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IRCT20200825048515N26 IRCT 2021-03-30 Esfahan University of Medical Sciences Comparison of ovarian reserve in laparoscopic endometrioma surgery with and without vasopressin injection Comparison of ovarian reserve in laparoscopic endometrioma surgery with and without vasopressin injection 2021-03-21 anticipated 44 Complete https://irct.ir/trial/55094 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: En In this study, 44 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups, Blinding description: In this study, vasopressin and placebo are pre-prepared and placed in coded packages, and delivered daily to the relevant specialist. She prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. 3 Ovarian endometrioma. Intervention 1: Intervention group: In this group, 20 units of diluted vasopressin (Elixir Pharmaceutical Company) will be diluted by 200 times (0.1 units per ml) during surgery. 3 ml of diluted vasopressin will be injected at one to three points near the great vessels, with the exception of the area of the ovarian hilus, and between the cyst space and the ovarian parenchyma, so that 0.3 units of vasopressin will be used for each patient. The mentioned injection will be followed by 30-40 ml of normal saline will be injected into the ovaries in different spaces for the hydro dissection and the prevention of vasopressin complications including arrhythmias. Intervention 2: Control group: In this group, first 3 ml of normal saline will be injected in one to three points similar to those of the intervention group, and then another 30-40 ml of normal saline will be injected into the ovarian space completely similar to that of the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Safoura Rouholamin
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 s_rouholamin@med.mui.ac.ir Esfahan University of Medical Sciences scientific Safoura Rouholamin
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 s_rouholamin@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of unilateral ovarian endometrioma by ultrasound The size of the cyst should be between 30 and 70 mm Lack of the evidence of ovarian cancer Normal menstrual cycle Individuals with symptomatic endometrioma and surgical indications (infertility, failed assistedreproductive technology (ART) treatment cycles, pelvic pain) no limit no limit Female Patient’s pregnancy Body mass index above 30 kg/m² History of any malignancy Detection of ovarian cysts other than endometrioma after surgery Atypical endometrioma History of kidney, liver, and heart diseases (hypertension - cardiac arrhythmia - ischemia) Use of combined contraceptive pills before surgery (over the last three months) Previous surgery of endometrioma Polycystic ovary syndrome N80.1 Endometriosis of ovary Treatment - Surgery Treatment - Surgery Intervention group: In this group, 20 units of diluted vasopressin (Elixir Pharmaceutical Company) will be diluted by 200 times (0.1 units per ml) during surgery. 3 ml of diluted vasopressin will be injected at one to three points near the great vessels, with the exception of the area of the ovarian hilus, and between the cyst space and the ovarian parenchyma, so that 0.3 units of vasopressin will be used for each patient. The mentioned injection will be followed by 30-40 ml of normal saline will be injected into the ovaries in different spaces for the hydro dissection and the prevention of vasopressin complications including arrhythmias. Control group: In this group, first 3 ml of normal saline will be injected in one to three points similar to those of the intervention group, and then another 30-40 ml of normal saline will be injected into the ovarian space completely similar to that of the intervention group. Number of antral ovarian follicles. Timepoint: Before and three months after surgery. Method of measurement: Transvaginal ultrasound. Serum levels of anti mullerian hormone. Timepoint: Before and three months after surgery. Method of measurement: Kit made by Biomeriux company. Isfahan University of Medical Sciences Approved 2021-02-15 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)