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Evaluation of the effect of hydrodissection with and without vasopressin on antimullerian hormone (AMH) in comparison with the usual method in laparoscopic endometrioma surgery: a double-blind clinical trial

Protocol summary

Study aim
Evaluation of the effect of hydrodissection with and without vasopressin on AMH (Anti-Müllerian hormone) in comparison with the usual method in laparoscopic endometrioma surgery: a double-blind clinical trial
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on all patients. Excel software rand function was used for randomization.
Settings and conduct
The study is double-blind. Will be performed at the Endometriosis Research Center Hazrat Rasool Akram Hospital of Iran University of Medical Sciences.In group one, laparoscopic cystectomy will be performed in a simple and usual way, in group two, cystectomy will be performed by hydrodissection method and in group 3, hydrodissection method will be performed with vasopressin.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Women are 18 to 35 years old at the reproductive age. With endometrioma ovarian cysts less than 10 cm. - Has unilateral ovarian cysts with a diameter of 4 to 10 cm that are confirmed by ultrasound Have a body mass index between 19 and 30. Have not received hormonal drugs, especially GnRH agonists, in the last 3 months. Exclusion criteria Patient with ovarian cancer Breastfeeding period
Intervention groups
In group one, laparoscopic cystectomy will be performed in a simple and usual way, in group two, cystectomy will be performed by hydrodissection method and in group 3, hydrodissection method will be performed with vasopressin.
Main outcome variables
Hemoglobin (Hb) levels the day after surgery and serum Anti-Müllerian hormone (AMH) levels 3 months after surgery will be measured and compared in all three groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150817023666N13
Registration date: 2021-04-20, 1400/01/31
Registration timing: registered_while_recruiting

Last update: 2021-04-20, 1400/01/31
Update count: 0
Registration date
2021-04-20, 1400/01/31
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of hydrodissection with and without vasopressin on antimullerian hormone (AMH) in comparison with the usual method in laparoscopic endometrioma surgery: a double-blind clinical trial
Public title
The effect of hydrodissection on antimullerian hormone (AMH) in laparoscopic endometrioma surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of childbearing age are 18 to 35 years old. With endometrioma ovarian cysts less than 10 cm. Has unilateral ovarian cysts with a diameter of 4 to 10 cm that are confirmed by ultrasound. Have a body mass index between 19 and 30. Have not received hormonal drugs, especially GnRH agonists, in the last 3 months.
Exclusion criteria:
Patients have unilateral ovarian cysts 4 -10 cm in diameter, which are confirmed by ultrasound sonography.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in this study is limited to intervention and control groups using randomization. Random allocation law is the simplest and most limited method of randomization. This method represents a large block for the total sample size. For this purpose, the researchers first determine the total sample size and then randomly divide a set of them into groups A, B, C. For example, in this study with a sample size of 15 balls, 5 balls for intervention group A and 5 balls for intervention group B, and 5 balls for the control group (C) are placed inside a lottery bowl and then the balls are randomly removed from the container and removed. This method is used for two- or multi-group experiments.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and data analyst will not know how the groups are assigned. But because patients' consent must be obtained, the patient knows in which group. For this purpose, before random allocation, a complete explanation of the interventions is given and the patient is told that they will be randomly placed in one of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University Of Medical Sciences
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-10-21, 1399/07/30
Ethics committee reference number
IR.IUMS.REC.1399.684

Health conditions studied

1

Description of health condition studied
Women with endometrioma ovarian cysts
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Antimullerian Hormone changes in patients
Timepoint
Mean levels of Antimullerian Hormone in all patients before and after laparoscopic cystectomy
Method of measurement
Questionnaire and patient file

2

Description
Hemoglobin changes in patients
Timepoint
Mean levels of hemoglobin in all patients before and after laparoscopic cystectomy
Method of measurement
Questionnaire and patient file

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Laparoscopic cystectomy for ovarian cyst surgery is performed by hydro dissection (50-70 ml of normal saline) in which hydrodissection is injected in several points of the cyst wall. Then the cyst wall is removed and for pathology The cyst bed is then checked for bleeding and, if necessary, an electrocautery is used for homeostasis.
Category
Treatment - Drugs

2

Description
Intervention group 2: Laparoscopic cystectomy for ovarian cyst surgery by hydro dissection; Hydrodissection method with vasopressin (Durvana company) in the intervention group, before starting to remove the wall of the cyst 3 ml, contains 0.3 units of an ampoule called vasopressin (Hypress) which contains 20 units and is diluted 200 times in 200 ml of normal saline solution It is inserted into the space between the walls of the ovarian cyst using a special needle, injected at one point of the cyst near the large vessels, followed by 50-70 ml of normal saline is injected at several points. The cyst wall is then removed and sent for pathology. The cyst bed is then checked for bleeding and, if necessary, an electrocautery is used for homeostasis.
Category
Treatment - Drugs

3

Description
Control group: Laparoscopic cystectomy for ovarian cyst surgery is performed in a simple and common way. It is a surgical procedure in which a light vision device (laparoscope) is inserted into the lower abdomen through a small incision, usually made under the umbilicus.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Dr Abolfazl Mehdizadeh Kashi
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9283
Email
mehdizadeh.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abbas Motevalian-Vice President for Research of Iran University of Medical Sciences
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9283
Email
mehdizadeh.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Abolfazl Mehdizadeh Kashi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9283
Email
mehdizadeh.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh kashi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazrate Rasool Akram(s) Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 216651500
Fax
+98 21 6650 9283
Email
mehdizadeh.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh kashi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazrate Rasool Akram(s) Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 216651500
Fax
+98 21 6650 9283
Email
mehdizadeh.a@iums.ac.ir
Web page address
https://scholar.google.com/citations?user=wAk1WUwAAAAJ&hl=en

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of data like the main outcome or the same will be shared
When the data will become available and for how long
Access after 6 months after publication
To whom data/document is available
Data will be available for all researchers
Under which criteria data/document could be used
It can be used for further research and improvement of surgery. Surgeons and gynecologists can use this data.
From where data/document is obtainable
For receiving data please be contacted with mehdizadeh.a@iums.ac.ir
What processes are involved for a request to access data/document
limitless
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