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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard sperm preparation | Device | Sperm samples in the control group will undergo traditional processing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hyperactivation | Percentage of sperm cells displaying hyperactivated motility | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm vitality | Percentage of viable sperm cells | 2 hours |
| DNA fragmentation | Percentage of TUNEL-positive sperm cells | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matias Gomez Elias, PhD | Contact | +34624174355 | mgomezelias@fecundis.com |
| Name | Affiliation | Role |
|---|---|---|
| Mariona Rius Mas, PhD | Fertty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eugin Barcelona | Recruiting | Barcelona | Barcelona | 08006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41572335 | Derived | Martinez-Vallejo MJ, Carrasquel-Martinez G, Artigues RN, Lattes K, Varea RL, Mas MR, Guirado SR, Ibanez E, Gomez-Elias MD, Buffone MG. Efficacy and safety evaluation of HyperSperm treatment in human semen samples. J Transl Med. 2026 Jan 22;24(1):253. doi: 10.1186/s12967-025-07656-z. |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D053627 | Asthenozoospermia |
| D009845 | Oligospermia |
| D000072660 | Teratozoospermia |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| HyperSperm | Device | Sperm samples in the experimental group will undergo product-specific processing |
|
| Sperm motility | Percentage of motile sperm cells | 2 hours |
| Survival | Percentage of motile sperm cells after overnight incubation | 20 hours |
| Fertty | Recruiting | Barcelona | Barcelona | 08010 | Spain |
|
| CIRH | Recruiting | Barcelona | Barcelona | 08017 | Spain |
|
| Natuvitro | Recruiting | Barcelona | Barcelona | 08029 | Spain |
|
| D052801 |
| Male Urogenital Diseases |