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IRCT20110530006640N4 IRCT 2018-04-16 Tehran University of Medical Sciences Comparison of the effect of OCP alone and in combination with N-acetylcysteine on clinical and ultrasound signs of endometrioma Evaluation of the recurrence of dysmenorrhea,chronic pelvic pain and sonographic symptoms of endometrioma after laparoscopic surgery in the OCP alone treated group compared with the OCP plus N-acetylcysteine group 2017-02-28 anticipated 112 Complete https://irct.ir/trial/30337 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sample size is 112 , with 56 people in each group. Block randomization method was designed by the group's epidemiologist using Stata version 13 software. The size of blocks considered is 6, Blinding description: The random allocation list for patients is solely available to the epidemiologist. To hide the random allocation process, 112 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. On each 10-digit random code packet, the order is written and the framework is written that the patient identification number is relevant and the methodologist will simply be aware of the design of the code. When the physician announces the eligibility of a patient, the methodologist will provide the envelope. The person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used. N/A Ovarian endometrioma. Intervention 1: Group 1: The first group will receive N-acetylcysteine 600 mg, three times a day, in 3 days a week for three months with continuous OCP for 6 months. Intervention 2: Group 2: The second group will continuously receive OCP alone for 6 months without the N-acetylcysteine. 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 It has not yet been decided by research team
public Dr Zahra Asgari
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 8755 asgariza@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr Zahra Asgari
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 8755 asgariza@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) being single Not having a tendency to pregnancy Diagnosis of ovarian endometrioma by ultrasound and confirmation by laparoscopic surgery no limit no limit Female Patients who are planning a pregnancy after laparoscopic surgery N80.1 Endometriosis of ovary Treatment - Drugs Treatment - Drugs Group 1: The first group will receive N-acetylcysteine 600 mg, three times a day, in 3 days a week for three months with continuous OCP for 6 months. Group 2: The second group will continuously receive OCP alone for 6 months without the N-acetylcysteine. Ultrasound recurrence of endometrioma. Timepoint: Once before surgery and once 3 months after surgery and once at the end of the study (6 months after surgery). Method of measurement: Transvaginal ultrasonically assessment of the ovaries. Dysmenorrhea recurrence. Timepoint: Once before surgery and once 3 months after surgery and once at the end of the study (6 months after surgery). Method of measurement: Visual Analog Scale (VAS). Pelvic Pain Recurrence. Timepoint: Once before surgery and once 3 months after surgery and once at the end of the study (6 months after surgery). Method of measurement: Visual Analog Scale (VAS). Tehran University of Medical Sciences Approved 2017-02-18 Ethics committee of Tehran University of Medical Sciences Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)