propose: To estimate ovarian reserve after uterine artery embolization and hysterectomy in uterine fibroma treatment.
study design:RCT
Inclusion criteria: age 25-45, sever vaginal bleeding , and pressure effect on pelvic organs.
exclusion criteria: pelvic malignancy,substance media sensitivity.
sample size: 66 cases
Population: women who refer to hospital clinic.
Intervention: determinant FSH levels befor and after uterine artery embolization and hysterectomy
Primery outcome: The same serum FSH levels before and after embolization
Time:20/2/2012 to 20/2/2014
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202163461N5
Registration date:2012-05-05, 1391/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-05, 1391/02/16
Registrant information
Name
Firoozeh Veisi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 4276
Email address
f_veisi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of ovarian reserve after uterine artery embolization and hysterectomy for uterine fibroma
Public title
The evaluation of ovarian reserve after uterine artery embolization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 25-45, sever vaginal bleeding , 16 week mass, anemia and pressure effect caused by uterine fibroma.
exclusion criteria: pelvic malignancy, ovarian patology,pelvic infection,substance media sensitivity.
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
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
Kermanshah University of Medial Sciences
Street address
Kermanshah, Daneshgah Blv,Parastar Av
City
Kermanshah
Postal code
Approval date
2012-02-28, 1390/12/09
Ethics committee reference number
7/420/62088/پ
Health conditions studied
1
Description of health condition studied
uerine fibroma and bleeding
ICD-10 code
N85.8
ICD-10 code description
فیبرومهای اکتسابی رحم
Primary outcomes
1
Description
FSH level
Timepoint
Third day of month before and third day six month after both procedures
Method of measurement
serum level , mIU/ cc
Secondary outcomes
1
Description
Number of dominant follicle between 12-14 days of cycle
Timepoint
Before and 6 month after intervention
Method of measurement
One dominant follicle by sonography
2
Description
Hb level
Timepoint
Before and 6 month after intervention
Method of measurement
Blood level
3
Description
Duration of hospitalization
Timepoint
hospitalization time
Method of measurement
The number of days hospitalization through intervention
4
Description
Time required to return normal activity
Timepoint
The number of weeks to return normal activity
Method of measurement
weeks
5
Description
Pain level after intervention
Timepoint
one week after intervention
Method of measurement
1-10 score
6
Description
Cost of procedure
Timepoint
cost of hospitalization and
Method of measurement
Rials
7
Description
Repeat intervention
Timepoint
By 6 month after first intervention
Method of measurement
Operation and hormonal drugs
8
Description
Patients symptoms
Timepoint
6 month after intervention
Method of measurement
Hot flash, bleeding,pain,..
Intervention groups
1
Description
Embolization:
Record of patient demographic data .
The evaluation of FSH level in third day of cycle before intervention.
The evaluation of Hb level before intervention.
The evaluation of ُّFSH and Hb 6 months after intervention.
The evaluation of ovarian follicle before and 6 months after intervention.
Category
Treatment - Surgery
2
Description
Hysterectomy:
Record of patient demographic data .
The evaluation of FSH level in third day of cycle before intervention.
The evaluation of Hb level before intervention.
The evaluation of ُّFSH and Hb 6 months after intervention.
The evaluation of ovarian follicle before and 6 months after intervention.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
firoozeh veisi
Street address
Kermanshah, Daneshgah blv,Parastar av.
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
firoozeh veisi
Street address
Kermanshah,Daneshgah Blvd.Parastar AV.Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences,Kermanshah,Iran
Full name of responsible person
firoozeh veisi
Position
Assistant professor,faculty member
Other areas of specialty/work
Street address
Kermanshah ,Daneshgah blv,Parastar av.Kermanshah University of Medical Sciences
City
kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
firoozehveisi@yaho.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences,Kermanshah,Iran
Full name of responsible person
firoozeh veisi
Position
Assistant professor ,faculty member
Other areas of specialty/work
Street address
Kermanshah,Daneshgah Blv,Parastar Av.Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
firoozehveisi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences,kermanshah,Iran
Full name of responsible person
firoozeh veisi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 83 1427 6309
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)