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Review of Sclerotherapy By Ethanol 95% On The Rate Of Treatment Of Recurrent Ovarian Endometrioma

Protocol summary

Summary
The overall objective: Review of treatmentof endomethrioma and rate of recurrence after procedure Specific goals: Rate of treatment by results of sonography after 1,3,6 and 12 months- Rate of having pain after 1,3,6 and 12 months- Rate of treatment based on lab data (CA125,FSH,AMH,E2,AFC) after 1,3,6 and 12 months-Rate of treatment based on recurrence after1,3,6 and 12months Practical purpose: the effectiveness of sclerotherapy with 95% ethanol in the treatment and prevention of recurrent ovarian endometrioma recurrence of this method can be recommended as a therapy Exclusion criteria: Complete etic form؛ Previous cystectomy but recurrence؛ FSH<10؛ AMH>1؛ Inclusion criteria: FSH>10؛ AMH<1؛ age>38؛ lack of etic form؛ Patients pregnant؛ Patients virgin A 22 patients with recurrence ovarian endomethrioma will be selected and will have been sclreotherapy by transvaginal sonography,and the cyst will be vacated and after washing by normal saline,injecting alchohol 95% to the cyst,then vacating alchohol and will be remined only 5cc.then antibiothic therapywill be done.patients will be followed 1 month, 3 months, 6 months and 12 months after procedure.also lab data will be followed.(CA125,AFC, FSH,AMH,E2) in selected patients,will done procedure(sclerotherapy) and then will follow by trans vaginal sonography and lab data every 3months. we will have no control group The primary outcome variable increases the chances of pregnancy and time in the first month, third month, sixth month of the twelfth month of the measurement., And an ultrasound examination before the measure is

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405286541N5
Registration date: 2014-08-08, 1393/05/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-08-08, 1393/05/17
Registrant information
Name
Bahia Namavar Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
namavarb@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review of Sclerotherapy By Ethanol 95% On The Rate Of Treatment Of Recurrent Ovarian Endometrioma
Public title
Treatment of Ovarian Endomethrioma
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: Complete etic form؛ Previous cystectomy but recurrence؛ FSH<10؛ AMH>1؛ Inclusion criteria: FSH>10؛ AMH<1؛ age>38؛ lack of etic form؛ Patients pregnant؛ Patients virgin
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Science Researching، Shiraz Univercity of Medical Science
Street address
Shiraz University Of Medical Sciences
City
Shiraz
Postal code
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
CT-P-91-4360

Health conditions studied

1

Description of health condition studied
- Treatment of ovarian endomethrioma
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
Increasing of pregnancy
Timepoint
1,3 ,6 and 12 months
Method of measurement
By songraphy and lab data

Secondary outcomes

1

Description
Decreasing of abdominal pain
Timepoint
1,3,6 and 12 months
Method of measurement
By pain score table

Intervention groups

1

Description
in selected patients,will done procedure(sclerotherapy) and then will follow by trans vaginal sonography and lab data every 3months. we will have no control group .
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother & Child Hospital،Shiraz
Full name of responsible person
Dr Morvarid Ahmad Beygi
Street address
Mother & Child hospital ، Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Dr Morvarid Ahmad Beygi
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University Of Medical Science
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Morvarid Ahmad Beygi
Position
Resident Of GYN
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences ، Zand Street
City
Shiraz
Postal code
Phone
+98 71 1227 9715
Fax
Email
morvarid_ab@yahoo.com s.kharati@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Bahia Namavar Jahromi
Position
Professor of Obstetrics & GYN, Fellowship Infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
Phone
+98 71 1227 9715
Fax
Email
namavarb@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Morvarid Ahmad Beygi
Position
Resident of GYN
Other areas of specialty/work
Street address
Zand Street ،Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1227 9715
Fax
Email
morvarid_ab@yahoo.com s.kharati@yahoo.com
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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