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IRCT20180409039247N6 IRCT 2023-05-30 Tehran University of Medical Sciences A randomized clinical trial comparing the effect of intraovarian and subcutaneous injection of corifollitropin alfa in the Duostim protocol in infertile women with premature ovarian failure and poor responders candidates for IVF A randomized clinical trial comparing the effect of intraovarian and subcutaneous injection of corifollitropin alfa in the Duostim protocol in infertile women with premature ovarian failure and poor responders candidates for IVF 2023-06-22 anticipated 30 Complete https://irct.ir/trial/70048 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: One list of computerized randomization is created by an analyst who is blind to the trial. All participants are blind either. randomization is by blocking by WWW.Sealedenvelop.com by the epidemiologist. The blocks are size 6. : AAAABBBB-AAABBBBA-AAABBBAB-AAABBAABB-AABBBBAA-AABBAABB-AABBBAAB intervention group: intraovarian injection and control group: routine treatment (subcutaneous injection). N/A infertility. Intervention 1: Intervention group: Dostim protocol is performed as an intraovarian injection but with CORIFOLLITROPIN ALFA (elonva) instead of rFSH on the day of egg retrieval in the operating room, and then the routine cycle of Dostim continues. Intervention 2: Control group: Dustim protocol is administered as a subcutaneous injection but with CORIFOLLITROPIN ALFA (elonva) instead of rFSH on the day of egg retrieval in the operating room, and then the Dostim routine cycle continues. 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 There is no further information
public Firoozeh Rakhshani
East Bagherkhan, Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 0000 dr.frakhshanim@gmail.com Tehran University of Medical Sciences scientific Firoozeh Rakhshani
East Bagherkhan, Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 0000 dr.frakhshanim@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) BMI<= ۳۰ Poor responder cases with abnormal biomarkers AFC :۵_۷،AMH <۰.۵-۱.۱) History of non-response in previous cycles (less than 3 oocytes) or first ivf experience Sperm analysis is normal or has the minimum necessary criteria for ICSI 32 years 42 years Female History of autoimmune diseases - coagulation disorders - uterine anomalies - chromosomal and genetic disorders - chronic renal and metabolic diseases - hypo and hyperthyroidism - history of malignancy - endometriosis - history of repeated miscarriage and RIF N97 Female infertility Treatment - Drugs Treatment - Drugs Intervention group: Dostim protocol is performed as an intraovarian injection but with CORIFOLLITROPIN ALFA (elonva) instead of rFSH on the day of egg retrieval in the operating room, and then the routine cycle of Dostim continues. Control group: Dustim protocol is administered as a subcutaneous injection but with CORIFOLLITROPIN ALFA (elonva) instead of rFSH on the day of egg retrieval in the operating room, and then the Dostim routine cycle continues. The number and quality of oocytes obtained. Timepoint: On the day of puncture. Method of measurement: The number of eggs obtained on the day of puncture with OPU catheter. Number and quality of obtained embryos. Timepoint: The day after the puncture in the embryology laboratory. Method of measurement: Under the microscope in the embryology laboratory by the embryologist. Tehran University of Medical Sciences Approved 2023-03-15 Ethics committee in the research of Imam Khomeini hospital complex Imam complex, East Bagherkhan street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)