The effect of misoprostol on removal endometrial polyp
Design
A non-randomized control trial, without control group, Phase 2, 30 patients
Settings and conduct
30 infertile women will be diagnosed with the primary endometrial polyp using vaginal sonography with color doppler. Saline infusion sonography will be performed for the confirmation of the diagnosis. After that patients will receive misoprostol. A repeated vaginal sonography with color doppler will perform 8 hours later. Hysteroscopy will perform for all patients to evaluate the treatment effect of misoprostol.
Participants/Inclusion and exclusion criteria
Infertile women with endometrial polyp
Intervention groups
Misoprostol administration for women with endometrial polyp
Main outcome variables
Endometrial polyp removal
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200305046702N2
Registration date:2020-10-31, 1399/08/10
Registration timing:registered_while_recruiting
Last update:2020-10-31, 1399/08/10
Update count:0
Registration date
2020-10-31, 1399/08/10
Registrant information
Name
Zhhreh Pezeshkpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
z.pezeshkpour@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of misoprostol on removal endometrial polyp
Public title
Misoprostol and endometrial polyp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Endometrial polyp in normal saline sonography
Infertility
45>=Age>=18
Exclusion criteria:
Uterus malformation
Sensitivity to prostaglandin analogs
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:
30
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 Yazd Reproductive Sciences Institute.
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2020-07-19, 1399/04/29
Ethics committee reference number
IR.SSU.RSI.REC.1399.010
Health conditions studied
1
Description of health condition studied
Endometrial polyp
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Endometrial polyp removal
Timepoint
8 hours after misoprostol administration
Method of measurement
Vaginal sonography, hystroscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Each patient recieve tow tablet of 200 microgram misoprostol(cytotec):in the manner 200 micro gram vaginal and 200 micro gram oral at the same time.Afther eight hours each patient evaluate by transvaginal sonography with color doppler in terms of removal endometrial polyp.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7085
Email
z.pezeshkpour@stu.ssu.ac.ir
Web page address
https://www.yazd-rsi.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaiee
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
z.pezeshkpour@stu.ssu.ac.ir
Web page address
https://ssu.sc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zohreh Pezeshkpour
Position
Fellowship student
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
z.pezeshkpour@stu.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zhhreh Pezeshkpour
Position
Felowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd,Safaeiye,Bouali Ave,Research and Clinical center for infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
Z.pezeshkpour@stu.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zohre pezeshkpour
Position
Fellowship student
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safayieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
z.pezeshkpour@stu.ssu.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
The data could be shared after de--identification
When the data will become available and for how long
Data could be available 1 year after publication
To whom data/document is available
Researchers in scientific institutes or universities
Under which criteria data/document could be used
No one
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
As soon as the researchers request to have the data