Efficacy and Safety of a New Sperm Capacitation Method
HyperSperm01
1 other identifier
observational
300
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
4 active sites
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
First Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
December 19, 2024
CompletedStudy Start
First participant enrolled
January 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
February 27, 2026
February 1, 2026
1.4 years
December 12, 2024
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Hyperactivation
Percentage of sperm cells displaying hyperactivated motility
2 hours
Secondary Outcomes (4)
Sperm vitality
2 hours
DNA fragmentation
2 hours
Sperm motility
2 hours
Survival
20 hours
Study Arms (5)
Normozoospermic
Semen samples with normal sperm parameters as defined by the World Health Organization guidelines (e.g., normal sperm concentration, motility, and morphology).
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%).
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%).
Oligozoospermic
Semen samples with a low sperm concentration, below the World Health Organization reference value (i.e., less than 15 million sperm per milliliter).
Cryopreserved semen
Semen samples that have been preserved through freezing and stored at ultra-low temperatures.
Interventions
Sperm samples in the control group will undergo traditional processing
Sperm samples in the experimental group will undergo product-specific processing
Eligibility Criteria
Men attending fertility clinics who provide a semen sample with normal parameters (normozoospermia), or present a male factor (asthenozoospermia, oligozoospermia, teratozoospermia, or a combination thereof).
You may qualify if:
- Ability to provide a semen sample via masturbation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fecundis Lab SLlead
Study Sites (4)
Eugin Barcelona
Barcelona, Barcelona, 08006, Spain
Fertty
Barcelona, Barcelona, 08010, Spain
CIRH
Barcelona, Barcelona, 08017, Spain
Natuvitro
Barcelona, Barcelona, 08029, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariona Rius Mas, PhD
Fertty
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2024
First Posted
December 19, 2024
Study Start
January 14, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02