Efficacy and Safety of a New Sperm Capacitation Method (HyperSperm01)

Fecundis Lab SL

Status

Enrolling

Conditions

Asthenozoospermia

Teratozoospermia

Male Infertility

Oligozoospermia

Reproductive Issues

Treatments

Device: Standard sperm preparation

Device: HyperSperm

Study type

Observational

Funder types

Other

Identifiers

NCT06742437

HyperSperm01

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

300 participants in 5 patient groups

Normozoospermic

Description:

Semen samples with normal sperm parameters as defined by the World Health Organization guidelines (e.g., normal sperm concentration, motility, and morphology).

Treatment:

Device: HyperSperm

Device: Standard sperm preparation

Teratozoospermic

Description:

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%).

Treatment:

Device: HyperSperm

Device: Standard sperm preparation

Asthenozoospermic

Description:

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%).

Treatment:

Device: HyperSperm

Device: Standard sperm preparation

Oligozoospermic

Description:

Semen samples with a low sperm concentration, below the World Health Organization reference value (i.e., less than 15 million sperm per milliliter).

Treatment:

Device: HyperSperm

Device: Standard sperm preparation

Cryopreserved semen

Description:

Semen samples that have been preserved through freezing and stored at ultra-low temperatures.