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IRCT20220215054030N1 IRCT 2022-04-20 Sabzevar University of Medical Sciences effect of cryotherapy in the treatment of mild cervical dysplasia(grade I ) - 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 2022-02-21 anticipated 50 Complete https://irct.ir/trial/62072 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, 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 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. 3 Mild cervical dysplasia. Intervention 1: 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 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Elham jananeh
No 4/98, Kushei squ, Beheshty st, Kohsangi st.
Mashhad Iran (Islamic Republic of) 9175864197 +98 21 3845 9831 hbeiki@qiet.ac.ir Sabzevar University of Medical Sciences scientific Elham Jananeh
Sabzevar med university
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8101 vc.Research@medsab.ac.ir Sabzevar University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Female 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 N87.0 Dysplasia of cervix, low grade cin 1 Treatment - Other Treatment - Other 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 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. Mild cervical dysplasia. Timepoint: onset(before & after of intervention) & after7 days& 6 month of intervention. Method of measurement: Questionnaire and examination and pathology results. Sabzevar University of Medical Sciences Approved 2022-02-16 Ethics committee of Sabzevar University o f Medical Sciences Central building of Sabzevar University of Medical Sciences, tohid shahr St., Sabzevar, Razavi khorasan, Iran. Sabzevar Razavi Khorasan Iran (Islamic Republic of)