Infertility
Conditions
Brief summary
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.
Interventions
Standard sperm preparation
DEVICEHyperSperm
Multi-step sperm preparation
Sponsors
Fecundis Lab SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
General * Couples undergoing in vitro fertilization (IVF) treatment. * Planned use of fresh sperm samples obtained by masturbation. Female * Age between 20 and 42 years. * Antral follicle count ≥ 4. * Eligible for ovarian stimulation and embryo transfer. Male * Age between 20 and 45 years. * Fresh semen sample (not cryopreserved). * Pre-processing sperm concentration ≥ 5 × 10⁶ sperm/mL.
Exclusion criteria
General * Active sexually transmitted infection (STI). * Use of donor sperm. * Medical conditions contraindicating pregnancy or the IVF procedure. Female * Uterine anomalies associated with distortion of the uterine cavity. * Absence of one ovary or functional disorders preventing ovulation. * Diabetes mellitus or other metabolic disorders. * Recurrent pregnancy loss, defined as more than two clinical pregnancies without live birth. Male \- Any medical condition affecting semen quality that, in the investigator's opinion, may interfere with study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Euploidy Rate | From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization). | Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | 5-7 weeks of gestation following embryo transfer. | Proportion of subjects with a clinical pregnancy, defined as the presence of an intrauterine gestational sac detected by ultrasound. |
| Fertilization Rate | Approximately 16-20 hours after insemination. | Proportion of oocytes successfully fertilized following insemination during IVF. |
| Cleavage Rate | Day 2-3 after fertilization. | Proportion of fertilized embryos progressing to the cleavage stage. |
| Blastocyst Formation Rate | Day 5-6 after fertilization. | Proportion of embryos that develop to the blastocyst stage. |
| Embryo Quality at Cleavage Stage | Day 3 after fertilization. | Embryo quality assessed according to standard morphological criteria at the cleavage stage. |
| Embryo Quality at Blastocyst Stage | Day 5-6 after fertilization. | Embryo quality assessed according to standard morphological criteria at the blastocyst stage. |
| Biochemical Pregnancy Rate | Approximately 10-14 days after embryo transfer. | Proportion of participants with biochemical pregnancy, defined as a detectable increase in serum β-hCG concentration following embryo transfer. |
| Progressive Motile Sperm Count After Processing | Immediately after sperm processing on the day of oocyte retrieval. | Number of progressively motile spermatozoa present after sperm processing. |
| Total Sperm Motility After Processing | Immediately after sperm processing on the day of oocyte retrieval. | Percentage of spermatozoa showing any type of motility following sperm processing. |
| Progressive Sperm Motility After Processing | Immediately after sperm processing on the day of oocyte retrieval. | Percentage of spermatozoa exhibiting progressive motility after sperm processing. |
Countries
Argentina
Contacts
CONTACTMariano G Buffone, PhD
PRINCIPAL_INVESTIGATORMariano G Buffone, PhD
Fecundis Lab SL
Outcome results
None listed