Efficacy and Safety of a New Sperm Capacitation Method

NCT ID: NCT06742437

Last Updated: 2025-03-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-14

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Reproductive Issues Male Infertility Asthenozoospermia Oligozoospermia Teratozoospermia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

Sperm samples in the control group will undergo traditional processing

HyperSperm

Intervention Type DEVICE

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

Intervention Type DEVICE

Sperm samples in the control group will undergo traditional processing

HyperSperm

Intervention Type DEVICE

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

Intervention Type DEVICE

Sperm samples in the control group will undergo traditional processing

HyperSperm

Intervention Type DEVICE

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

Intervention Type DEVICE

Sperm samples in the control group will undergo traditional processing

HyperSperm

Intervention Type DEVICE

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

Intervention Type DEVICE

Sperm samples in the control group will undergo traditional processing

HyperSperm

Intervention Type DEVICE

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

Intervention Type DEVICE

HyperSperm

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fecundis Lab SL

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariona Rius Mas, PhD

Role: PRINCIPAL_INVESTIGATOR

Fertty

Locations

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Eugin Barcelona

Barcelona, Barcelona, Spain

Site Status RECRUITING

Fertty

Barcelona, Barcelona, Spain

Site Status RECRUITING

CIRH

Barcelona, Barcelona, Spain

Site Status RECRUITING

Natuvitro

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Matias Gomez Elias, PhD

Role: CONTACT

+34624174355

Facility Contacts

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Rafael Lafuente

Role: primary

+34933221122

Mariona Rius Mas

Role: primary

+34937378190

Karinna Lattes

Role: primary

+34932806535

Raul Noblom Artigues

Role: primary

+34936555888

Other Identifiers

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HyperSperm01

Identifier Type: -

Identifier Source: org_study_id

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