1. Home
  2. Approved trials
  3. » فارسی

Evaluating the effect of uterine artery embolization on fertility

Protocol summary

Study aim
Determine the fertility rate following the uterine artery embolization
Design
In this clinical trial study, 60 patients with uterine fibroid will be separated into two groups. interventional group will be treated with uterine artery embolization and control group will be treated with myomectomy.
Settings and conduct
this prospective study will be done in the Radiology ward at Firoozgar hospital in partnership with the maternity ward. All patients with the diagnosis of fibroid that will be treated with uterine artery embolization will be included. patients answer the questionnaire for uterine fibroid sign and symptoms. after the intervention, CBC, CRP, Duration of returning to work, Early complications, infections, PTE and hysterectomy will be checked. All patients will be followed 6 months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: smaller than 40 years old, Intending to get pregnant sonography explain myoma in uterine larger than 4cm in the largest diameter, the serum level of FSH lower than 30 IU/L in the third day of period. Exclusion criteria: peduncular fibroid with thin pedicle, fibroid bigger than uterine in 24 weeks of pregnancy, intracavity part of fibroid larger than 3cm, virgin patient want to get married.
Intervention groups
In this study interventional group will be treated with uterine artery embolization. Control group will be treated with myomectomy.
Main outcome variables
LH, FSH and Estradiol(third day of period), the sign of uterine fibroid questionnaire, CBC, CRP and CA-125(tumor marker), Duration of returning to work.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170925036388N2
Registration date: 2018-02-23, 1396/12/04
Registration timing: registered_while_recruiting

Last update: 2018-02-23, 1396/12/04
Update count: 0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6606 9049
Email address
rajabzadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of uterine artery embolization on fertility
Public title
Evaluating the effect of uterine artery embolization on fertility
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Smaller than 40 years old Intending to get pregnant Sonography explain myoma in uterine larger than 4cm in the largest diameter (biggest one larger than 4cm, for more than one myoma) Serum level of FSH lower than 30 IU/L in third day of period
Exclusion criteria:
Peduncular fibroid with thin pedicle that is smaller than 50% of fibroid apex. Fibroid bigger than uterine in 24 weeks of pregnancy Intracavity part of fibroid larger than 3cm Virgin patient want to get married (except patient with previous surgery)
Age
To 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.IUMS.FMB.IEC1396.9411282010

Health conditions studied

1

Description of health condition studied
uterine fibroid
ICD-10 code
D25.9
ICD-10 code description
Leiomyoma of uterus, unspecified

Primary outcomes

1

Description
LH, FSH and Estradiol(third day of period)
Timepoint
Baseline and 6 months after surgery
Method of measurement
Blood sampling

2

Description
Sign of uterine fibroid questionnaire
Timepoint
Baseline and 6 months after surgery
Method of measurement
Questionnaire

3

Description
CBC
Timepoint
Baseline and 6 months after surgery
Method of measurement
Blood sampling

4

Description
Duration of returning to work
Timepoint
6 months after surgery
Method of measurement
Asking the patient

5

Description
CRP
Timepoint
Baseline and 6 months after surgery
Method of measurement
Blood sampling

6

Description
CA-125(tumor marker)
Timepoint
Baseline and 6 months after surgery
Method of measurement
Blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will be treated with uterine artery embolization. Then LH, FSH, Estradiol and CA-125(tumor marker) will be checked 6 months after surgery.
Category
Treatment - Surgery

2

Description
Control group: Patients will be treated with myomectomy.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr. Alale Rajabzade Kanafi
Street address
Firoozgar hospital, Behafarin St., Karim kan Ave., Valiasr Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Babaei
Street address
Interventional sonography room, Firoozgar hospital, Beh Afarin street, Karim Khan Ave., Valiasr Sq.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Mohamad Reza babaei
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Alale Rajabzade Kanafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Interventional sonography room, Firoozgar hospital, Beh Afarin street, Karim Khan Ave., Valiasr Sq.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 6606 9049
Fax
Email
rajabzadeh.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Babaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Interventional sonography room, Firoozgar hospital, Beh Afarin street, Karim Khan Ave., Valiasr Sq.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Alale Rajabzade Kanafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Interventional sonography room, Firoozgar hospital, Beh Afarin street, Karim Khan Ave., Valiasr Sq.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 6606 9049
Fax
+98 21 6606 9049
Email
rajabzadeh.a@iums.ac.ir

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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information used for this research can be shared after unidentifying the identity of patients.
When the data will become available and for how long
Starting access after accepting by a valid scientific journal and publishing it
To whom data/document is available
For academic researchers and in the field of science
Under which criteria data/document could be used
All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned.
From where data/document is obtainable
Dr. Alale Rajabzade Email: rajabzadeh.a@iums.ac.ir
What processes are involved for a request to access data/document
The applicant can request the type of files by email.
Comments
Loading...