RecruitingNCT06742437

Efficacy and Safety of a New Sperm Capacitation Method

Efficacy and Safety of a New Sperm Capacitation Method: a Prospective in Vitro Study on Semen Samples


Sponsor

Fecundis Lab SL

Enrollment

300 participants

Start Date

Jan 14, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 60 Years

Inclusion Criteria1

  • Ability to provide a semen sample via masturbation

Exclusion Criteria4

  • Current diagnosis of a sexually transmitted infection (STI)
  • Previous diagnosis of hepatitis A, B, C, D, or HIV
  • Prior participation in this study
  • Participation in a clinical trial involving an intervention within the last 3 months

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Interventions

DEVICEStandard sperm preparation

Sperm samples in the control group will undergo traditional processing

DEVICEHyperSperm

Sperm samples in the experimental group will undergo product-specific processing


Locations(4)

Eugin Barcelona

Barcelona, Barcelona, Spain

Fertty

Barcelona, Barcelona, Spain

CIRH

Barcelona, Barcelona, Spain

Natuvitro

Barcelona, Barcelona, Spain

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NCT06742437


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