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IRCT20110804007223N9 IRCT 2019-10-17 Royan Institute Comparison of clinical outcomes in two sperm selection procedures: capillary – cumulus oophorus versus routine method Comparison of clinical outcomes of infertile individuals candidate for ICSI using capillary–cumulus oophorus model versus routine method: A randomized single-blind controlled clinical trial 2019-09-06 anticipated 40 Complete https://irct.ir/trial/41979 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The embryologist is completely unaware of the methods of sperm preparation (the routine method or the method of the passage of sperm from the cumulus oophorus layer), and the spermatozoa are given to the embryologist within the tubes containing the code. Therefore, the embryologist only selects sperm based on the morphology and motility in both groups and injects sperm into the oocyte. In the following days, the embryologist checks the fertilization rate, and the quality of the embryo, without knowing what kind of sperm preparation procedures is used. N/A Male infertility. Intervention 1: Intervention group: Sperm selection after passing sperm through the cumulus oophorus layer (The cumulus oophorus is a layer around the oocyte which will be separated from the oocyte of the patient's wife in vitro and placed in a capillary tube. From one end of the tube, sperm enter. After one hour, the sperms that have passed through the cumulus oophorus will be separated and injected into the oocyte.). Intervention 2: Control group: Sperm routine selection based on morphology and viability. 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 more information.
public Mohammad Hossein Nasr-Esfahani
Royan Institute for Biotechnology, Royan St, Salman St, Khorasgan squ, Jey St.
Esfahan Iran (Islamic Republic of) 8159358686 +98 31 9501 5682 nasr.royan@gmail.com Iranian academic center for education culture and research scientific Mohammad Hossein Nasr-Esfahani
Royan St, Salman St, Khorasgan squ, Jey St.
Esfahan Iran (Islamic Republic of) 8159358686 +98 31 9501 5682 nasr.royan@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) Infertility with male factor primary infertility Candidate for ICSI Healthy women with at least 6 oocytes Male age lower than 45 year no limit 45 years Male Infertile men with azoospermia Infertile men with oligozoospermia defrosted sperm N46.9 Male infertility, unspecified Other Other Intervention group: Sperm selection after passing sperm through the cumulus oophorus layer (The cumulus oophorus is a layer around the oocyte which will be separated from the oocyte of the patient's wife in vitro and placed in a capillary tube. From one end of the tube, sperm enter. After one hour, the sperms that have passed through the cumulus oophorus will be separated and injected into the oocyte.) Control group: Sperm routine selection based on morphology and viability Improvement of embryo quality. Timepoint: Day 2 and 3 after ICSI. Method of measurement: Embryo growth, number and equal of blastomers, and lack of cytoplasm fragmentation. Pregnancy. Timepoint: One month after embryo transfer. Method of measurement: Sonography. Royan Institute Approved 2019-07-17 Ethics committee of Royan Institute Royan Institute, Hafez St, Banihashem Ave, Resalat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)