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IRCT201504307223N3 IRCT 2015-10-11 Royan Institute Comparison of clinical outcomes in tow sperm selection procedure Comparison of clinical outcomes in two sperm selection procedures (density gradient centrifugation with surface markers- density gradient centrifugation) in infertile men intra-cytoplasmic sperm injection candidate 2014-01-28 anticipated 50 Complete https://irct.ir/trial/7656 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research. N/A Male factor infertility. Intervention 1: Intervention group: Half of oocytes were inseminated with sperm that selected with DGC following MACS processing (Separate intact spermatozoa from those that present apoptotic markers by magnetic particles conjugated with Annexin V, which has a high affinity for Phosphatidylserine)(MACS-DGC group). Intervention 2: Internal control group: Remaining oocytes were inseminated with sperm that selected with DGC method (based on viability and morphology) (DGC group). Intervention 3: External control group: َAll the oocytes were inseminated by sperm that selected with DGC method.
public Mohammad Hossein Nasr-Esfahani
Royan St, Salman St, KHorasgan, Isfahan, Iran, Royan Institute for Biotechnology
Isfahan Iran (Islamic Republic of) +98 31 9501 5688 mh_nasr@med.mui.ac.ir Royan Institute (Royan Institute for Biotechnology) scientific Mohammad Hossein Nasr-Esfahani
Royan St, Salman St, KHorasgan, Isfahan, Iran, Royan Institute for Biotechnology
Isfahan Iran (Islamic Republic of) +98 31 9501 5688 mh_nasr@med.mui.ac.ir Royan Institute (Royan Institute for Biotechnology) Iran (Islamic Republic of) Inclusion criteria: Primary male factor infertility (at least, two of their semen parameters were considered as abnormal according to the WHO-2010) Exclusion criteria: Females factor infertility basely WHO criteria (2010) with higher than 35 years and less than 6 oocytes 20 years 45 years Both N46 Male infertility Other Other Other Intervention group: Half of oocytes were inseminated with sperm that selected with DGC following MACS processing (Separate intact spermatozoa from those that present apoptotic markers by magnetic particles conjugated with Annexin V, which has a high affinity for Phosphatidylserine)(MACS-DGC group). Internal control group: Remaining oocytes were inseminated with sperm that selected with DGC method (based on viability and morphology) (DGC group) External control group: َAll the oocytes were inseminated by sperm that selected with DGC method Sperm motility. Timepoint: In daye of ICSI procedure. Method of measurement: Using optical microscope, based WHO criteria. Sperm concentration. Timepoint: In daye of ICSI procedure. Method of measurement: Using optical microscope, based WHO criteria. Sperm morphology. Timepoint: In daye of ICSI procedure. Method of measurement: Using optical microscope, based WHO criteria. Fertilization rate. Timepoint: 24 hours after ICSI procedure. Method of measurement: View of 2 pronucleuse with invert microscp. Chemical pregnancy. Timepoint: 18 days after ICSI procedure. Method of measurement: Measurement of Beta HCG level in serum. Quality of embryo. Timepoint: Three days post-oocyte retrieval. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size. Clinical l pregnancy. Timepoint: 12 weeks after ICSI procedure. Method of measurement: Fetal heart beat. Royan Institute Approved 2014-08-02 Ethic Commitee of Royan Institue Hafez St, Banihashem St, Resalat Ave, Tehran, Iran, Royan Institute Tehran Iran (Islamic Republic of)