Evaluation of the effect of temporary and permanent uterine artery ligation to control bleeding on ovarian reserve using anti-Mullerian hormone (AMH) measurement in laparoscopy.
Design
A clinical trial with a control group and two intervention groups on 54 patients and study type is parallel.
Settings and conduct
The study population included patients undergoing laparoscopic myomectomy in the age range of 18 to 45 years who referred to Shahid Beheshti Hospital in 2023.Patients are sub divided in 3 groups. The first group has an inappropriate location of the uterine artery and the second one has patients who want to preserve the uterus but do not want to become pregnant who are in the permanent group and the third group are patients who have infertility and are planning to become pregnant in the future.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age between 18 and 45 years old who have a maximum of 3 myoma and less than 10 cm or symptomatic myomas. Exclusion criteria: History of receiving hormonal therapy or history of previous surgery on the ovary.
Intervention groups
In the intervention group, before myomectomy to control the bleeding of the uterine artery from the beginning of separation from the hypogastric artery is temporarily or permanently closed and in the control group vasopressin is injected in the myoma capsule to control the bleeding.
Main outcome variables
Checking the ovarian reserve after the operation and checking the amount of bleeding during the operation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230519058228N2
Registration date:2023-08-17, 1402/05/26
Registration timing:registered_while_recruiting
Last update:2023-08-17, 1402/05/26
Update count:0
Registration date
2023-08-17, 1402/05/26
Registrant information
Name
Maryam Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 7860
Email address
maryam.hashemi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of temporary and permanent uterine artery ligation(UAL) on ovarian reserve in laparoscopic myomectomy patients.
Public title
The effect of uterine artery ligation on fertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between 18 and 45 years old
Patients with up to 3 myomas
Myomas smaller than 10 cm
Patients with symptomatic myomas
Exclusion criteria:
History of receiving hormone therapy
History of previous surgery on the ovary
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan, Hezar Jerib St ,Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.MUI.MED.REC.1402.140
Health conditions studied
1
Description of health condition studied
Uterine myoma
ICD-10 code
D25.9
ICD-10 code description
Leiomyoma of uterus, Unspecified
Primary outcomes
1
Description
Evaluation of ovarian reserve (AMH) after laparoscopic myomectomy
Timepoint
Before and 3 months after the operation
Method of measurement
Taking a blood sample from the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In women with uterine myoma who have indications for laparoscopy, before starting myomectomy to control bleeding, the uterine artery is temporarily closed and the amount of bleeding will be recorded at the end of the procedure. Patients' tests are reviewed before and 3 months after the study.
Category
Treatment - Surgery
2
Description
Intervention group 2: In women with uterine myoma who have indications for laparoscopy, before starting myomectomy to control bleeding, the uterine artery is permanent closed and the amount of bleeding will be recorded at the end of the procedure. Patients' tests are reviewed before and 3 months after the study.
Category
Treatment - Surgery
3
Description
Control group: In women with uterine myoma who have indications for laparoscopy, vasopressin injection will be used to control bleeding before starting myomectomy, and the amount of bleeding will be recorded at the end of the procedure. Patients' tests are reviewed before and 3 months after the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Isfahan city
Full name of responsible person
Maryam Hashemi
Street address
Shahid Beheshti Hospital,Shahid Motahhari street ,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
maryam.hashemi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Asgari
Street address
Esfahan University of Medical Science, Hezar Jerib Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Maryam Hashemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3775 4892
Email
maryam.hashemi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Hashemi
Position
Asisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7860
Email
marayam.hashemi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Hashemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Esfahan University of Medical Science, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7860
Email
maryam.hashemi@med.mui.ac.ir
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
The data will not be shared separately, but the results of their analysis will be shared in the article