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Comparison of suppressive hormonal therapy(LD tablet) with aspiration in regression of ovarian endometrioma

Protocol summary

Summary
The aim of this study is comparison of hormone suppressor (LD pill) with aspiration in regression of ovarian endometrioma. In this study womens aged 15-45 who have reffered to Al-Zahra Hospital with ultrasonographic criteria that who have had unilateral endometrioma with size less than or equal to 6 centimeters and test CA 100> 125, randomly placed in one of the following groups. The possibility of malignancy will be excluded. A) Hormone Suppressor Group: after taking informed consent, patinets daily received one LD pill for three months and at the end, the ultrasound is performed again in terms of cyst regression. Up to 3 months after treatment and cyst regression, the patients will be followed. Questionnaire at the time of inclusion, one, three and six months after treatment, the improvement of clinical symptoms (including: dysmenorrhea, dyspareunia and pelvic pain),regression or recurrence of cyst will be filled. B) Aspiration Group: after taking informed consent, cyst aspiration under the ultrasound is done by one of the associates of infertility. Three and six months after aspiration, ultrasound is performed again in terms of the re-formation of cysts. Questionnaire at the time of inclusion, one, three and six months after aspiration, in terms of clinical improvement and cyst recurrence and need to re-aspiration will be filled. After determining inclusion criteria, division of patientswill be done with block randomization and the corresponding software. The study is not blinded. primary outcome: cyst regression, improvement of clinical symptoms, including: dysmenorrhea, dyspareunia and pelvic pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201609105563N8
Registration date: 2016-10-02, 1395/07/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-02, 1395/07/11
Registrant information
Name
Elaheh Ouladsahebmadarek
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
madarek@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2019-08-01, 1398/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of suppressive hormonal therapy(LD tablet) with aspiration in regression of ovarian endometrioma
Public title
Comparison of suppressive hormonal therapy(LD tablet) with aspiration in regression of ovarian endometrioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: womens aged 15-45; unilateral endometrioma, endometrioma diagnosis with ultrasound; CA 125<100; mass size less than or equal to 6 cm Exclusion criteria: the possibility of malignancy; contraindications of LD pill; ischemic heart disease or previous history of it; current breast cancer; liver tumors (benign and malignant))
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
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
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2016-09-06, 1395/06/16
Ethics committee reference number
IR.TBZMED.REC.1395.572

Health conditions studied

1

Description of health condition studied
Endometriosis of ovary
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary

Primary outcomes

1

Description
size of the cyst
Timepoint
One, three and six months after treatment
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Dysmenorrhea
Timepoint
One, three and six months after treatment
Method of measurement
Questionnaire

2

Description
Dyspareunia
Timepoint
One, three and six months after treatment
Method of measurement
Questionnaire

3

Description
Pelvic pain
Timepoint
One, three and six months after treatment
Method of measurement
(Incontinence quality of life =I-QOL)

Intervention groups

1

Description
In intervention group A: LD tablets daily for three months a number
Category
Treatment - Drugs

2

Description
The intervention group B: Aspiration of the cyst
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Elaheh Ouladsahebmadarek
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.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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