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Andrositol® test allows to obtain additional information besides the WHO parameters and to evaluate the semen energetic status. The diagnosis is performed by analyzing the semen at two different time points: before the treatment and 30' after the addiction of myo-inositol directly to the semen. The purpose of this study is to evaluate if the responsiveness to the Andrositol® test of a sperm sample can be predictive of its fertilization rate in an ICSI (Intracytoplasmic Sperm Injection) cycle (primary outcome). Secondary outcomes as embryo development, embryo euploidy status and embryo implantation rate will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| category 1 | Other | Low responder |
|
| category 2 | Other | Medium Responder and High Responder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Andrositol® Test | Diagnostic Test | The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| increment of the fertilization rate | measurement of the % oocytes become fertilized by sperm cells. This outcome, is calculated for each patient at day + 1 (14-20h after icsi) | up to 20 hours after ICSI |
| Measure | Description | Time Frame |
|---|---|---|
| Increment of implantation rate | implantation rate is calculated as the number of gestational sacs observed at echographic screening at +5 weeks of pregnancy divided by the number of embryos transferred | up to 10 days after ICSI |
| embryo development |
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Inclusion Criteria:
Exclusion Criteria:
Since we are testing the predictive value of a sperm test, the gender of the prospective subjects will be restricted to male partners of couples undergoing an ICSI treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Tih T. Tan, Ms | HRC Pasadena 333 S Arroyo Pkwy Fl 3 Pasadena, CA 91105 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRC Pasadena | Pasadena | California | 91105 | United States |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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the number of blastocysts for each patient at day +5, +6, +7
| up to 6 days after ICSI |
| embryo euploidy | Embryo euploidy for each patient at day +10 | from 10 days after ICSI |