NCT03677011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

July 25, 2018

Last Update Submit

April 5, 2022

Conditions

Male Infertility

Keywords

myo-inositolfertilization rateinfertilityIntracytoplasmic Sperm Injectionsperm

Outcome Measures

Primary Outcomes (1)

  • increment of the fertilization rate

    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 Outcomes (3)

  • Increment of implantation rate

    up to 10 days after ICSI

  • embryo development

    up to 6 days after ICSI

  • embryo euploidy

    from 10 days after ICSI

Study Arms (2)

category 1

OTHER

Low responder

Diagnostic Test: Andrositol® Test

category 2

OTHER

Medium Responder and High Responder

Diagnostic Test: Andrositol® Test

Interventions

Andrositol® TestDIAGNOSTIC_TEST

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

category 1category 2

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSince we are testing the predictive value of a sperm test, the gender of the prospective subjects will be restricted to male partners of couples undergoing an ICSI treatment.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male partners of couples undergoing an egg donor cycles

You may not qualify if:

  • sperm volume lower than 1 ml
  • sperm count lower than 5 X 106 /ml
  • total sperm motility lower than 10%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HRC Pasadena

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Infertility, MaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Tih T. Tan, Ms

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2018

First Posted

September 19, 2018

Study Start

July 1, 2018

Primary Completion

September 1, 2021

Study Completion

October 31, 2021

Last Updated

April 6, 2022

Record last verified: 2022-04

Locations

US(1)