologys in every patient and biggest pathology in every patient .
Settings and conduct
Take uterine flushing and uterine biopsy from both groups in special days of menstrual cycles. then we are going to give omega 3 for three months for first group and again after taking drugs , biopsies of tissue and uterus fluid will be taken .. in first group these topics will be study before and after treatment: 2.numbers of pathology in every patient and biggest pathology in every patient .
Participants/Inclusion and exclusion criteria
People in the age range of 25-40 years and they will enter the study with leiomyoma and patients with uterine obstruction, hormonal disorders, AUB, PCO and metabolic disorders, taking hormonal drugs and uterine polyps
Intervention groups
In this study, patients are divided into two groups. The control group
(Lyomium-free and other diseases includes 10 patients diagnosed with leiomyoma that the beginning of the uterine fluid sample and uterine tissue, a cycle is taken on a specific day And will be treated with routine, but the intervention group (10 people) in addition to receiving routine treatment, They will receive an omega-3 gelatin capsule at a dose of 1,000 mg per day for 3 months After 3 months, both groups will be examined again for the number of leiomyoma lesions and the size of the largest lesion in each patient.
Main outcome variables
Number and size of leiomyomas
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130115012146N7
Registration date:2020-07-05, 1399/04/15
Registration timing:registered_while_recruiting
Last update:2020-07-05, 1399/04/15
Update count:0
Registration date
2020-07-05, 1399/04/15
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
2020-06-21, 1399/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectof omega 3 fatty acids supplemention on uterine prostaglandineE2 and aromatase P450 in patients with leiomyoma
Public title
The effectof omega 3 fatty acids supplemention on uterine prostaglandineE2 and aromatase P450 in patients with leiomyoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 40-25 years
Intra molar myomas are less than 50% prominent in the uterine cavity.
Patients with leiomyoma who have been treated for myomas have not used hormonal drugs, including GNRH agonists, progesterone, and so on.
Exclusion criteria:
Patients with uterine obstruction, AUB, PCO and , taking hormonal drugs and
Patients with hormonal disorders
Patients with Polycystic ovary syndrome
Patients with abnormal uterine bleeding
Patients with metabolic disorders
Patients taking hormonal drugs.
Patients with uterine polyps
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
2020-06-22, 1399/04/02
Ethics committee reference number
IR.TBZMED.REC.1399.312
Health conditions studied
1
Description of health condition studied
Uterine Myoma
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
size of myoma
Timepoint
Three months after taking the drug
Method of measurement
sonography
2
Description
Number of uterine fibroids
Timepoint
Three months after taking the drug
Method of measurement
sonography
Secondary outcomes
1
Description
PGE2 levels in uterine fluid
Timepoint
Three months after taking the drug
Method of measurement
Measurement in the laboratory
2
Description
The amount of aromatase and PGES genes
Timepoint
Three months after taking the drug
Method of measurement
Measurement in the laboratory
Intervention groups
1
Description
Intervention group: we are going to take uterine flushing and uterine biopsy in special days of menstrual cycles . then we are going to give omega 3 for three months for intervention group and again after taking drugs , biopsies of tissue and uterus fluid will be taken
Category
Treatment - Drugs
2
Description
Control group:Take Uterine flushing and uterine biopsy in special days of menstrual cycles
Category
Diagnosis
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
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
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
5138663134
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
فلوشیپ نازایی
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
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3553 9161
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