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Examination of the second sample of ejaculated sperm in patients with high DNA fragmentation( DFI)

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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230111057113N2
Enrollment
30
Registered
2024-01-03
Start date
2023-12-22
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High DNA fragmentation index in sperm of infertile men. Other male infertility

Interventions

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 ta

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactsamaneh esmaeili

Shahid Beheshti University of Medical Sciences

dresmaeili@gmail.com+98 21 2303 1307

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026