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

NCT ID: NCT03677011

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Male Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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category 1

Low responder

Group Type OTHER

Andrositol® Test

Intervention Type DIAGNOSTIC_TEST

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

category 2

Medium Responder and High Responder

Group Type OTHER

Andrositol® Test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Andrositol® Test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tih T. Tan, Ms

Role: PRINCIPAL_INVESTIGATOR

HRC Pasadena 333 S Arroyo Pkwy Fl 3 Pasadena, CA 91105

Locations

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HRC Pasadena

Pasadena, California, United States

Site Status

Countries

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United States

Other Identifiers

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100006555

Identifier Type: -

Identifier Source: org_study_id

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