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

Sponsor
Fecundis Lab SL
Study ID
NCT07478549
Status
Not Yet Recruiting

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Conditions

  • Infertility

Eligibility Criteria

Sex
ALL
Age
20 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Sperm Preparation — DEVICE
    Standard sperm preparation
  • HyperSperm — DEVICE
    Multi-step sperm preparation

Study Details

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.

Key Dates

First listed
Mar 17, 2026
Start date
Dec 31, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
202 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Sperm Preparation
    Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
  • Experimental: HyperSperm
    Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.

Primary Outcome Measure

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). ]

Central Contacts

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