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

NCT03677011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2022-04-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lo.Li.Pharma s.r.l

    lead INDUSTRY

Principal Investigators

  • Tih T. Tan, Ms · HRC Pasadena 333 S Arroyo Pkwy Fl 3 Pasadena, CA 91105

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-09-01
Completion
2021-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03677011 on ClinicalTrials.gov