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IRCT20171030037093N31 IRCT 2020-03-05 Esfahan University of Medical Sciences Comparison of sclerotherapy and laparoscopic cystectomy on ovarian reserve and disease relapse in patients with ovarian endometriosis Evaluation and comparison of the sclerotherapy and laparoscopic cystectomy on the ovarian reserve and the disease relapse of patients with ovarian endometriosis in university hospitals, Isfahan 2020-02-20 anticipated 70 Complete https://irct.ir/trial/45563 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients in this study are randomly divided into two groups of A and B. In this way, a code is provided for each of the two intervention groups, and patients are randomly assigned to one of the two groups by choosing one of the two codes. 3 Ovarian endometriosis. Intervention 1: First intervention group: The first group will consist of 35 patients undergoing sclerotherapy with cook needle under sedation. The method of treatment for sclerotherapy is that transvaginal sclerotherapy is performed under sedation and sonography guide and if the surgeon observes endometriosis, the specimen is punctured with a special puncture needle and aspirated. Then about 80% of the volume aspirated up to a maximum of 100 ml from ethanol 95% enters the lesion.The ethanol stays in the lesion for about 20 minutes and then is completely discharged to eliminate ethanol complications. Patients will be monitored for at least 3 hours. Intervention 2: Second intervention group: the second group will include 35 patients undergoing laparoscopic cystectomy for endometrial lesions. 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 I will decide until finishing the study
public Hatav Ghasemi Tehrani
Alzahra hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3445 2031 Hatav.tehrani2014@gmail.com Esfahan University of Medical Sciences scientific Hatav Ghasemi Tehrani
Alzahra hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3445 2031 Hatav.tehrani2014@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Detection of endometriosis by ultrasound or MRI Patient Satisfaction for Inclusion Ages over 18 years No doubt to malignancy Abnormal amounts of CA125 tumor marker Having infertility Having chronic pelvic pain Ovarian cysts about 4-8 cm 18 years no limit Female Patients whose information is incomplete Non-endometriotic ovarian masses History of any malignancy N80.1 Endometriosis of ovary Treatment - Surgery Treatment - Surgery First intervention group: The first group will consist of 35 patients undergoing sclerotherapy with cook needle under sedation. The method of treatment for sclerotherapy is that transvaginal sclerotherapy is performed under sedation and sonography guide and if the surgeon observes endometriosis, the specimen is punctured with a special puncture needle and aspirated. Then about 80% of the volume aspirated up to a maximum of 100 ml from ethanol 95% enters the lesion.The ethanol stays in the lesion for about 20 minutes and then is completely discharged to eliminate ethanol complications. Patients will be monitored for at least 3 hours. Second intervention group: the second group will include 35 patients undergoing laparoscopic cystectomy for endometrial lesions. Recurrence of endometriosis lesions. Timepoint: 12 weeks after interventon. Method of measurement: Sonography. Ovarian reserve. Timepoint: 12 weeks after interventon. Method of measurement: Measurement of anti-mullerian hormoneserum levels. Esfahan University of Medical Sciences Approved 2020-01-04 Ethics Committee of Isfahan University of Medical Sciences Isfahn University of Medical Sciences, Hezar Jarib st, Isfahan Isfahan Isfehan Iran (Islamic Republic of)