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IRCT20180130038561N2 IRCT 2023-09-03 Yazd University of Medical Sciences Sperm selection by cumulus column Investigating sperm parameters, DNA integrity, embryo cytokinetic and pregnancy rate from sperms selected by cumulus column compared to the control group in male factor infertile couples. 2023-10-23 anticipated 100 Complete https://irct.ir/trial/72313 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is done individually and by statistical software, Blinding description: In this study, the patient, the clinical embryologist, and the gynecologist are considered blind. 3 Male infertility. Intervention 1: Intervention group: The sperm selected for injection have passed through the cumulus column. Intervention 2: Control group: The sperm selected for injection prepared with the density gradient method. No - There is not a plan to make this available Justification or reason for not sharing IPD is Maintaining and respecting the confidentiality of patient information
public Dr. Esmat Mangoli
Bouali Ave. Timsar Fallahi St. Yazd
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 es.mangoli@gmail.com Yazd University of Medical Sciences scientific Dr. Esmat Mangoli
Bouali Ave.Timsar Fallahi St.Yazd
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 es.mangoli@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Infertility couples with a male factor without varicocele diagnosis (at least one of the three sperm parameters outside the normal values ​​defined by WHO) and a normal woman based on regular cycles, normal hysterosalpingogram, normal vaginal ultrasound, age under 38 years Estradiol level below 3000 and the presence of at least 3 follicles with a size > 14 on the trigger day Referring to the first or second cycle(s) of ICSI Having at least 6 mature MII oocytes for ICSI Male age less than 45 years no limit 38 years Both Male patients with severe male factor according to WHO criteria Frozen sperm sample Sperm sample obtained by aspiration or extraction from the testis HIV positive patients PCOS and endometriosis patients Patients at risk of OHSS N46 Azoospermia NOS Oligospermia NOS Treatment - Other Treatment - Other Intervention group: The sperm selected for injection have passed through the cumulus column Control group: The sperm selected for injection prepared with the density gradient method Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: Beta hCG test. Differences in oocyte quality between individuals. Timepoint: The quality of oocyte is checked after puncture and before in vitro fertilization. Method of measurement: Grading based on standard criteria. Yazd University of Medical Sciences Approved 2023-06-27 Ethics committee of Shahid Sadoughi University of Medical Sciences Bouali Ave.Timsar Fallahi ST.Yazd Yazd Yazd Iran (Islamic Republic of)