Male Infertility. Male infertility
Conditions
Interventions
Intervention 1: Intervention group: Sperm selection is performed using a centrifuge-free "Synergistic Biomimetic" method. This system involves creating interconnected droplets with medium bridges, uti
Sponsors
Yazd University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Couples with primary male factor infertility (according to WHO 2021 criteria) Female age between 18 and 38 years Male age between 20 and 45 years Female Body Mass Index (BMI) between 18 and 30 kg/m^2 Candidates for ICSI cycle with at least 4 Metaphase II (MII) oocytes retrieved
Exclusion criteria
Exclusion criteria: History of more than 3 failed previous ART cycles Current use of cytotoxic drugs (chemotherapy) or steroids Presence of systemic diseases (e.g., uncontrolled diabetes, malignancies) Severe female factor infertility (e.g., Endometriosis stage III-IV, uncontrolled PCOS) History of varicocelectomy, untreated varicocele, or genetic abnormalities (e.g., Klinefelter syndrome) Active urogenital infections (e.g., UTI) or Sexually Transmitted Diseases (STDs) in either partner Diagnosis of Azoospermia or Cryptozoospermia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy. Timepoint: the observation of gestational sac and fetal heartbeat at 6-8 weeks. Method of measurement: ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| Chemical pregnancy rates. Timepoint: 14 days post-transfer. Method of measurement: Serum Beta-hCG titration.;Implantation rate. Timepoint: week 6 (implantation). Method of measurement: Ultrasound.;Embryo morphokinetic parameters. Timepoint: Days 1, 3, and 5 post-fertilization. Method of measurement: Assessment via Time-lapse system and Gardner scoring system.;Blastocyst formation rates. Timepoint: 5 days after fertilization. Method of measurement: Assessment via Time-lapse system and Gardner scoring system.;Cleavage rates. Timepoint: 3 days after fertilization. Method of measurement: Assessment via Time-lapse system and Gardner scoring system.;Fertilization rate (2PN formation rate). Timepoint: 16 to 18 hours after microinjection (ICSI). Method of measurement: Microscopic evaluation.;Percentage of progressive sperm motility. Timepoint: Immediately after sample preparation and prior to injection. Method of measurement: Microscopic evaluation according to WHO 2021 criteria.;Percentage of sperm with normal morphology. Timepoint: Immediately after sample preparation and prior to injection. Method of measurement: Staining and evaluation according to WHO 2021 criteria.;Sperm DNA Fragmentation Index (DFI). Timepoint: Immediately after sample preparation and prior to injection. Method of measurement: Using Sperm Chromatin Dispersion (SCD) test.;Percentage of cleavage anomalies and embryo fragmentation rate. Timepoint: Embryonic day 3. Method of measurement: Assessment via Time-lapse system and Gardner scoring system.;Blastocyst quality. Timepoint: Embryonic day 5. Method of measurement: Assessment of Inner Cell Mass (ICM) and Trophectoderm according to Gardner criteria using Time-lapse system. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzam Lotfalian
Yazd University of Medical Sciences
Outcome results
None listed