Evaluation the effect of cryotherapy in the treatment of mild cervical dysplasia(grade I ) in comparison with the expected treatment in patients who referred to Sabzevar gynecological oncology center
Efficacy of cryotherapy in treatment of mild cervical dysplasia in patients referred to oncology gynecology center of Sabzevar compared to expectant management
Design
This clinical trial with the control group is performed in parallel-group, double-blind, randomized in phase 3 on100 patients.Samples will be randomly assigned to four blocks .
Settings and conduct
This blinded clinical trial was performed in Sabzevar gynecology-oncology clinic on patients with diagnosis of cin1 were already diagnosed by colposcopy.Necessary information, previous reports of pap sear, and colposcopy biopsies are recorded in a questionnaire. The women with CIN1 are just enrolled in the study. They are divided into two equal groups of fifty: control and intervention.The control group receives Cr yo-placebo and the intervention group receives true cryotherapy.Patients are examined before of intervention, and1and 3 months later.Colposcopy and biopsy are done for all of participants 6 months after treatment.
Outcome: The main outcome is histology improvement of mild cervical dysplasia which will be compared in two groups statistically through Q-square test.
Participants/Inclusion and exclusion criteria
All women with diagnosis of CIN1 who referred to the gynecology oncology clinic
Intervention groups
Control: The trained operator inserts the prob into the patient's vagina but it does not make contact between the prob and the cervix. After about 3 to 5 minutes, the device turns off and the prob comes out. Intervention: The trained operator takes the cryotherapy prob in contact with the cervix. She holds it for about 3 to 5 minutes until forming ice ball in position for every patient.
Main outcome variables
Mild cervical dysplasia
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20220215054030N1
Registration date:2022-04-20, 1401/01/31
Registration timing:registered_while_recruiting
Last update:2022-04-20, 1401/01/31
Update count:0
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Elham Jananeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 9831
Email address
hbeiki@qiet.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-21, 1400/12/02
Expected recruitment end date
2023-08-24, 1402/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of cryotherapy in the treatment of mild cervical dysplasia(grade I ) in comparison with the expected treatment in patients who referred to Sabzevar gynecological oncology center
Public title
effect of cryotherapy in the treatment of mild cervical dysplasia(grade I )
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women referred to the gynecological oncology center,who were diagnosed with cin1 in the studies
Be at least 18 years old
Absence of menopause
Negative pregnancy test
Satisfactory colposcopy or Negative endocervical curettage
Lesions limited to the exocervix
Satisfaction with cooperation
low-grade CIN on the basis of historically
Exclusion criteria:
Failure to complete the course of treatment
Do not refer to follow-ups
Use other treatments at the same time
Pregnancy
Extending lesion(s) to the vaginal
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization. Block randomization with block size of four will be used. Random Allocation software will be used to generate the stochastic sequence. According to the randomly generated sequences, patients enter the control group and the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University o f Medical Sciences
Street address
Central building of Sabzevar University of Medical Sciences, tohid shahr St., Sabzevar, Razavi khorasan, Iran.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2022-02-16, 1400/11/27
Ethics committee reference number
IR.MEDSAB.REC.1400.157
Health conditions studied
1
Description of health condition studied
Mild cervical dysplasia
ICD-10 code
N87.0
ICD-10 code description
Dysplasia of cervix, low grade cin 1
Primary outcomes
1
Description
Mild cervical dysplasia
Timepoint
onset(before & after of intervention) & after7 days& 6 month of intervention
Method of measurement
Questionnaire and examination and pathology results
Secondary outcomes
empty
Intervention groups
1
Description
Control: The trained operator inserts the prob into the patient's vagina but it does not make contact between the prob and the cervix. After about 3 to 5 minutes, the device turns off and the prob comes out.
Category
Treatment - Other
2
Description
Intervention group: The trained operator takes the cryotherapy prob in contact with the cervix. She holds it for about 3 to 5 minutes until forming ice ball in position for every patient.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar gynecological oncology center
Full name of responsible person
Dr Jilla Agah
Street address
Mobini hospital, Kashefi st.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8101
Fax
+98 51 4401 8102
Email
vcResearch@medsab.ir
Web page address
http://vcResearch.medsab.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
ِِDr Mohhammad hossein Saghi
Street address
2th Floor, Central building of Sabzevar University of Medical Sciences, tohid shahr St., Sabzevar, Razavi khorasan, Iran.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8101
Fax
+98 51 4401 8102
Email
vcResearch@medsab.ac.ir
Web page address
http://vcResearch.medsab.ac.ir
Grant name
Vice Chancellor for Research & Technology of Sabzevar University of Medical Sciences
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
30
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
Sabzevar University of Medical Sciences
Full name of responsible person
Elham jananeh
Position
Genicology&obstractive resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 4/98, Kushei squ, Beheshty st, Kohsangi st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175864197
Phone
+98 21 3845 9831
Fax
+98 21 3845 9831
Email
hbeiki@qiet.ac.ir
Web page address
http://www.hbeiki.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Elham Jananeh
Position
Genicology & obstractive resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sabzevar med university
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8101
Fax
+98 51 4401 8102
Email
vc.Research@medsab.ac.ir
Web page address
http://vc.Research.medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Elham jananeh
Position
Genicology & obstractive resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 4/98, Kushei squ, Beheshty st, Kohsangi st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175864197
Phone
+98 51 3845 9831
Fax
+98 51 3845 9831
Email
hbeiki@qiet.ac.ir
Web page address
http://hbeiki@qiet.ac.ir
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