Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-01-14
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normozoospermic
Semen samples with normal sperm parameters as defined by the World Health Organization guidelines (e.g., normal sperm concentration, motility, and morphology).
Standard sperm preparation
Sperm samples in the control group will undergo traditional processing
HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
Teratozoospermic
Semen samples with abnormal sperm morphology, where the percentage of morphologically normal sperm is below the threshold set by the World Health Organization (i.e., 4%).
Standard sperm preparation
Sperm samples in the control group will undergo traditional processing
HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
Asthenozoospermic
Semen samples characterized by reduced sperm motility, where the percentage of progressive motile sperm is below the threshold set by the World Health Organization (i.e., 32%).
Standard sperm preparation
Sperm samples in the control group will undergo traditional processing
HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
Oligozoospermic
Semen samples with a low sperm concentration, below the World Health Organization reference value (i.e., less than 15 million sperm per milliliter).
Standard sperm preparation
Sperm samples in the control group will undergo traditional processing
HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
Cryopreserved semen
Semen samples that have been preserved through freezing and stored at ultra-low temperatures.
Standard sperm preparation
Sperm samples in the control group will undergo traditional processing
HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
Interventions
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Standard sperm preparation
Sperm samples in the control group will undergo traditional processing
HyperSperm
Sperm samples in the experimental group will undergo product-specific processing
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
60 Years
MALE
Yes
Sponsors
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Fecundis Lab SL
OTHER
Responsible Party
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Principal Investigators
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Mariona Rius Mas, PhD
Role: PRINCIPAL_INVESTIGATOR
Fertty
Locations
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Eugin Barcelona
Barcelona, Barcelona, Spain
Fertty
Barcelona, Barcelona, Spain
CIRH
Barcelona, Barcelona, Spain
Natuvitro
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HyperSperm01
Identifier Type: -
Identifier Source: org_study_id
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