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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Device: Standard Sperm Preparation; Device: HyperSperm

• Study Type: Interventional
• Enrollment (Estimated): 202
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariano G Buffone, PhD; Phone Number: +1314 +54114783 2869; Email: buffone@fecundis.com

Study Locations

• Argentina
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, 1425
      • Pregna
    • Buenos Aires, Buenos Aires F.D., Argentina, 1115
      • IFER
      • Contact: Fabian Lorenzo, MD; Phone Number: +54 9 11 6707-8521; Email: fabian.lorenzo@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Sperm Preparation; Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.	Device: Standard Sperm Preparation; Standard sperm preparation
Experimental: HyperSperm; Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.	Device: HyperSperm; Multi-step sperm preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Euploidy Rate	Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle.	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

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate	Proportion of subjects with a clinical pregnancy, defined as the presence of an intrauterine gestational sac detected by ultrasound.	5-7 weeks of gestation following embryo transfer.
Fertilization Rate	Proportion of oocytes successfully fertilized following insemination during IVF.	Approximately 16-20 hours after insemination.
Cleavage Rate	Proportion of fertilized embryos progressing to the cleavage stage.	Day 2-3 after fertilization.
Blastocyst Formation Rate	Proportion of embryos that develop to the blastocyst stage.	Day 5-6 after fertilization.
Embryo Quality at Cleavage Stage	Embryo quality assessed according to standard morphological criteria at the cleavage stage.	Day 3 after fertilization.
Embryo Quality at Blastocyst Stage	Embryo quality assessed according to standard morphological criteria at the blastocyst stage.	Day 5-6 after fertilization.
Biochemical Pregnancy Rate	Proportion of participants with biochemical pregnancy, defined as a detectable increase in serum β-hCG concentration following embryo transfer.	Approximately 10-14 days after embryo transfer.
Progressive Motile Sperm Count After Processing	Number of progressively motile spermatozoa present after sperm processing.	Immediately after sperm processing on the day of oocyte retrieval.
Total Sperm Motility After Processing	Percentage of spermatozoa showing any type of motility following sperm processing.	Immediately after sperm processing on the day of oocyte retrieval.
Progressive Sperm Motility After Processing	Percentage of spermatozoa exhibiting progressive motility after sperm processing.	Immediately after sperm processing on the day of oocyte retrieval.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing Pregnancy Rate	Proportion of pregnancies progressing beyond the first trimester without pregnancy loss.	Up to 12-14 weeks of gestation.
Live Birth Rate	Proportion of pregnancies resulting in the birth of a live neonate.	At delivery. Approximately 38-42 weeks after embryo transfer.
Neonatal Sex Distribution	Sex of neonates born from pregnancies resulting from the study.	At birth. Approximately 38-42 weeks after embryo transfer.
Birth Weight	Birth weight of neonates resulting from pregnancies in the study.	At birth. Approximately 38-42 weeks after embryo transfer.
Gestational Age at Birth	Gestational age of the neonate at the time of delivery.	At birth. Approximately 38-42 weeks after embryo transfer.
Mode of Delivery	Type of delivery, categorized as vaginal delivery or cesarean section.	At birth. Approximately 38-42 weeks after embryo transfer.
Multiple Pregnancy Rate	Proportion of pregnancies resulting in multiple gestations, defined as the presence of more than one intrauterine gestational sac detected by ultrasound.	5-7 weeks of gestation.
Spontaneous Abortion Rate	Proportion of pregnancies resulting in spontaneous pregnancy loss before 20 weeks of gestation.	From confirmation of clinical pregnancy up to 20 weeks of gestation.
Neonatal Examination at Hospital Discharge	Clinical neonatal examination performed at hospital discharge to assess the overall health status of the newborn and identify any congenital anomalies.	Within 1 week after delivery (approximately 38-43 weeks after embryo transfer).
Infant Weight at Follow-Up	Body weight of infants resulting from pregnancies in the study, measured during pediatric follow-up visits.	6 and 12 months of age.
Infant Length at Follow-Up	Body length of infants resulting from pregnancies in the study, measured during pediatric follow-up visits.	6 and 12 months of age.
Achievement of Developmental Milestones	Assessment of age-appropriate developmental milestones during pediatric follow-up visits.	6 and 12 months of age.
Congenital Anomalies	Number of infants diagnosed with congenital anomalies during the follow-up period.	From birth up to 12 months of age.

Collaborators and Investigators

• Sponsor: Fecundis Lab SL
• Investigators: Principal Investigator: Mariano G Buffone, PhD, Fecundis Lab SL

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: Fecundis_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No