Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF

Study Overview
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Brief Summary
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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.

Official Title
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Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential of the Sperm in the in Vitro Fertilization (IVF) Procedures.

Conditions
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Male Infertility

Intervention / Treatment
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* Diagnostic Test: Andrositol® Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male partners of couples undergoing an egg donor cycles Exclusion Criteria: sperm volume lower than 1 ml sperm count lower than 5 X 106 /ml total sperm motility lower than 10%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: category 1<br>Low responder | Diagnostic Test: Andrositol® Test<br>* The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure<br>|
| Other: category 2<br>Medium Responder and High Responder | Diagnostic Test: Andrositol® Test<br>* The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, myo-inositol, fertilization rate, Intracytoplasmic Sperm Injection, sperm