Asthenozoospermia, Male Infertility, Oligozoospermia, Reproductive Issues, Teratozoospermia
Conditions
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.
Interventions
Sperm samples in the control group will undergo traditional processing
DEVICEHyperSperm
Sperm samples in the experimental group will undergo product-specific processing
Sponsors
Fecundis Lab SL
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyperactivation | 2 hours | Percentage of sperm cells displaying hyperactivated motility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm vitality | 2 hours | Percentage of viable sperm cells |
| DNA fragmentation | 2 hours | Percentage of TUNEL-positive sperm cells |
| Sperm motility | 2 hours | Percentage of motile sperm cells |
| Survival | 20 hours | Percentage of motile sperm cells after overnight incubation |
Countries
Spain
Contacts
CONTACTMatias Gomez Elias, PhD
PRINCIPAL_INVESTIGATORMariona Rius Mas, PhD
Fertty
Outcome results
None listed