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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03677011

Enrollment

249

Registered

2018-09-19

Start date

2018-07-01

Completion date

2021-10-31

Last updated

2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Keywords

myo-inositol, fertilization rate, infertility, Intracytoplasmic Sperm Injection, sperm

Brief 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.

Interventions

DIAGNOSTIC_TESTAndrositol® Test

The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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%

Design outcomes

Primary

Measure	Time frame	Description
increment of the fertilization rate	up to 20 hours after ICSI	measurement of the % oocytes become fertilized by sperm cells. This outcome, is calculated for each patient at day + 1 (14-20h after icsi)

Secondary

Measure	Time frame	Description
Increment of implantation rate	up to 10 days after ICSI	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
embryo development	up to 6 days after ICSI	the number of blastocysts for each patient at day +5, +6, +7
embryo euploidy	from 10 days after ICSI	Embryo euploidy for each patient at day +10

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026