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Recruiting NCT06742437

Efficacy and Safety of a New Sperm Capacitation Method

— Observational Reproductive Issues Male Infertility Asthenozoospermia Oligozoospermia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard sperm preparation, HyperSperm.
Who it may be relevant to
Registry conditions: Reproductive Issues, Male Infertility, Asthenozoospermia, Oligozoospermia. Basic parameters: 18 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Standard sperm preparation
    Sperm samples in the control group will undergo traditional processing
  • Device HyperSperm
    Sperm samples in the experimental group will undergo product-specific processing

Primary outcome measures

  • Hyperactivation [Time frame: 2 hours]
Secondary outcome measures (4)
  • Sperm vitality [Time frame: 2 hours]
  • DNA fragmentation [Time frame: 2 hours]
  • Sperm motility [Time frame: 2 hours]
  • Survival [Time frame: 20 hours]

Eligibility criteria

Inclusion criteria

  • Ability to provide a semen sample via masturbation

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Spain · 4 centers
  • Eugin Barcelona — Barcelona
  • Fertty — Barcelona
  • CIRH — Barcelona
  • Natuvitro — Barcelona

Publications

  • Martinez-Vallejo MJ, Carrasquel-Martinez G, Artigues RN, Lattes K, Varea RL, Mas MR, Guirado SR, Ibanez E, Gomez-Elias MD, Buffone MG. Efficacy and safety evaluation of HyperSperm treatment in human semen samples. J Transl Med. 2026 Jan 22;24(1):253. doi: 10.1186/s12967-025-07656-z. PMID 41572335

Identifiers

NCT: NCT06742437 · HyperSperm01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗