Safety Evaluation of the HyperSperm Sperm Preparation Procedure for In Vitro Fertilization

Prospective, Multicenter, Randomized Clinical Trial Evaluating the Safety of the HyperSperm Sperm Preparation Procedure.

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.

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.