Determining the mechanical effect of Uterine artery ligation on ovarian reserve during myomectomy laparotomy
Design
The study is before and after, without blinding, with a sample size of 32
Settings and conduct
All initial patient information, including age, initial BMI.AMH and after 3 months of operation, the size of the myoma in ultrasound, the menstrual pattern, and the history of abdominal surgery, will be collected in the form of data collection that will be adjusted for this purpose. Information required from A complete initial biography that will be taken from each individual patient will be provided as well as birth certificate information, patient's medical history, surgery descriptions, laboratory data. All of this information is included in the pre-prepared review form that is attached, will be completed for each subject.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Infertility in a person with ovarian factor
No PCO
Not having endometriosis (BMI <30)
Regular menstrual pattern
Having informed consent to enter the study
Exclude criteria: Dissatisfaction with entering the study
People who the specialist discovers that treatment can be at risk for them.
A person who is likely to be unavailable at a later date for subsequent tests.
Intervention groups
Intervention group: open myomectomy surgery (laparotomy)
Main outcome variables
AMH after 3 months,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150817023666N10
Registration date:2018-02-17, 1396/11/28
Registration timing:prospective
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mechanical effect of uterine artery ligation on ovarian reserve during myomectomy laparotomy
Public title
Effect of tourniquet ligation on ovarian reserve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility in person with ovarian factor
No PCO
No endometriosis (BMI <30)
Regular menstrual pattern
informed consent to enter the study
Exclusion criteria:
Dissatisfaction to enter the study
The person the practitioner determines that treatment can be at risk for them
A person who is likely to be unavailable at a later date for subsequent tests
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
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 Iran University of Medical Sciences
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2018-01-24, 1396/11/04
Ethics committee reference number
IR.IUMS.REC 1394.25946
Health conditions studied
1
Description of health condition studied
Leiomyoma of uterus
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
AMH serum level measurement
Timepoint
Measurement of baseline serum level and 3 months later
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: uterine artery ligation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e Rasoul-e- Akram Hospital
Full name of responsible person
Abolfazl mehdizadeh-kashi
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 21 6435 2680
Email
amehdizadehkashi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 6435 2680
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh-kashi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 21 6435 2680
Email
amehdizadehkashi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 21 6435 2680
Email
s.rokhgireh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Rokhgireh
Position
Assistant profesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Fax
+98 21 6435 2680
Email
s.rokhgireh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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