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IRCT20231015059725N1 IRCT 2023-11-02 Iran University of Medical Sciences Effect of corticosteroid in improving the results of embryo transfer in patients with endometriosis Investigating the effect of corticosteroids in improving the results of embryo transfer in infertile patients with endometriosis in Akbarabadi Hospital, Tehran. 2022-03-01 anticipated 110 Complete https://irct.ir/trial/73189 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, we create a table of random numbers using a computer, then we randomly select a number from the table of real numbers for the first patient after obtaining informed consent for random allocation. For the next patients, we move one house to the right in the table of random numbers, and if the numbers are even, they will be assigned to the intervention group, and if the numbers are odd, they will be assigned to the control group, Blinding description: The blinding of the study was such that the outcome evaluator and the data analyst did not know about the content of the intervention. When prescribing the drug, the drug was given to the patient by the researcher for administration by mentioning the drug dosage and the method of administration. The outcome evaluator recorded the outcome based on the patient's identification number according to the randomization table, and the collected data was provided to the data analyst based on the number and mention of the intervention. 3 Endometriosis and infertility. Intervention 1: Intervention group: Infertile endometriosis patients and candidates for embryo transfer treated with Differlin 3.75 in three doses with an interval of one month and then 10 weeks later starting the first dose of Differlin treated with methylprednisolone 2.5 mg daily until the fetal heart is seen. In the ultrasound, the medicine is taken and then it is stopped little by little. Intervention 2: Control group: Infertile endometriosis patients and candidates for embryo transfer are treated with 3 doses of 3.75 mg Differlin ampoules every month for 3 months, and then they will undergo embryo transfer after receiving the third dose. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Azadeh Shiralizadeh
35,17 Ershad,kuye naft,Ahwaz Town
Ahwaz Iran (Islamic Republic of) 6166663437 +98 61 3627 2597 azadehshiralizadeh96@gmail.com Iran University of Medical Sciences scientific Azadeh Shiralizadeh
35,17 Ershad,kuye naft,Ahwaz Town
Ahwaz Iran (Islamic Republic of) 6166663437 +98 61 3627 2597 azadehshiralizadeh96@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 40 years Having endometriosis based on laparoscopic evidence 20 years 40 years Female presence of severe sperm disorders in the patient's wife based on WHO 2021 criteria congenital or acquired uterine anomalies in the patient Suffering from thrombophilic diseases such as hemophilia Suffering from autoimmune diseases such as lupus The use of hormonal treatments by the individual Taking immunosuppressant drugs by the individual Treatment - Drugs Treatment - Drugs Intervention group: Infertile endometriosis patients and candidates for embryo transfer treated with Differlin 3.75 in three doses with an interval of one month and then 10 weeks later starting the first dose of Differlin treated with methylprednisolone 2.5 mg daily until the fetal heart is seen. In the ultrasound, the medicine is taken and then it is stopped little by little. Control group: Infertile endometriosis patients and candidates for embryo transfer are treated with 3 doses of 3.75 mg Differlin ampoules every month for 3 months, and then they will undergo embryo transfer after receiving the third dose. Chemical pregnancy. Timepoint: Pregnancy check with beta hCG test two weeks after embryo transfer. Method of measurement: Beta hCG test. Abortion. Timepoint: Continued pregnancy up to 20 weeks. Method of measurement: Examining the view of a live fetus with ultrasound. Live birth. Timepoint: Pregnancy with a gestational age of more than 28 weeks. Method of measurement: Examining the live fetus with ultrasound. Clinical pregnancy. Timepoint: Sonography 6 weeks later beta hCG positive. Method of measurement: Visualization of fetal heart rate by ultrasound. Ongoing pregnancy. Timepoint: Continued pregnancy up to 12 weeks. Method of measurement: Ultrasound visualization of a live fetus at 12 weeks. Vice President of Research and Technology of Iran University of Medical Sciences Approved 2021-10-07 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)