NCT03677011

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Lo.Li.Pharma s.r.l · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Male Infertility

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Andrositol® Test	The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure

Timeline

• Start date: 2018-07-01
• Primary completion: 2021-09-01
• Completion: 2021-10-31
• First posted: 2018-09-19
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study