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IRCT20230522058253N2 IRCT 2023-10-26 Hamedan University of Medical Sciences Evaluation of the effect of quaternary HPV vaccine in the treatment of women with cervical intraepithelial neoplasia cin1 Evaluation of the effect of quaternary HPV vaccine in the treatment of women with cervical intraepithelial neoplasia cin1 2022-07-23 anticipated 300 Complete https://irct.ir/trial/73067 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be counseled upon entering the hospital and informed consent will be obtained from the patient. After entering the room, they are examined and then they are randomly assigned to one of the two groups. Randomization is done by writing the letters A and B on two sheets and putting them in a box, and one of these sheets is taken out by the researcher for each patient. After finishing, the sheets are removed again for the next two patients with this random method until we reach the desired sample size, Blinding description: The specialist who evaluates the patients is not aware of the treatment group or the person's placebo, and the design will be done in a blinded manner. 3 Evaluation of the effect of quaternary HPV vaccine in the treatment of women with cervical intraepithelial neoplasia cin1 of Fatemiye Hospitan, Hamadan. Intervention 1: Intervention group: Women in the intervention group will receive conservative treatment according to the ASCCP algorithm along with quadrivalent HPV vaccination (Gardasil). Gardasil targets HPV types 6, 11, 16 and 18. The vaccine will be administered as a series of intramuscular injections of 0.5 ml on day 1, month 2, and month 6. 48 to 72 hours after injection, patients will be examined for skin complications, fever, headache, pain and inflammation. During 2 years, patients will be followed up. The efficacy of the HPV vaccine in the treatment of CIN 1 will be defined as a primary outcome. To measure this criterion, women are visited three times (months 12, 18 ,24) and undergo gynecological examination and pap smear test, colposcopy and annual biopsy and in 18 24 undergo gynecological examination and pap smear test (in case of pap smear test suspicious) have been placed. At least two biopsy samples will be taken at the clinic. Colposcopy will be performed to evaluate the response to treatment despite the normal appearance of the cervix. Intervention 2: Control group: women in the control group will receive no HPV vaccination and placebo (vitamin B complex) according to the ASCCP algorithm. During 1.5 years, the patients will be followed up. The efficacy of the HPV vaccine in the treatment of CIN 1 will be defined as a primary outcome. To measure this criterion, women are visited three times (months 12, 18 ,24) and undergo gynecological examination and pap smear test, colposcopy and annual biopsy and in 18, 24 month undergo gynecological examination and pap smear test (in case of pap smear test suspicious) have been placed. At least two biopsy samples will be taken at the clinic. Colposcopy will be performed to evaluate the response to treatment despite the normal appearance of the cervix. 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 Decisions are made together with other authors.
public Mehrangiz Zamani bonab
Pastaran Ave
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7013 mehrangiz.zamani@umsha.ac.ir Hamedan University of Medical Sciences scientific Mehrangiz Zamani bonab
Hamadan
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7013 mehrangiz.zamani@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 21 to 45 years not currently pregnant not having had more than one sexual partner during their period received conservative treatment. women with histologically confirmed CIN 1 21 years 45 years Female women who became pregnant received only one dose of the vaccine, or allergic to the vaccine Those who have been cin 1 for more than 24 month Those who do not participate in the study (non-cooperation) will be excluded from the study Treatment - Drugs Placebo Intervention group: Women in the intervention group will receive conservative treatment according to the ASCCP algorithm along with quadrivalent HPV vaccination (Gardasil). Gardasil targets HPV types 6, 11, 16 and 18. The vaccine will be administered as a series of intramuscular injections of 0.5 ml on day 1, month 2, and month 6. 48 to 72 hours after injection, patients will be examined for skin complications, fever, headache, pain and inflammation. During 2 years, patients will be followed up. The efficacy of the HPV vaccine in the treatment of CIN 1 will be defined as a primary outcome. To measure this criterion, women are visited three times (months 12, 18 ,24) and undergo gynecological examination and pap smear test, colposcopy and annual biopsy and in 18 24 undergo gynecological examination and pap smear test (in case of pap smear test suspicious) have been placed. At least two biopsy samples will be taken at the clinic. Colposcopy will be performed to evaluate the response to treatment despite the normal appearance of the cervix. Control group: women in the control group will receive no HPV vaccination and placebo (vitamin B complex) according to the ASCCP algorithm. During 1.5 years, the patients will be followed up. The efficacy of the HPV vaccine in the treatment of CIN 1 will be defined as a primary outcome. To measure this criterion, women are visited three times (months 12, 18 ,24) and undergo gynecological examination and pap smear test, colposcopy and annual biopsy and in 18, 24 month undergo gynecological examination and pap smear test (in case of pap smear test suspicious) have been placed. At least two biopsy samples will be taken at the clinic. Colposcopy will be performed to evaluate the response to treatment despite the normal appearance of the cervix. Histological biopsy status of CIN 1 lesions in two control and intervention groups. Timepoint: To measure this criterion, women are visited three times (months 12, 18,24) and undergo gynecological examination and pap smear test, colposcopy and annual biopsy and in 18 undergo gynecological examination and pap smear test (in case of pap smear test suspicious) have been placed. Method of measurement: To measure this criterion, women are visited three times (months 12, 18, 24) and undergo gynecological examination and pap smear test, colposcopy and annual biopsy and in 18 undergo gynecological examination and pap smear test (in case of pap smear test suspicious) have been placed. Hamadan University of Medical Sciences Approved 2022-07-23 Ethics committee of hamadan University of Medical Sciences Fatemieh hospital, Pastaran Ave. hamadan Hamadan Iran (Islamic Republic of)