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Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to develop an artificial intelligence platform for the analysis of sperm samples and prediction of their clinical potential, in 500 semen samples, in an in vitro study over 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVF/ICSI Cycles Using Partner Semen | Couples undergoing IVF/ICSI treatment using ejaculated partner semen |
| |
| IVF/ICSI Cycles Using Donor Semen | Women undergoing IVF/ICSI treatment using donor semen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swim-up | Device | Sperm samples will be processed by swim-up technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Predictive performance of AI models for reproductive outcomes | Area Under the Receiver Operating Characteristic Curve (AUC) and R² (for continuous outcomes) evaluating the ability of the AI model to predict fertilization rate, blastocyst development rate, and pregnancy outcomes using pseudonymized clinical and semen analysis data. | Up to confirmation of clinical pregnancy: approximately 6-8 weeks after embryo transfer. |
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Male participants:
Inclusion Criteria:
Exclusion Criteria:
Female participants:
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Exclusion Criteria:
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Men and women undergoing IVF/ICSI treatment at participating fertility clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matias D. 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 |
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| Density gradient centrifugation | Device | Sperm samples will be processed by density gradient centrifugation |
|
| HyperSperm | Device | Sperm samples will be processed by HyperSperm |
|
| Fertty | Recruiting | Barcelona | Barcelona | 08010 | Spain |
|
| CIRH | Recruiting | Barcelona | Barcelona | 08017 | Spain |
|
| Fertilab Barcelona | Recruiting | Barcelona | Barcelona | 08017 | Spain |
|
| Natuvitro | Recruiting | Barcelona | Barcelona | 08029 | Spain |
|
| ID | Term |
|---|---|
| D007246 | Infertility |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002499 | Centrifugation, Density Gradient |
| ID | Term |
|---|---|
| D014461 | Ultracentrifugation |
| D002498 | Centrifugation |
| D008919 | Investigative Techniques |
| D002623 | Chemistry Techniques, Analytical |
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