Safety Evaluation of the HyperSperm Sperm Preparation Procedure for In Vitro Fertilization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Sperm Preparation, HyperSperm.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: 20 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Multicenter, Randomized Clinical Trial Evaluating the Safety of the HyperSperm Sperm Preparation Procedure.
Overview
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
- Device Standard Sperm Preparation
Standard sperm preparation - Device HyperSperm
Multi-step sperm preparation
Primary outcome measures
- Euploidy Rate [Time frame: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).]
Secondary outcome measures (10)
- Clinical Pregnancy Rate [Time frame: 5-7 weeks of gestation following embryo transfer.]
- Fertilization Rate [Time frame: Approximately 16-20 hours after insemination.]
- Cleavage Rate [Time frame: Day 2-3 after fertilization.]
- Blastocyst Formation Rate [Time frame: Day 5-6 after fertilization.]
- Embryo Quality at Cleavage Stage [Time frame: Day 3 after fertilization.]
- Embryo Quality at Blastocyst Stage [Time frame: Day 5-6 after fertilization.]
- Biochemical Pregnancy Rate [Time frame: Approximately 10-14 days after embryo transfer.]
- Progressive Motile Sperm Count After Processing [Time frame: Immediately after sperm processing on the day of oocyte retrieval.]
- Total Sperm Motility After Processing [Time frame: Immediately after sperm processing on the day of oocyte retrieval.]
- Progressive Sperm Motility After Processing [Time frame: Immediately after sperm processing on the day of oocyte retrieval.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Argentina · 2 centers
- IFER — Buenos Aires
- Pregna — Buenos Aires
Identifiers
NCT: NCT07478549 · Fecundis_3