Safety Evaluation of the HyperSperm™ Sperm Preparation Procedure for In Vitro Fertilization (NCT07478549) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety Evaluation of the HyperSperm™ Sperm Preparation Procedure for In Vitro Fertilization
Argentina202 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range20 Years – 45 Years
SexALL
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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.
What they're measuring
1
Euploidy Rate
Timeframe: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).