NCT07478549

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026Aug 2027

Study Start

First participant enrolled

March 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 6, 2026

Last Update Submit

March 13, 2026

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Clinical Pregnancy Rate

    5-7 weeks of gestation following embryo transfer.

  • Fertilization Rate

    Approximately 16-20 hours after insemination.

  • Cleavage Rate

    Day 2-3 after fertilization.

  • Blastocyst Formation Rate

    Day 5-6 after fertilization.

  • Embryo Quality at Cleavage Stage

    Day 3 after fertilization.

  • +5 more secondary outcomes

Other Outcomes (13)

  • Ongoing Pregnancy Rate

    Up to 12-14 weeks of gestation.

  • Live Birth Rate

    At delivery. Approximately 38-42 weeks after embryo transfer.

  • Neonatal Sex Distribution

    At birth. Approximately 38-42 weeks after embryo transfer.

  • +10 more other outcomes

Study Arms (2)

Standard Sperm Preparation

ACTIVE COMPARATOR

Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.

Device: Standard Sperm Preparation

HyperSperm

EXPERIMENTAL

Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.

Device: HyperSperm

Interventions

Standard Sperm PreparationDEVICE

Standard sperm preparation

Standard Sperm Preparation
HyperSpermDEVICE

Multi-step sperm preparation

HyperSperm

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IFER

Buenos Aires, Buenos Aires F.D., 1115, Argentina

Location

Pregna

Buenos Aires, Buenos Aires F.D., 1425, Argentina

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mariano G Buffone, PhD

    Fecundis Lab SL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariano G Buffone, PhD

CONTACT

+54114783 2869buffone@fecundis.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

AR(2)