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Completed

NCT Number: NCT03677011

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

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.

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

HRC Pasadena

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Andrositol® Test

Diagnostic Test

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

Primary outcomes

  1. increment of the fertilization rate

    Time frame: 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 outcomes

  1. Increment of implantation rate

    Time frame: 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

  2. embryo development

    Time frame: up to 6 days after ICSI

    the number of blastocysts for each patient at day +5, +6, +7

  3. embryo euploidy

    Time frame: from 10 days after ICSI

    Embryo euploidy for each patient at day +10

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2018
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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