Determining the effect of local vasopressin injection during laparoscopic cystectomy in patients with endometrioma on ovarian reserve
Design
This non blinded ,parallel, randomized clinical trial (phase II) with control group is performed on 100 women aged 18-45 years .
For randomization we used the random function of Excel software.
Settings and conduct
All surgeries are performed by a surgeon at a private referral hospital(Dena Hospital, Shiraz, Iran). In the intervention group, 5 cc of vasopressin solution (10 units in 20 cc of normal saline) is injected into the mesoovarium and then cystectomy for ovarian endometriosis is performed.
Then we examine and compare the difference of ovarian reserve in each group using SPSS 18.0 software with an error coefficient of 5%.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age 18-45
Unilateral endometrioma
Exclusion criteria:Bilateral endometrioma
Menopausal women
Any contraindication for surgery
Intervention groups
In the intervention group, 5 cc of vasopressin solution (10 units in 20 cc of normal saline) is injected into the ovary and in the control group, no intervention is performed.
Main outcome variables
In both groups, an anti mullerian hormone (AMH) as an ovarian reserve test is performed one , three , six and nine months after operation.
The number of cauterization points required for homeostasis and bleeding amount during procedure in both groups are compared.
Then we examine and compare the difference in rate of (AMH) in each group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200925048836N1
Registration date:2020-10-26, 1399/08/05
Registration timing:retrospective
Last update:2020-10-26, 1399/08/05
Update count:0
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
Elham Askary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
elliaskary_md@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-29, 1398/07/07
Expected recruitment end date
2020-09-28, 1399/07/07
Actual recruitment start date
2019-09-29, 1398/07/07
Actual recruitment end date
2020-09-28, 1399/07/07
Trial completion date
2021-03-02, 1399/12/12
Scientific title
Evaluation the effect of vasopressin injection during operation of endometrioma on the ovarian reserve in reproductive age endometriotic women.
Public title
Evaluation the effect of vasopressin in ovarian endometriosis surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45
With unilateral endometriosis of the ovaries undergoing cystectomy
Exclusion criteria:
Bilateral endometrioma
Menopausal women
Any contraindication for surgery
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Shiraz Ethics Committee in Medical School Research
Street address
Zand Blvd, Faghihi hospital OB& GYN ward
City
Shiraz
Province
Fars
Postal code
07134814336
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
IR.SUMS.MED.REC.1396.59
Health conditions studied
1
Description of health condition studied
Treatment of ovarian endometrioma
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Ovarian reserve
Timepoint
0,3,6 Months post operation
Method of measurement
Blood sampling
Secondary outcomes
1
Description
The number of cauterization points needed for homeostasis
Timepoint
At time of operation
Method of measurement
The number of points that are catheterized by a bipolar Bissinger Medizintechnik device to perform homeostasis during a cystectomy is counted and recorded.
2
Description
The amount of bleeding (milliliter) in both groups were recorded.
Timepoint
At time of operation
Method of measurement
Amount of bleeding (milliliter) is measured according to suction device measuring.
Intervention groups
1
Description
Intervention group: in the intervention group, 5 cc of vasopressin solution(Hay press, Exir Pharmaceutical company, Iran) (10 milli intensive units in 20 cc of normal saline) is injected into the avascular part of meso ovarium and then cystectomy is performed by an expert surgone with laparoscopic methods,the point of bleeding coagulated with bipolar Bissinger Medizintechnik device and amount of bleeding is recorded according to suction device content /milliliter, then the ovarian wall is sutured .
Category
Treatment - Surgery
2
Description
Control group: In the control group, without injection of vasopressin, ovarian cystectomy is performed by a skilled surgeon with laparoscopic method . Number of ovarian cauterization points that is performed wit Bissinger Medizintechnik bipolar device for homeostasis and the amount of bleeding during cyst removal is measured in milliliters that are collected in the suction device during surgery, then ovarian wall suturing is performed
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Refferal Private Dena Hospitaا
Full name of responsible person
Saeed Alborzi
Street address
Faghihi Hospital Office of Obstetrics and Gynecology
City
Shiraz
Province
Fars
Postal code
07134814336
Phone
+98 71 3233 2365
Email
elliaskary_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbass Rezaeean
Street address
Zand Blvd, Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
07134814336
Phone
+98 71 3235 7282
Email
rezaiana@sums.ac.ir
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 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
Shiraz University of Medical Sciences
Full name of responsible person
Saeed Alborzi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Blvd, Faghihi Hospital, OB&GYN central office
City
Shiraz
Province
Fars
Postal code
07134814336
Phone
+98 71 3233 2356
Email
alborzisa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Askari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Blvd, Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
07134814336
Phone
0712332365
Email
elliaskary_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Askari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand
City
Shiraz
Province
Fars
Postal code
07134814336
Phone
+98 71 3233 2365
Email
elliaskary_md@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Using vasopressine causes less bleeding and therefore does not reduce ovarian reserve after surgery
When the data will become available and for how long
Until the publication of the article
To whom data/document is available
Main and corresponding authors
Under which criteria data/document could be used
With respect to inclusion and exclusion criteria
From where data/document is obtainable
Main author
What processes are involved for a request to access data/document
Collected by the first author and evaluated by the documentary team and converted into statistical data