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Low recruitment
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The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads, magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin V is a protein with a high affinity for the molecule phosphatidylserine. This system allow us to eliminate those spermatozoids which have begun the apoptosis and have phosphatidylserine residues on their membrane surface. Using this technique, the apoptotic spermatozoids will join the microbeads and consequently be retained in a column applying a magnetic field.
Recent studies show the benefits of spermatozoid selection using MACS and the improvement in mobility, viability, DNA fragmentation and fertilization potential. It has also been observed an improvement in the embryo cells division rate, clinical pregnancy rates and spermatozoid survival after thawing. However, it is necessary to perform new clinical studies in order to evaluate the real potential of this technology and its safety.
The purpose of this study is to evaluate the effect of the MACS technique on the clinical results of good-prognosis patients who are going through IVF/ICSI treatments in order to achieve a pregnancy.
The hypothesis of this study is that the application of the MACS technique in assisted reproduction treatments is associated with a better embryo quality and pregnancy rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NO MACS + Time-lapse technology | Active Comparator | The sperm capacitation will be performed through a density gradient. This sperm will be used in the IVF/ICSI treatment of the patient and the embryos obtained will be cultured using time-lapse technology (Embryoscope). |
|
| MACS + time-lapse technology | Experimental | The sperm capacitation will be performed through a density gradient. After that, it will be subjected to the MACS technique in order to select the non-apoptotic spermatozoids. This sperm will be used in the IVF/ICSI treatment of the patient and the embryos obtained will be cultured using time-lapse technology (Embryoscope). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MACS | Other | The sperm will be subjected to capacitation through a density gradient together with the MACS technique in order to select the non-apoptotic spermatozoids. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | 14 months | |
| Embryo quality | According to ASEBIR criteria | 14 months |
| Implantation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Blasco, MSc | Vida Recoletas Sevilla | Study Chair |
| Rocío Quiroga, MSc | Vida Recoletas Sevilla | Principal Investigator |
| Cristina González, PhD | Vida Recoletas Sevilla | Study Chair |
| Cinzia Caligara, MD | Vida Recoletas Sevilla | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Sevilla | Seville | 41011 | Spain |
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| NO MACS | Other | The sperm capacitation will be performed through a density gradient. The MACS technique will not be applied. |
|
| 14 months |