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Study aim
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Comparison of the fertilization rate and the amount of good quality embryos (grade one and two) in couples who could undergo ICSI(Intracytoplamic sperm Injection), either using TESE(Testicular Sperm Extraction) or second sperm in male subjects with high DFI (DNA Fragmentation Index)and previous ART(Assisted ReproductiveTechnology) failure.
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Design
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Clinical trial with control group, with parallel groups, randomized, phase 2 on 30 patients. Patients are randomly assigned to one of the study and intervention groups with the help of a random number table and receive the services of the same group.
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Settings and conduct
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The number of 30 couples referred to Taleghani Hospital with a history of infertility who are candidates for ICSI are examined in the form of intervention
and control groups of15 people.
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Participants/Inclusion and exclusion criteria
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There are couples who have had a history of at least 1 failure in the previous ART (Assisted Reproductive Technology)and in semen analysis, normosospermic men with DFI >30%(DNA Fragmentation Idex)
Men are between 20 and 50 years old with normal semen Analysis, and women are between 18 and 40 years old. The cause of infertility in all patients is diagnosed only as a male factor
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Intervention groups
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30infertile couples candidates for ICSI, divided to 2 groups of 15 patients (1:intervention: from the normosospermic patients with high DFI within 1 to 3 hours of the first sample, the second sperm sample will be taken) and The control group (under anesthesia during the TESE process, a biopsy will be taken from the testicular tissue and the sperm will be extracted in the laboratory) are examined.
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Main outcome variables
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Two groups will be examined and compared in terms of ICSI outcomes, including fertilization rate, the amount of good quality embryos (G1 and G2) and some sperm parameters (concentration, forward movement, normal shape)