Ovarian Reserve Assessment Before and After Laparoscopic Cystectomy
Design
Clinical trial on 90 patients.no blinded
Settings and conduct
This study will be performed on 90 patients with ovarian cysts in reproductive ages 15-35 years who refer to Al-Zahra Hospital in Tabriz and undergo laparoscopic resection of ovarian cysts due to the need for surgery. The combination of suturing and electrocoagulation with bipolar instruments will be used to control homeostasis, so that the minimum amount of ovarian cautery will be used to prevent ovarian reserve loss, and where necessary, sutures will be used to control homeostasis.)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women at fertility age between 15 and 35 years; with ovarian cysts 3 to 10 cm in size and requiring surgery.
Non-inclusion criteria: Evidence of ovarian cancer; Menopause; Pregnant patients; Patients with advanced chronic diseases; Before menarche; Ovarian torsion
Intervention groups
Ninety patients diagnosed with non-endometrioma ovarian cysts will undergo laparoscopic ovarian cyst resection surgery. All surgeries in this study will be performed by a gynecologist. Combination of suctioning and electrocoagulation with bipolar instruments will be used to control homeostasis. The minimum amount of ovarian cautery will be used to prevent the loss of ovarian reserve, and where necessary, suture will be used to control homeostasis.
Main outcome variables
Serum levels of antimullerian hormone (AMH); Serum levels of follicle-stimulating hormone (FSH); Ovarian volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211103052950N2
Registration date:2022-02-09, 1400/11/20
Registration timing:registered_while_recruiting
Last update:2022-02-09, 1400/11/20
Update count:0
Registration date
2022-02-09, 1400/11/20
Registrant information
Name
Fatemeh Tabatabaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3326 2754
Email address
drtabatabaeigyn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of ovarian reserve before and after laparoscopic cystectomy in patients with ovarian cyst in need of surgery.
Public title
Ovarian Reserve Assessment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women at fertility age between 15 and 35 years
With ovarian cysts 3 to 10 cm in size and requiring surgery
Exclusion criteria:
Evidence of ovarian cancer
Post menopausal patients
Pregnant patients
History of multiple previous surgeries in more than two time
Patients with advanced chronic diseases
For any reason that the operation turns into a laparotomy
Before menarche
Ovarian torsion
Age
From 15 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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 Number 2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IR.TBZMED.REC.1400.912
Health conditions studied
1
Description of health condition studied
Ovarian cyst
ICD-10 code
N83.0
ICD-10 code description
Follicular cyst of ovary
Primary outcomes
1
Description
Ovarian Reserve
Timepoint
The third day of the last menstrual cycle before surgery - six months after surgery - one year after surgery
Method of measurement
laboratory kit
2
Description
Serum levels of antimullerian hormone (AMH)
Timepoint
The third day of the last menstrual cycle before surgery - six months after surgery - one year after surgery
Method of measurement
laboratory kit
3
Description
Serum level of FSH (follicular stimulating hormon)
Timepoint
The third day of the last menstrual cycle before surgery - six months after surgery - one year after surgery
Method of measurement
laboratory kit
Secondary outcomes
1
Description
Ovarian Volume
Timepoint
Two weeks after surgery - Six months after surgery - One year after surgery
Method of measurement
Ultrasound measurement of ovarian volume
Intervention groups
1
Description
Ninety patients diagnosed with non-endometrioma ovarian cysts will undergo laparoscopic ovarian cyst resection surgery. All surgeries in this study will be performed by a gynecologist. Combination of suctioning and electrocoagulation with bipolar instruments will be used to control homeostasis. The minimum amount of ovarian cautery will be used to prevent the loss of ovarian reserve, and where necessary, suture will be used to control homeostasis.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital of Tabriz
Full name of responsible person
Fatemeh Tabatabaei
Street address
Alzahra Hospital , Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
drtabatabaeigyn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Parviz Shahabi
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Tabatabaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra Hospital , Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
drtabatabaeigyn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Tabatabaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra Hospital , Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
drtabatabaeigyn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Tabatabaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra Hospital , Artesh Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
drtabatabaeigyn@gmail.com
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
All data is potentially shareable after making individuals unidentifiable
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions and people who working in industry
Under which criteria data/document could be used
By observing the principle of intellectual property and without making any changes or misapplication
From where data/document is obtainable
Scientific respondent to the study E-mail : drtabatabaeigyn@gmail.com
Dr. Fatemeh Tabatabaei
What processes are involved for a request to access data/document