1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
The Impact of Temporary Ovarian Ischemia due to Uterine Turnicate application at the time of Myomectomy: Before-after study
Protocol summary
Summary
This study aimed to the impact of temporary ovarian ischemia due to uterine turnicate application at the time of Myomectomy. After confirming the inclusion criteria and obtain the written consent of the individual, Persons entered this study. Then before patients undergoing open myomectomy (laparotomy) surgery, peripheral blood sample would take to assess serum levels of Anti Mullerian Hormone base. The patients after surgery then will be assessed Anti Mullerian Hormone levels and changes 3 month later. Sample size in study is 32 patients. The primary outcome is the Anti Mullerian Hormone levels assessed by peripheral blood sample.
The inclusion criteria included, Lack of infertility in patients with ovarian factor, No Poly Cystic Ovary, No endometriosis, Body Mass Index <30, Regular menstrual pattern, an informed consent for inclusion.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2016050723666N2 Registration date: 2016-08-13, 1395/05/23 Registration timing: registered_while_recruiting
Last update:
Update count: 0 Registration date
2016-08-13, 1395/05/23 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
[email protected] Recruitment status
Recruitment complete Funding source
Iran University of Medical Sciences
Expected recruitment start date 2016-06-20, 1395/03/31
Expected recruitment end date 2017-06-20, 1396/03/30 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
The Impact of Temporary Ovarian Ischemia due to Uterine Turnicate application at the time of Myomectomy: Before-after study
Public title
The Impact of Temporary Ovarian Ischemia due to Uterine Turnicate application at the time of Myomectomy Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Lack of infertility in patients with ovarian factor, No Poly Cystic Ovary, No endometriosis, Body Mass Index <30, Regular menstrual pattern, An informed consent for inclusion Exclusion criteria: No informed consent for inclusion, Patients that their physician determines that treatment could be associated with risk.
Age
No age limit Gender
2 Female
Phase 1-2
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 Science Street address
Iran . Tehran . Hemat Highway . Milad Tower City
Tehran Postal code Approval date
2016-01-31, 1394/11/11
Ethics committee reference number 25946. IR.IUMS.REC.1394
Health conditions studied
1
Description of health condition studied Myomectomy
ICD-10 code N71.0
ICD-10 code description
Acute inflammatory disease of uterus
Primary outcomes
1
Description
Anti Mullerian Hormone Timepoint
Before and 3 months after surgery Method of measurement
Bleeding sample
Secondary outcomes empty
Intervention groups
1
Description
Intervention: Myomectomy surgery (uterine artery ligation)
Category Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center Rasoul-e-Akram Hospital Full name of responsible person
Abolfazal Mehdizadehkashi Street address
Niayesh Av. Sattar khan st. Tehran, Iran City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity Iran University of Medical Sciences Full name of responsible person
Ali Javad Musavi Street address
Vice chancellor for research, Iran University of Medical Sciences
City Tehran 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 empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding empty
3
Person responsible for general inquiries
Contact
Name of organization / entity Iran University of Medical Science Full name of responsible person
Abolfazl Mehdizadehkashi Position
professor of Obstetrics and Gynecology Other areas of specialty/work
Street address
Niayesh Av. Sattar khan st. Tehran, Iran City
Tehran Postal code
1449613131 Phone
+98 21 6650 9283 Fax
[email protected] Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity Iran University of Medical Science Full name of responsible person
Abolfazl MehdizadehKashi Position
Professor of Obstetrics and Gynecology Other areas of specialty/work
Street address
Niayesh Av. Sattar khan st. Tehran, Iran.
City Tehran Postal code
1449613131 Phone
+98 21 6650 9283 Fax
[email protected] Web page address
Person responsible for updating data
Contact
Name of organization / entity Iran University of Medical Science Full name of responsible person
Abolfazal Mehdizadehkashi Position
Professor of Obstetrics and Gynecology Other areas of specialty/work
Street address
Niayesh Av. Sattar khan st. Tehran, Iran.
City Tehran Postal code
1449613131 Phone
+98 21 6650 9283 Fax
[email protected] Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
