Protocol summary

Summary
The purpose of this study is investigating the anti-Mullerian hormone level in two treatment methods, myomectomy and uterine artery embolization, in patients with uterine fibroids. 50 women with fibroid problems referred to Imam Reza Hospital will be selected through available method and divided in two groups by choosing their type of treatment (Uterine artery embolization and myomectomy). Each patient is screened for anti Mullerian hormone level before operation. Patients are categorized in four age groups 20-25 and 25-30 and 30-35 and 35-40 and they are adjusted by age at two treatment methods. Pain on the third day, early occurred complications and the numbers of hospitalization days are recorded before discharge. Then each two weeks after operation, complications such as severe pain, hematoma, fever, infection, urinary problems and bleeding will be evaluated and anti-Mullerian hormone and hemoglobin levels will be checked 6 months after surgery. Inclusion criteria: age 25-40 years; having debilitating complaints such as severe bleeding due to myoma, uterine enlargement up to 16 weeks pregnancy, anemia and pressure on the pelvic organs of patients which candidates her for myomectomy. Exclusion criteria: probability of pelvic malignancies, ovarian pathologies, pelvic infections; desiring fertility, contrast sensitivity, renal disorders, and systemic autoimmune disorders.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020114333N17
Registration date: 2014-02-12, 1392/11/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-12, 1392/11/23
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-09-11, 1392/06/20
Expected recruitment end date
2014-08-11, 1393/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anti-Mullerian hormone level in two treatment methods, myomectomy and uterine artery embolization, in patients with uterine fibroids
Public title
Anti-Mullerian hormone levels of uterine artery embolization in the treatment of patients suffering Myomectomy and uterine leiomyoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 25-40 years; having debilitating complaints such as severe bleeding due to myoma, uterine enlargement up to 16 weeks pregnancy, anemia and pressure on the pelvic organs of patients which candidates her for myomectomy. Exclusion criteria: probability of pelvic malignancies, ovarian pathologies, pelvic infections; desiring fertility, contrast sensitivity, renal disorders, and systemic autoimmune disorders.
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
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 Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-09-11, 1392/06/20
Ethics committee reference number
31564/پ/7/420

Health conditions studied

1

Description of health condition studied
utrine fibroids and bleeding
ICD-10 code
N85.8
ICD-10 code description
Other specified noninflammatory disorders of uterus

Primary outcomes

1

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

2

Description
anti-Mullerian hormone level
Timepoint
Baseline and 6 months after surgery
Method of measurement
Measurement in the laboratory

3

Description
Patients’ complaints (hot flush, bleeding, pelvic pain and pressure, urinary problems, etc.)
Timepoint
6 months after intervention
Method of measurement
Asking the patient

4

Description
Pain level
Timepoint
One week after intervention
Method of measurement
Asking the patient

5

Description
Duration of hospitalization
Timepoint
Discharge date
Method of measurement
Based on patient records

6

Description
Cost of treatment
Timepoint
Discharge date
Method of measurement
Based on patient records

Secondary outcomes

empty

Intervention groups

1

Description
In the second treatment group, patients will be treated through myomectomy. Then anti-Mullerian hormone and hemoglobin levels will be checked 6 months after surgery.
Category
Treatment - Surgery

2

Description
In the first treatment group, patients will be treated through uterine artery embolization. Then anti-Mullerian hormone and hemoglobin levels will be checked 6 months after surgery.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr.Afsaneh Mansouri
Street address
Emam Reza Hospital,Razi Boulevard,Sorkhleje
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.farahnaz Keshavrzi
Position
Special of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Emam Reza Hospital,Razi Boulevard,Sorkhleje
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
fnkeshavarzi@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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