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The use of oral contraceptive in treatment of endometrial polyps sized less than 1.5 cm in women aged 20-40 years

Protocol summary

Summary
This study outlines the efficacy of oral contraceptive in the treatment of endometrial polyps (EPs) sized less than 1.5 cm. Design: a randomized controlled clinical trial. Patients: 50 women, who are of childbearing age and have asymptomatic EPs smaller than 1.5 cm. Women will be assigned to two groups consist of 25 persons in each. Inclusion criteria will be: all women who are of childbearing age, have asymptomatic EPs smaller than 1.5 cm, aged 20 to 40 years, and the EPs randomly determined by vaginal ultrasound methods. Exclusion criteria will be: patients with history of oral contraceptive intake, infertility, pelvic pain, liver disease, thrombo-embolism, diabetes, hypertension, uterine fibroma and adenomyosis, infertility due to non-uterine causes, ... Intervention: Oral contraceptives periodically for 3 months. Main outcome measures: vaginal ultrasonography and measuring EPs size at beginning of the study and after 3 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102275920N1
Registration date: 2011-05-07, 1390/02/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-07, 1390/02/17
Registrant information
Name
Sulmaz Natanj
Name of organization / entity
Jundishapour university of medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 2344
Email address
natanj.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundshapour University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The use of oral contraceptive in treatment of endometrial polyps sized less than 1.5 cm in women aged 20-40 years
Public title
The use of oral contraceptive in treatment of endometrial polyps sized less than 1.5 cm in women aged 20-40 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: reproductive age, asmptomatic endometrial polyps smaller than 1.5 cm, aged 20-40 years. Exclusion criteria: malignancy, contraindication of OCP, utrine myoma, symptomatic polyp
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jundishapour University of Medical Scienses
Street address
Golestan Blvrd
City
Ahvaz
Postal code
Approval date
2010-06-07, 1389/03/17
Ethics committee reference number
ETh014

Health conditions studied

1

Description of health condition studied
endometrial polyp
ICD-10 code
N84.0
ICD-10 code description
Polyp of corpus uteri

Primary outcomes

1

Description
size of polyp
Timepoint
before intervention and after 3 months
Method of measurement
trans vaginal sonogeraphy

Secondary outcomes

empty

Intervention groups

1

Description
intervention: ocp tab, once daily for 3 months
Category
Treatment - Drugs

2

Description
control group: without intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Emam Khomeini hospital
Full name of responsible person
Maryam Baghaeenejhad
Street address
Ahvaz Emam Khomeini hospital
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jundishapour University Of Medical Scienses
Full name of responsible person
Dr. Mostafa Feghhi, Vice-Chancellor For Research
Street address
Vice-Chancellor For Research, Ahvaz University of Medical Scienses
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapour University Of Medical Scienses
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
Jundishapour University of Medical Scienses
Full name of responsible person
Dr. Mojhgan Barati
Position
Assistant Professor of Obstetrics & Gynecology
Other areas of specialty/work
Street address
Ahvaz Emam Khomeini hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 2922
Fax
Email
brati_m@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jundishapour university of medical scienses
Full name of responsible person
Dr. Mojhgan Barati
Position
Assistant Professor Of Obstetrics & Gynecology
Other areas of specialty/work
Street address
Ahvaz Emam Khomeini hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 2022
Fax
Email
brati_m@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jundishapour University Of Medical Scienses
Full name of responsible person
Maryam Baghaeenejhad
Position
Resident of Obstetrics & Gyenecology
Other areas of specialty/work
Street address
Ahvaz Emam Khomeini hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 2922
Fax
Email
baghain.m@ajums.ac.ir
Web page address

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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