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IRCT20110804007223N11 IRCT 2022-06-09 Royan Institute Comparison of clinical outcomes between two sperm separation procedures: Felix vs. DGC Comparison of clinical outcomes of infertile men candidate for ICSI between two methods of sperm separation: Felix device based on surface electric charge and density gradient centrifugation (DGC) 2022-06-01 anticipated 100 Complete https://irct.ir/trial/62636 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The individual performing ICSI will be blinded to the methods of sperm processing (group one: density gradient centrifuge (DGC) method and group two: electric charge using a flex device method) and also the allocation of oocytes to each group. N/A Sperm selection procedure. Intervention 1: For each semen sample, two procedures will be carried out for sperm preparation. One of the procedures (Control) will be used for half of the sibling oocytes, and another procedure (study) will be used for other sibling oocytes. Study (Flix) group: For each sample, one Felix cartridge will be used. 1ml of liquefied semen sample will be transferred to Felix SYSTEM. Each cartridge contains two chambers:1. Harvest chamber – 1ml of G-IVF Plus (Vitrolife; Sweden).2. Reservoir chambers (2) – 4mls of G-Rinse (Vitrolife; Sweden) in each (8mls total). The selected sperm will then be collected from the harvest chamber based on the electric charge, and the sperm wash medium (VitaSperm: Innovative Biotech, Iran) in addition to 10% human serum albumin will be added. Intervention 2: Control (DGC) group: 1ml of 40% PureSperm gradient (Vitrolife; Sweden) will be transferred on 1ml of 80% PureSperm gradient (Vitrolife; Sweden) into a conical centrifuge tube. Then, 1ml of liquefied semen sample will be placed on the top of the upper layer, and the tube Will be centrifuged for 20 min at 1000rpm. The upper and lower layers will carefully be aspirated without disturbing the pellet. VitaSperm washing media (Innovative Biotech, Iran) + 10% human serum albumin will be then added to the pellet. Adjust sperm concentration DGC similar to sperm concentration Felix in the same volume. 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 Considering the the Felix instrument and its cartridge's are provide by Memphasys company in Australia, data can be published following their agreement
public Mohammad Hossein Nasr-Esfahani
Salman St; Royan St
Isfahan Iran (Islamic Republic of) 8159358686 +98 31 9501 5682 nasr.royan@gmail.com Royan Institute scientific Mohammad Hossein Nasr-Esfahani
Salman St; Royan St
Isfahan Iran (Islamic Republic of) 8159358686 +98 31 9501 5682 nasr.royan@gmail.com Royan Institute Iran (Islamic Republic of) Couples candidate for ICSI The number of follicles: at least 10 MII oocytes. Infertile couples with male factor infertility (sperm parameters lower than defined threshold by WHO 2021) Female age ≤ 38 years Men with at least 2ml semen Embryo transfer only at blastocyst stage One blastocyst for transfer Normal female (female will be considered as normal if they have a regular cycle with patent tube and absence of endometriosis ) Men with a total sperm cell count higher than 5 million per ejaculate 15 years 38 years Female Men with testicular sperm extraction or epididymal sperm aspiration Men with cryo-preserved semen samples N46 Male infertility Treatment - Devices Treatment - Devices For each semen sample, two procedures will be carried out for sperm preparation. One of the procedures (Control) will be used for half of the sibling oocytes, and another procedure (study) will be used for other sibling oocytes. Study (Flix) group: For each sample, one Felix cartridge will be used. 1ml of liquefied semen sample will be transferred to Felix SYSTEM. Each cartridge contains two chambers:1. Harvest chamber – 1ml of G-IVF Plus (Vitrolife; Sweden).2. Reservoir chambers (2) – 4mls of G-Rinse (Vitrolife; Sweden) in each (8mls total). The selected sperm will then be collected from the harvest chamber based on the electric charge, and the sperm wash medium (VitaSperm: Innovative Biotech, Iran) in addition to 10% human serum albumin will be added. Control (DGC) group: 1ml of 40% PureSperm gradient (Vitrolife; Sweden) will be transferred on 1ml of 80% PureSperm gradient (Vitrolife; Sweden) into a conical centrifuge tube. Then, 1ml of liquefied semen sample will be placed on the top of the upper layer, and the tube Will be centrifuged for 20 min at 1000rpm. The upper and lower layers will carefully be aspirated without disturbing the pellet. VitaSperm washing media (Innovative Biotech, Iran) + 10% human serum albumin will be then added to the pellet. Adjust sperm concentration DGC similar to sperm concentration Felix in the same volume. Blastocysts rate and quality. Timepoint: Day 5 or 6 after ICSI. Method of measurement: Microscope. Fertilization. Timepoint: 16-18 hours after ICSI. Method of measurement: The number of 2PNs divided by the number of MII oocytes injected by ICSI multiplied by 100. Embryo quality. Timepoint: 2 or 3 day after ICSI. Method of measurement: According to DK Gardner criteria (2016). Biochemical pregnancy. Timepoint: Post implantation. Method of measurement: Beta hCG level. Clinical pregnancy. Timepoint: Fifth or sixth week of pregnancy. Method of measurement: The observation of a fetal sacs and also fetal heartbeat by sonography. Implantation. Timepoint: One to two weeks after blastocyst transfer. Method of measurement: Sonography. Livebirth. Timepoint: At the time of delivery. Method of measurement: By phone call. Royan Institute Approved 2020-12-22 Royan Institute Banihashem Tehran Tehran Iran (Islamic Republic of)