Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
202
Standard sperm preparation
Multi-step sperm preparation
IFER
Buenos Aires, Buenos Aires F.D., Argentina
Pregna
Buenos Aires, Buenos Aires F.D., Argentina
Euploidy Rate
Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle.
Time frame: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).
Clinical Pregnancy Rate
Proportion of subjects with a clinical pregnancy, defined as the presence of an intrauterine gestational sac detected by ultrasound.
Time frame: 5-7 weeks of gestation following embryo transfer.
Fertilization Rate
Proportion of oocytes successfully fertilized following insemination during IVF.
Time frame: Approximately 16-20 hours after insemination.
Cleavage Rate
Proportion of fertilized embryos progressing to the cleavage stage.
Time frame: Day 2-3 after fertilization.
Blastocyst Formation Rate
Proportion of embryos that develop to the blastocyst stage.
Time frame: Day 5-6 after fertilization.
Embryo Quality at Cleavage Stage
Embryo quality assessed according to standard morphological criteria at the cleavage stage.
Time frame: Day 3 after fertilization.
Embryo Quality at Blastocyst Stage
Embryo quality assessed according to standard morphological criteria at the blastocyst stage.
Time frame: Day 5-6 after fertilization.
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Biochemical Pregnancy Rate
Proportion of participants with biochemical pregnancy, defined as a detectable increase in serum β-hCG concentration following embryo transfer.
Time frame: Approximately 10-14 days after embryo transfer.
Progressive Motile Sperm Count After Processing
Number of progressively motile spermatozoa present after sperm processing.
Time frame: Immediately after sperm processing on the day of oocyte retrieval.
Total Sperm Motility After Processing
Percentage of spermatozoa showing any type of motility following sperm processing.
Time frame: Immediately after sperm processing on the day of oocyte retrieval.
Progressive Sperm Motility After Processing
Percentage of spermatozoa exhibiting progressive motility after sperm processing.
Time frame: Immediately after sperm processing on the day of oocyte retrieval.