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

Lo.Li.Pharma

Status: Completed

Conditions: Male Infertility

Treatments: Diagnostic Test: Andrositol® Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT03677011

100006555

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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249 participants in 2 patient groups

category 1

Other group

Description:

Low responder

Treatment:

Diagnostic Test: Andrositol® Test

category 2

Other group

Description:

Medium Responder and High Responder

Treatment:

Diagnostic Test: Andrositol® Test