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

April 5, 2022 updated by: Lo.Li.Pharma s.r.l

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • HRC Pasadena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: category 1
Low responder
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
Other: category 2
Medium Responder and High Responder
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 20 hours after ICSI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100006555

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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