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Prospective, multi-centric, split-sample, sibling oocyte study evaluating the safety and efficacy of a new method to prepare sperm samples for IVF (in vitro fertilization) / ICSI (intracytoplasmic sperm injection) compared to standard procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Sperm Preparation | Active Comparator | Sperm samples in the control group will undergo traditional processing in the lab prior to insemination. |
|
| HyperSperm | Experimental | Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyperSperm | Device | Multi-step sperm preparation |
| |
| Standard Sperm Preparation |
| Measure | Description | Time Frame |
|---|---|---|
| Development rate to blastocysts | Total blastocysts / total fertilized oocytes | Days 5-6 post insemination |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes | Day 1 post insemination |
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Female:
Inclusion Criteria:
Exclusion Criteria:
Male:
Inclusion Criteria for IVF:
Inclusion Criteria for ICSI:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Buffone, PhD | Fecundis Lab SL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| In Vitro Buenos Aires | Buenos Aires | Buenos Aires F.D. | 1058 | Argentina | ||
| Pregna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42231286 | Derived | Oscoz-Susino N, Gomez-Elias MD, Bisioli C, Horton M, Papayannis M, Martino E, Kopcow L, Attie M, Lavolpe M, Carizza C, Luque GM, Graf CB, Monserrat VT, Navall E, Buffone MG, Krapf D. A multicenter, prospective sibling oocyte study revealed that HyperSperm improves the number and quality of embryos in patients undergoing in vitro fertilization. J Transl Med. 2026 Jun 2;24(1):729. doi: 10.1186/s12967-026-08261-4. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Device |
Standard sperm preparation |
|
| Buenos Aires |
| Buenos Aires F.D. |
| 1425 |
| Argentina |
| WeFIV | Buenos Aires | Buenos Aires F.D. | 1428 | Argentina |
| Fertya | Rosario | Santa Fe Province | 2282 | Argentina |