Evaluation and comparison of the sclerotherapy and laparoscopic cystectomy on the ovarian reserve and the disease relapse of patients with ovarian endometriosis in university hospitals, Isfahan
Evaluation and comparison of the sclerotherapy and laparoscopic cystectomy on the ovarian reserve and the disease relapse of patients with ovarian endometriosis
Design
A three phase clinical trial with two intervention groups, in parallel, not-blinded, randomized with simple method, with sample size of 70
Settings and conduct
This study is a randomized not-blinded clinical trial in Isfahan University Hospitals. The study population consists of 70 patients with ovarian endometriosis and chronic pelvic pain. Patients are included in the study if they met the inclusion criteria and after giving written consent and then are randomly divided into two groups.The first group will consist of 35 patients undergoing sclerotherapy under sedation with cook needle and the second group will include 35 patients undergoing laparoscopic cystectomy for endometrial lesions.After intervention in both groups, control ultrasound will be performed about 12 weeks later in case of evaluation the recurrence of the lesions. Ovarian follicle reserve is also measured by anti-mullerian hormone (AMH) assay, which may indicate an effect on fertility.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Detection of endometriosis by ultrasound or MRI
Patient Satisfaction for Inclusion
Ages over 18 years
No doubt to malignancy
Abnormal amounts of CA125 tumor marker
Having infertility
Having chronic pelvic pain
Ovarian cysts about 4-8 cm
Exclusion criteria:
Patients whose information is incomplete
Non-endometriotic ovarian masses
History of any malignancy
Intervention groups
The first group will consist of 35 patients undergoing sclerotherapy under sedation with cook needle and the second group will include 35 patients undergoing laparoscopic cystectomy for endometrial lesions.
Main outcome variables
Recurrence of lesions,ovarian reserve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N31
Registration date:2020-03-05, 1398/12/15
Registration timing:registered_while_recruiting
Last update:2020-03-05, 1398/12/15
Update count:0
Registration date
2020-03-05, 1398/12/15
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the sclerotherapy and laparoscopic cystectomy on the ovarian reserve and the disease relapse of patients with ovarian endometriosis in university hospitals, Isfahan
Public title
Comparison of sclerotherapy and laparoscopic cystectomy on ovarian reserve and disease relapse in patients with ovarian endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of endometriosis by ultrasound or MRI
Patient Satisfaction for Inclusion
Ages over 18 years
No doubt to malignancy
Abnormal amounts of CA125 tumor marker
Having infertility
Having chronic pelvic pain
Ovarian cysts about 4-8 cm
Exclusion criteria:
Patients whose information is incomplete
Non-endometriotic ovarian masses
History of any malignancy
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in this study are randomly divided into two groups of A and B. In this way, a code is provided for each of the two intervention groups, and patients are randomly assigned to one of the two groups by choosing one of the two codes.
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 Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
IR.MUI.MED.REC.1398.499
Health conditions studied
1
Description of health condition studied
Ovarian endometriosis
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Recurrence of endometriosis lesions
Timepoint
12 weeks after interventon
Method of measurement
Sonography
2
Description
Ovarian reserve
Timepoint
12 weeks after interventon
Method of measurement
Measurement of anti-mullerian hormoneserum levels
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: The first group will consist of 35 patients undergoing sclerotherapy with cook needle under sedation. The method of treatment for sclerotherapy is that transvaginal sclerotherapy is performed under sedation and sonography guide and if the surgeon observes endometriosis, the specimen is punctured with a special puncture needle and aspirated. Then about 80% of the volume aspirated up to a maximum of 100 ml from ethanol 95% enters the lesion.The ethanol stays in the lesion for about 20 minutes and then is completely discharged to eliminate ethanol complications. Patients will be monitored for at least 3 hours.
Category
Treatment - Surgery
2
Description
Second intervention group: the second group will include 35 patients undergoing laparoscopic cystectomy for endometrial lesions.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Hatav Ghasemi Tehrani
Street address
Soffeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
Hatav.tehrani2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Professor of gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
Hatav.tehrani2014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Professor of gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
Hatav.tehrani2014@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Professor of gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
Hatav.tehrani2014@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available