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Comparison of ovarian reserve in laparoscopic endometrioma surgery with and without vasopressin injection

Protocol summary

Study aim
Determination and comparison of ovarian reserve in laparoscopic endometrioma surgery with and without vasopressin injection
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 44 patients
Settings and conduct
In this randomized double-blind randomized clinical trial study, 44 women of reproductive age with endometrioma referred to Shahid Beheshti Hospital in Isfahan will be included in the study and will be randomly divided into 2 groups. One group will receive vasopressin and the other group will receive a placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria include diagnosis of unilateral ovarian endometrioma by ultrasound, the size of the cyst should be between 30 and 70 mm, lack of evidence of ovarian cancer, normal menstrual cycle, and individuals with symptomatic endometrioma and surgical indications. Exclusion criteria include patient’s pregnancy, body mass index above 30 kg/m², history of any malignancy, detection of ovarian cysts other than endometrioma after surgery, atypical endometrioma, history of kidney, liver, and heart diseases, use of combined contraceptive pills before surgery, previous surgery of endometrioma, and polycystic ovary syndrome.
Intervention groups
Intervention group: In this group, 20 units of diluted vasopressin will be diluted by 200 times during surgery. The mentioned injection will be followed by 30-40 ml of normal saline will be injected into the ovaries in different spaces. Control group: In this group, the first 3 ml of normal saline will be injected in one to three points similar to those of the intervention group, and then another 30-40 ml of normal saline will be injected into the ovarian space completely similar to that of the intervention group.
Main outcome variables
Number of antral ovarian follicles; Serum levels of anti mullerian hormone

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N26
Registration date: 2021-03-30, 1400/01/10
Registration timing: registered_while_recruiting

Last update: 2021-03-30, 1400/01/10
Update count: 0
Registration date
2021-03-30, 1400/01/10
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ovarian reserve in laparoscopic endometrioma surgery with and without vasopressin injection
Public title
Comparison of ovarian reserve in laparoscopic endometrioma surgery with and without vasopressin injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of unilateral ovarian endometrioma by ultrasound The size of the cyst should be between 30 and 70 mm Lack of the evidence of ovarian cancer Normal menstrual cycle Individuals with symptomatic endometrioma and surgical indications (infertility, failed assistedreproductive technology (ART) treatment cycles, pelvic pain)
Exclusion criteria:
Patient’s pregnancy Body mass index above 30 kg/m² History of any malignancy Detection of ovarian cysts other than endometrioma after surgery Atypical endometrioma History of kidney, liver, and heart diseases (hypertension - cardiac arrhythmia - ischemia) Use of combined contraceptive pills before surgery (over the last three months) Previous surgery of endometrioma Polycystic ovary syndrome
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
En In this study, 44 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, vasopressin and placebo are pre-prepared and placed in coded packages, and delivered daily to the relevant specialist. She prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.MUI.MED.REC.1399.1046

Health conditions studied

1

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

Primary outcomes

1

Description
Number of antral ovarian follicles
Timepoint
Before and three months after surgery
Method of measurement
Transvaginal ultrasound

2

Description
Serum levels of anti mullerian hormone
Timepoint
Before and three months after surgery
Method of measurement
Kit made by Biomeriux company

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, 20 units of diluted vasopressin (Elixir Pharmaceutical Company) will be diluted by 200 times (0.1 units per ml) during surgery. 3 ml of diluted vasopressin will be injected at one to three points near the great vessels, with the exception of the area of the ovarian hilus, and between the cyst space and the ovarian parenchyma, so that 0.3 units of vasopressin will be used for each patient. The mentioned injection will be followed by 30-40 ml of normal saline will be injected into the ovaries in different spaces for the hydro dissection and the prevention of vasopressin complications including arrhythmias.
Category
Treatment - Surgery

2

Description
Control group: In this group, first 3 ml of normal saline will be injected in one to three points similar to those of the intervention group, and then another 30-40 ml of normal saline will be injected into the ovarian space completely similar to that of the intervention group.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Safoura Rouholamin
Street address
Motahari Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
s_rouholamin@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Safoura Rouholamin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
s_rouholamin@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safoura Rouholamin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
s_rouholamin@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Moghare abed
Position
Non-faculty sub-specialist
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
moghreabed@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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