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IRCT201510207223N6 IRCT 2015-10-30 Royan Institute Study of Condensyl supplementary on sperm function and clinical outcome in assisted reproduction technologies resistant couples Study of Condensyl supplementary on sperm parameters, chromatin structure, fertilization rate and embryo quality in assisted reproduction technologies resistant couples 2015-11-26 anticipated 100 Complete https://irct.ir/trial/7658 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Male factor infertility. Intervention 1: Intervention group: Male participants are administrated 1 or 2 Condensyl™ tablets per day for 3 to 6 months prior to current ART cycle. Sperm parameters, DNA fragmentation and decondensation are compared before and after the Condensyl™ treatment. Combination (Condensyl™) contained of opuntia fig fruits (100 mg) delivering tailored amounts of quercetin (0.05 mg) and betalain (0.001 mg) plus a mix of Group B vitamins: B2 (1.4 mg), B3 (16 mg), B6 (1.4 mg), B9 (400 μg), B12 (2.5 μg). The administered product also contained zinc (12.5 mg) and small doses of N-acetylcysteine (250 mg) and vitamin E (12 mg). Intervention 2: Control group: Failed previous ART cycles of participated infertile men.
public Mohammad Hossein Nasr-Esfahani
Royan Institute for Biotechnology ,Royan St, Salman St, Khorasgan, Isfahan, Iran,
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 Institute for Biotechnology ,Royan St, Salman St, Khorasgan, Isfahan, Iran,
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 (according to the WHO-2010) and either a DFI (DNA Fragmentation Index) and SDI (Sperm Decondensation Index) higher than 10%. Exclusion criteria: Females factor infertility, female with higher than 40 years, less than 6 matured MII oocytes and thick endometrium. 20 years 40 years Both N46 Male infertility Treatment - Drugs Treatment - Other Intervention group: Male participants are administrated 1 or 2 Condensyl™ tablets per day for 3 to 6 months prior to current ART cycle. Sperm parameters, DNA fragmentation and decondensation are compared before and after the Condensyl™ treatment. Combination (Condensyl™) contained of opuntia fig fruits (100 mg) delivering tailored amounts of quercetin (0.05 mg) and betalain (0.001 mg) plus a mix of Group B vitamins: B2 (1.4 mg), B3 (16 mg), B6 (1.4 mg), B9 (400 μg), B12 (2.5 μg). The administered product also contained zinc (12.5 mg) and small doses of N-acetylcysteine (250 mg) and vitamin E (12 mg). Control group: Failed previous ART cycles of participated infertile men. Sperm concentration. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria. Sperm motility. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria. Sperm morphology. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria. Sperm decondensation. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope. DNA fragmentation. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Fluorescent microscope. Fertilization rate. Timepoint: 16 - 20 h after insemination/injection. Method of measurement: View of two pronuclei with invert microscope. Quality of embryo. Timepoint: Three days after insemination/injection. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size. Royan Institute Approved 2015-10-05 Ethic Committee of Royan Institute Royan Institute ,Hafez St, Banihashem St, Resalat Ave, Tehran, Iran, Tehran Iran (Islamic Republic of)