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NCT Number: NCT07478549

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IFER, Buenos Aires, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard sperm preparation

Device

Standard sperm preparation

HyperSperm

Device

Multi-step sperm preparation

Primary outcomes

  1. 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).

    Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle.

Secondary outcomes

  1. Clinical Pregnancy Rate

    Time frame: 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.

  2. Fertilization Rate

    Time frame: Approximately 16-20 hours after insemination.

    Proportion of oocytes successfully fertilized following insemination during IVF.

  3. Cleavage Rate

    Time frame: Day 2-3 after fertilization.

    Proportion of fertilized embryos progressing to the cleavage stage.

  4. Blastocyst Formation Rate

    Time frame: Day 5-6 after fertilization.

    Proportion of embryos that develop to the blastocyst stage.

  5. Embryo Quality at Cleavage Stage

    Time frame: Day 3 after fertilization.

    Embryo quality assessed according to standard morphological criteria at the cleavage stage.

  6. Embryo Quality at Blastocyst Stage

    Time frame: Day 5-6 after fertilization.

    Embryo quality assessed according to standard morphological criteria at the blastocyst stage.

  7. Biochemical Pregnancy Rate

    Time frame: 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.

  8. Progressive Motile Sperm Count After Processing

    Time frame: Immediately after sperm processing on the day of oocyte retrieval.

    Number of progressively motile spermatozoa present after sperm processing.

  9. Total Sperm Motility After Processing

    Time frame: Immediately after sperm processing on the day of oocyte retrieval.

    Percentage of spermatozoa showing any type of motility following sperm processing.

  10. Progressive Sperm Motility After Processing

    Time frame: Immediately after sperm processing on the day of oocyte retrieval.

    Percentage of spermatozoa exhibiting progressive motility after sperm processing.

Other outcomes

  1. Ongoing Pregnancy Rate

    Time frame: Up to 12-14 weeks of gestation.

    Proportion of pregnancies progressing beyond the first trimester without pregnancy loss.

  2. Live Birth Rate

    Time frame: At delivery. Approximately 38-42 weeks after embryo transfer.

    Proportion of pregnancies resulting in the birth of a live neonate.

  3. Neonatal Sex Distribution

    Time frame: At birth. Approximately 38-42 weeks after embryo transfer.

    Sex of neonates born from pregnancies resulting from the study.

  4. Birth Weight

    Time frame: At birth. Approximately 38-42 weeks after embryo transfer.

    Birth weight of neonates resulting from pregnancies in the study.

  5. Gestational Age at Birth

    Time frame: At birth. Approximately 38-42 weeks after embryo transfer.

    Gestational age of the neonate at the time of delivery.

  6. Mode of Delivery

    Time frame: At birth. Approximately 38-42 weeks after embryo transfer.

    Type of delivery, categorized as vaginal delivery or cesarean section.

  7. Multiple Pregnancy Rate

    Time frame: 5-7 weeks of gestation.

    Proportion of pregnancies resulting in multiple gestations, defined as the presence of more than one intrauterine gestational sac detected by ultrasound.

  8. Spontaneous Abortion Rate

    Time frame: From confirmation of clinical pregnancy up to 20 weeks of gestation.

    Proportion of pregnancies resulting in spontaneous pregnancy loss before 20 weeks of gestation.

  9. Neonatal Examination at Hospital Discharge

    Time frame: Within 1 week after delivery (approximately 38-43 weeks after embryo transfer).

    Clinical neonatal examination performed at hospital discharge to assess the overall health status of the newborn and identify any congenital anomalies.

  10. Infant Weight at Follow-Up

    Time frame: 6 and 12 months of age.

    Body weight of infants resulting from pregnancies in the study, measured during pediatric follow-up visits.

  11. Infant Length at Follow-Up

    Time frame: 6 and 12 months of age.

    Body length of infants resulting from pregnancies in the study, measured during pediatric follow-up visits.

  12. Achievement of Developmental Milestones

    Time frame: 6 and 12 months of age.

    Assessment of age-appropriate developmental milestones during pediatric follow-up visits.

  13. Congenital Anomalies

    Time frame: From birth up to 12 months of age.

    Number of infants diagnosed with congenital anomalies during the follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariano G Buffone, PhD

CONTACT

[email protected]

+54114783 2869 ext. +1314

Sponsors and collaborators

Lead sponsor

Fecundis Lab SL

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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