Comparison of ovarian reserve after abdominal hysterectomy with& without bilateral salpingectomy in women in reproductive age
Design
Randomized clinical trial with a control group,parallel groups, no blinding,with 60 patients in two groups of 30 and computer-designed randomization method was used for randomization.
Settings and conduct
In this clinical trial study, all eligible patients of childbearing age will enter the study at the Rouhani Hospital in Babol during the year2021. This surgery is performed by an experienced surgical team of obstetricians and gynecologists of Babol University of Medical Sciences. In patients, ultrasound and tests will be repeated 3 months later
Participants/Inclusion and exclusion criteria
Patients of reproductive age; No history of oligo menorrhagia; Candidate for abdominal hysterectomy with ovarian preservation; No menopausal symptoms and FSH less than 10 units / liter
Patients with premenopause or a family history of genital or breast cancers; Reported ovarian cyst; History of taking hormonal drugs during the two months before surgery
Intervention groups
Intervention: Patients in this group underwent abdominal hysterectomy. After round ligament amputation,the eutrophic ligament is isolated instead of infendibloplovik and the ovary (one or both ovaries) is preserved and then, according to the routine protocol of arterial and uterine vein surgery, ligament The cardinal and vaginal cuffs are separated and the uterus and fallopian tubes are removed
Control group: Patients in this group during abdominal hysterectomy at the junction of the tubes to the uterus as well as the ectopic ligament are separated and the tubes and ovaries (one or both ovaries and tubes) are preserved. The vagina is removed and the uterus is removed.
Main outcome variables
Comparison of changes in serum levels of antimullerian hormone in the three months after surgery in the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210911052439N1
Registration date:2021-10-03, 1400/07/11
Registration timing:registered_while_recruiting
Last update:2021-10-03, 1400/07/11
Update count:0
Registration date
2021-10-03, 1400/07/11
Registrant information
Name
mahboobeh mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3220 8726
Email address
mahboobehmohammadpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ovarian reserve after abdominal hysterectomy with& without bilateral salpingectomy in women in reproductive age.
Public title
Ovarian reserve after abdominal hysterectomy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients in reproductive age without a history of oligomenorrhea who candidates for hysterectomy.
Patients with no menopausal symptoms and FSH levels less than 10 units / liter.
Patients who are candidates for abdominal hysterectomy without oophorectomy because of benign reasons.
Exclusion criteria:
Patients in premenopausal age.
Patients with a family history of genital or breast cancers.
Patients whose ovarian cysts have been reported in previous ultrasound examinations.
Patients who have a history of taking hormonal or ocp medications within two months before surgery.
Age
To 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of 30 using 6 blocks and a ratio of 1: 1. The free website www.randomization.com will be used for the allocation sequence. The obtained sequence will be written in separate sheets and will be placed in sealed envelopes and will be given to the main researcher for study.
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 Babol university of medical sciences
Street address
Daveshjoo 5, keshavarz Blvd.
City
Babol
Province
Mazandaran
Postal code
47176-59964
Approval date
2021-08-31, 1400/06/09
Ethics committee reference number
IR.MUBABOL.REC.1400.216
Health conditions studied
1
Description of health condition studied
Ectopic pregnancy
ICD-10 code
O00.1
ICD-10 code description
Tubal pregnancy
Primary outcomes
1
Description
Anti-Mullerian Hormone level
Timepoint
At the beginning of the study and three months after hysterectomy
Method of measurement
Chemiluminescence method
Secondary outcomes
1
Description
Follicle-stimulating Hormone (FSH) level
Timepoint
At the beginning of the study and three months after hysterectomy
Method of measurement
Chemiluminescence method
2
Description
Number of antral follicles OF ovary
Timepoint
At the beginning of the study and three months after hysterectomy
Method of measurement
Sonography
3
Description
Ovarian volume
Timepoint
At the beginning of the study and three months after hysterectomy
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: Patients in this group underwent abdominal hysterectomy. After round ligament amputation, the eutrophic ligament was isolated instead of infendibliplovik and the ovary (one or both ovaries) was preserved and then the cardinal ligament and vaginal cuff were isolated according to the routine protocol of arterial and venous surgery. And the uterus and fallopian tubes come out.
Category
Treatment - Surgery
2
Description
Control group: Patients in this group undergo abdominal hysterectomy at the junction of the fallopian tubes and the uterine ligament and the fallopian tubes and ovaries (one or both ovaries and fallopian tubes) are preserved. And the uterus comes out.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani hospital
Full name of responsible person
Azita Ghanbarpour
Street address
Ganj afrooz Ave.,Keshavarz Blvd.,Babol.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
+98 11 3229 0181
Email
rohani@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47754
Phone
+98 11 3219 0558
Fax
+98 11 3219 7667
Email
research@mubabol.ac.ir
Web page address
https://research.mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mahboobeh Mohammadpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Daneshjoo5,.Keshavarz Blvd.
City
Babol
Province
Mazandaran
Postal code
47176-59964
Phone
+98 11 3220 8726
Email
mahboobehmohammadpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Azita Ghanbarpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ganj afrooz Ave.,Keshavarz Blvd.,Babol.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
+98 11 3229 0181
Email
a.ghanbarpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahboobeh Mohammadpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Daneshjoo5,.Keshavarz Blvd.
City
Babol
Province
Mazandaran
Postal code
47176-59964
Phone
+98 11 3220 8726
Email
mahboobehmohammadpour@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All procedures performed, including how patients are selected, laboratory procedures and ultrasound, and the procedure performed during surgery and how patients are followed up after the study will be shared.
When the data will become available and for how long
The access period will start one year after the results are published.
To whom data/document is available
Academics, researchers, and students, can access the study.
Under which criteria data/document could be used
All analyzes are performed in order to make better and more use of the research and to upgrade the knowledge and surgical processes.
From where data/document is obtainable
mahboobehmohammadpour@gmail.com
00989111191874
What processes are involved for a request to access data/document
After viewing the email and verifying the identity of the applicant, the data file will be provided.