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IRCT20200316046789N1 IRCT 2022-02-11 Esfahan University of Medical Sciences Evaluation of the effectiveness of platelet-rich plasma in the treatment of Asherman's syndrome Comparison of the effectiveness of hormone therapy alone with hormone therapy and platelet-rich plasma in the improvement of Asherman's syndrome after hysteroscopy in educational centers of Isfahan University of Medical Sciences 2020-03-20 anticipated 60 Complete https://irct.ir/trial/47965 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After definitive diagnosis and informed consent, patients are divided into two groups based on the time of referral. The selection of patients in two groups is completely random. N/A Asherman syndrome. Intervention 1: Intervention group:case (PRP and hormone therapy group) (n = 30/each groups). The selection of patients in two groups was completely random. 8.5 ml of peripheral venous blood of patient was taken through a syringe containing 1.5 ml of citrate acid. It was then centrifuged immediately at 1000 g for 10 min. The buffy coat layer and the plasma layer were collected and transferred to another tube to be centrifuged again at 3500 g for 5 min. 1.5 ml of PRP with a good concentration were finally obtained.To perform the plan for patients in the case group, after removal of the adhesion by hysteroscopy, PRP 1ml is injected into the uterine cavity wall . They are then given hormone therapy, the usual regimen is 2.5 mg of conjugatedestrogen once a day for four weeks.A progestin such as medroxyprogesterone acetate at a dose of 10 mg is added to the treatment in the last week.Finally,6 to 8 weeks later patients in both groups were examined hysteroscopically. The intrauterine adhesion grade and menstruation pattern before and after the intervention were evaluated. Intervention 2: Control group: control (hormone therapy)(n = 30/each groups) In the control group, after hysteroscopy and removal of adhesions, they are treated only with hormone therapy. They are then given hormone therapy, the usual regimen is 2.5 mg of conjugatedestrogen once a day for four weeks.A progestin such as medroxyprogesterone acetate at a dose of 10 mg is added to the treatment in the last week. Finally,6 to 8 weeks later patients in both groups were examined hysteroscopically. The intrauterine adhesion grade and menstruation pattern before and after the intervention were evaluated. Yes - There is a plan to make this available What will be shared: All data can be shared after people have not been identified When: Start of access period from 1399 To whom: Researchers working in academic institutions Conditions: For future researches Where to obtain: 09133057797 Dr. Zahra Derakhshandeh How to obtain: Contact the project executor Send documents Receive data Comments:
public Zahra Derakhshandeh
Isfahan University of Medical Sciences, Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3370 Zderakhshandeh2020@gmail.com Esfahan University of Medical Sciences scientific Zahra Derakhshandeh
Isfahan University of Medical Sciences, Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3370 Zderakhshandeh2020@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of Asherman's syndrome Age: 18 to 43 years old Informed consent to participate in the study 18 years 43 years Female Simultaneous infection of the uterus and vagina Hemoglobin less than 11 Platelet less than 150,000 History of anticoagulant use Dissatisfaction with entering the study N85.6 Intrauterine synechiae Treatment - Drugs Treatment - Drugs Intervention group:case (PRP and hormone therapy group) (n = 30/each groups). The selection of patients in two groups was completely random. 8.5 ml of peripheral venous blood of patient was taken through a syringe containing 1.5 ml of citrate acid. It was then centrifuged immediately at 1000 g for 10 min. The buffy coat layer and the plasma layer were collected and transferred to another tube to be centrifuged again at 3500 g for 5 min. 1.5 ml of PRP with a good concentration were finally obtained.To perform the plan for patients in the case group, after removal of the adhesion by hysteroscopy, PRP 1ml is injected into the uterine cavity wall . They are then given hormone therapy, the usual regimen is 2.5 mg of conjugatedestrogen once a day for four weeks.A progestin such as medroxyprogesterone acetate at a dose of 10 mg is added to the treatment in the last week.Finally,6 to 8 weeks later patients in both groups were examined hysteroscopically. The intrauterine adhesion grade and menstruation pattern before and after the intervention were evaluated. Control group: control (hormone therapy)(n = 30/each groups) In the control group, after hysteroscopy and removal of adhesions, they are treated only with hormone therapy. They are then given hormone therapy, the usual regimen is 2.5 mg of conjugatedestrogen once a day for four weeks.A progestin such as medroxyprogesterone acetate at a dose of 10 mg is added to the treatment in the last week. Finally,6 to 8 weeks later patients in both groups were examined hysteroscopically. The intrauterine adhesion grade and menstruation pattern before and after the intervention were evaluated. Uterine adhesion grade. Timepoint: 6 to 8 weeks later hysteroscopy. Method of measurement: Histroscopy. Esfahan University of Medical Sciences Approved 2020-03-09 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)