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IRCT20191206045629N1 IRCT 2020-05-06 Tehran University of Medical Sciences Efficacy of aspiration and Ethanol sclerotherapy in primary and recurrent endometrioma on IVF outcome Efficacy of aspiration and Ethanol sclerotherapy in primary and recurrent endometrioma on IVF outcome 2020-04-18 anticipated 80 Complete https://irct.ir/trial/44142 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients will be informed of the possibility of a new intervention to increase the likelihood of fertility, but no information will be given on which of the patients will be given this operation. Due to the fact that therapists were unaware of the possible intervention, blinding was performed. Double-blinding was not feasible in this study. N/A Ovarian endometrioma. Intervention 1: Intervention group: 2 to 3 days after the termination of menstruation, in the operating room under conscious sedation and in the lithotomy position, under the ultrasound guidance, ovarian cyst content is aspirated. afterward, 80% of the aspirated volume of cyst is substituted by 98% ethanol for 15 minutes and then aspirated. Intervention 2: Control group: Intervention group: 2 to 3 days after the termination of menstruation, in the operating room under conscious sedation and in the lithotomy position, under the ultrasound guidance, ovarian cyst content is aspirated. afterward, 80% of the aspirated volume of cyst is substituted by Normal saline for 15 minutes and then aspirated. 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 no further information
public Leila shahsavari
saadat abad, bulvard 24 meter, dashte behesh, between 4th and 5th street#6 first floor
Tehran Iran (Islamic Republic of) 1998683611 +98 21 2206 8580 shahsavari_l@yahoo.com Tehran University of Medical Sciences scientific ashraf aleyasin
north kargar street, jalal al ahmad avenue,shariati hospital
tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 alyasina@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) all infertile women in shariati hospital, in 20-40 year age interval with primary or recurrent endometrioma 20 years 40 years Female having or history of hepatic having or history of renal having or history of cardiac diseases having or history of any endometrioma larger than 10 cm and smaller than 3 cm having or history of any cyst with thickened wall suspicious for malignancy N80.1 Endometriosis of ovary Treatment - Surgery Treatment - Surgery Intervention group: 2 to 3 days after the termination of menstruation, in the operating room under conscious sedation and in the lithotomy position, under the ultrasound guidance, ovarian cyst content is aspirated. afterward, 80% of the aspirated volume of cyst is substituted by 98% ethanol for 15 minutes and then aspirated. Control group: Intervention group: 2 to 3 days after the termination of menstruation, in the operating room under conscious sedation and in the lithotomy position, under the ultrasound guidance, ovarian cyst content is aspirated. afterward, 80% of the aspirated volume of cyst is substituted by Normal saline for 15 minutes and then aspirated. Fertility rate/ Pregnancy Rate. Timepoint: at the end of study. Method of measurement: observation of fetal heart activity by ultrasound. Tehran University of Medical Sciences Approved 2019-04-16 ethics committee of tehran university of medical sciences Tehran-saadat abad- bulvard 24 meter- dasht behesh- between 4th and 5th west street#6 frist floor Tehran Tehran Iran (Islamic Republic of)