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IRCT20230111057113N2 IRCT 2024-01-03 Shahid Beheshti University of Medical Sciences Examination of the second sample of ejaculated sperm in patients with high DNA fragmentation( DFI) TESE Fertilization rate comparison in IntraCytoplasmic Sperm Injection(ICSI) cycles with second ejaculated sperm sample versus(Testicular sperm extraction) TESE sample in patients with high Deoxyribonucleic acid (DNA) fragmentation index(high DFI) 2023-12-22 anticipated 30 Complete https://irct.ir/trial/69352 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients are randomly placed in one of the two study and intervention groups with the help of a random number table and receive the services related to the same group. 2 High DNA fragmentation index in sperm of infertile men. Intervention 1: Control group: TESE sample (TESE sample is prepared from patients under anesthesia). Intervention 2: Intervention group: second sample of ejaculated sperm (patients will be asked to take another sample from the first sample within one to three hours). Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: The access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: It is allowed to use the documents for the thesis with references Where to obtain: Email to this address dresmaeili@gmail.com How to obtain: After a month, they will receive the results Comments:
public samaneh esmaeili
Taleghani Hosp,Araabi st,Yaman Ave,Chamran,Tehran Highway,
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1307 dresmaeili@gmail.com Shahid Beheshti University of Medical Sciences scientific samaneh esmaeili
Taleghani Hosp,Araabi st,Yaman Ave,Chamran,Tehran Highway,
Tehran Iran (Islamic Republic of) Taleghani Hosp,Araab +98 21 2303 1307 dresmaeili@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) At least 1 failed ART(Assissted Reproductive technology) attempts women between 18 and 40 years old High DFI levels of more than 30% in semen samples at admission Men between 20and 50 years old 20 years 50 years Both A male patient with obvious abnormalities noted in the medical history, physical examination, endocrine profile, and evidence of subclinical genital infections, leukocytospermia, cryptorchidism, cancer, history of chemotherapy or radiotherapy, or severe varicocele 2- Women with a history of poor response to ovarian stimulation or meeting the POSEIDON((Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) criteria for expected poor responders Pre-implantation genetic screening (PGS), frozen/thawed embryo transfer cycles, Apparent pathology of the uterus or tube 5- People with genetic disorders 6- Male patients with heavy smoking (more than 20 cigarettes per day) 7-Severe endometriosis 8-Patients with sperm freezing N46.8 Other male infertility Treatment - Surgery Treatment - Other Control group: TESE sample (TESE sample is prepared from patients under anesthesia) Intervention group: second sample of ejaculated sperm (patients will be asked to take another sample from the first sample within one to three hours) Fertilization rate determination in ICSI (IntraCytoplasmic Sperm Injection)cycles with the second sample of ejaculated sperm in patients with high DFI(DNA Fragmentation Index). Timepoint: Checking the fertilization rate after 3 days following oocyte injection. Method of measurement: percentage (calculated by dividing the number of 2 pronuclei by the total number of injected eggs). Determining the amount of grade one and two embryos in ICSI cycles with the second sample of ejaculated sperm in patients with high DFI. Timepoint: The number of grade 1 and 2 embryos on day 3 after injection. Method of measurement: Percentage (calculated by dividing the number of grade one and two embryos by the total number of embryos formed). Determination of grade one and two embryos in ICSI cycles with TESE (Testicular Sperm Extraction)samples in patients with high DFI. Timepoint: The number of grade 1 and 2 embryos on day 3 after injection. Method of measurement: Percentage (calculated by dividing the number of grade one and two embryos by the total number of embryos formed). Fertilization rate determination in ICSI cycles with TESE-derived sperm(Testicular Sperm extraction) in patients with high DFI. Timepoint: Checking the fertilization rate after 3 days following oocyte injection. Method of measurement: percentage (calculated by dividing the number of pronuclei by the total number of injected eggs). Investigating the forward motility of sperms in the second sample of ejaculated sperm. Timepoint: The sample within one hour of the first sample. Method of measurement: The percentage of forward-moving spermatozoa to the total spermatozoa observed by light microscopy. Examination of other sperm parameters in TESE (Testicular sperm Extraction)sample. Timepoint: Sample immediately after TESE. Method of measurement: The percentage of forward-moving spermatozoa to the total spermatozoa observed by light microscopy. Examination of sperms with normal shape in the second sperm sample. Timepoint: Sample within one to three hours of the first sample. Method of measurement: The percentage of sperms with normal shape to the total sperms with a light microscope. Examination of sperms with normal shape in the sample obtained from TESE. Timepoint: Sample immediately after TESE. Method of measurement: The percentage of sperms with normal shape to the total sperms and observed with a light microscope. Examining the concentration of sperms in the second sample of ejaculated sperm. Timepoint: The sample within one hour to three after the first sample. Method of measurement: Calculate it under a light microscope and in one cc of ejaculate. Investigating the concentration of sperms in the TESE sample. Timepoint: Sample immediately after TESE. Method of measurement: Calculate it under a light microscope and in a cc of semen sample. Shahid Beheshti University of Medical Sciences Approved 2023-12-13 Ethics Committee of Shahid Beheshti University of Medical Sciences Taleghani Hosp,Araabi st,Yaman Ave,Chamran,Tehran Highway, Tehran Tehran Iran (Islamic Republic of)