Comparison of ovarian reserve pre- and post salpingectomy with hysterectomy
Design
Clinical trial on 25 female patients under 45 years of age who were candidates for hysterectomy due to benign disease.
Settings and conduct
For patients undergoing hysterectomy with salpenectomy, the amount of ovarian reserve is determined on the day before surgery by blood sampling (2 cc) and sending a sample to measure antimullerian hormone using luminescence immunochemistry kit. 3 months after the operation, again and in the same laboratory and with the same kit, the amount of antimullerian hormone is determined and then the comparison of ovarian reserve before and after the operation is done using t-test of two independent samples.
Participants/Inclusion and exclusion criteria
Inclusion: Women under 45 years old who candidates for hysterectomy due to benign disease with no history of surgery on ovaries and tubes
Exclusion: Women over 45 years old - uterin or ovarian malignancies - Early ovarian failure - Previous history of oophorectomy - Low preoperative AMH level
Intervention groups
Salpingectomy is also performed in women under the age of 45 years who are candidates for hysterectomy.
Main outcome variables
ovarian reserve
Reduction of ovarian cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120922010901N8
Registration date:2020-12-29, 1399/10/09
Registration timing:registered_while_recruiting
Last update:2020-12-29, 1399/10/09
Update count:0
Registration date
2020-12-29, 1399/10/09
Registrant information
Name
Parvin Mostafa Gharebaghi
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
gharabagh.p@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of salpingectomy during hysterectomy on ovarian reserve :before and after clinical trial
Public title
The effect of salpingectomy on ovarian reserve
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Women under 45 years is a candidate for histerectomy
Exclusion criteria:
Malignant disease
women under 15 years
premature ovarian failure before surgery
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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
Alzahra hospital,bagh_e shomal square
City
Tabriz
Province
East Azarbaijan
Postal code
5157695774
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.TBZMED.REC.1398.1073
Health conditions studied
1
Description of health condition studied
Ovarian reserve following salpingectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in AMH levels following salpingectomy
Timepoint
AMH measurement the day before surgery and again three months after surgery
Method of measurement
From a blood sample with the same luminescence immunoassay (ICL) kit in the laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women under 45 years of age are candidates for hysterectomy due to benign diseases in which salpingectomy is performed simultaneously with hysterectomy and the amount of antimullerian hormone is compared before surgery and three months after surgery.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mustafa Gharabaghi Parvin
Street address
Bagh_e shomal square
City
Tabriz
Province
East Azarbaijan
Postal code
5157695774
Phone
+98 41 3553 7492
Email
Pm_gharabaghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mustafa Gharabaghi Parvin
Street address
Artesh Jonobi Ave ,Bagheshomal square
City
Tabriz
Province
East Azarbaijan
Postal code
5157695774
Phone
+98 41 3553 7492
Email
Pm_gharabaghi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
90
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
Mustafa Gharabaghi Parvin
Position
rofessor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Bagheshomal square, Artesh Jonobi
City
Tabriz
Province
East Azarbaijan
Postal code
5157695774
Phone
+98 41 3553 7492
Email
Pm_gharabaghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mustafa Gharabaghi Parvin
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Bagheshomal square,Artesh Jonobi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5157695774
Phone
+98 41 3553 7492
Email
Pm_gharabaghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mustafa gharabaghi parvin
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Bagheshomal square,Artesh Jonobi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5157695774
Phone
+98 41 3553 7492
Email
Pm_gharabaghi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
After analyzing the data, a decision will be made
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
After analyzing the data, a decision will be made
Under which criteria data/document could be used
After analyzing the data, a decision will be made
From where data/document is obtainable
After analyzing the data, a decision will be made
What processes are involved for a request to access data/document