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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677011
Recruitment Status : Unknown
Verified July 2018 by Lo.Li.Pharma s.r.l.
Recruitment status was:  Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l

Study Description
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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.

Condition or disease Intervention/treatment Phase
Male Infertility Diagnostic Test: Andrositol® Test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential of the Sperm in the in Vitro Fertilization (IVF) Procedures.
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Since 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.
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677011


Contacts
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Contact: Tih T. Tan, Ms (626) 440-9161 TihT@havingbabies.com

Locations
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United States, California
HRC Pasadena Recruiting
Pasadena, California, United States, 91105
Contact: Tih Tan, Ms    626-440-9161    TihT@havingbabies.com   
Sponsors and Collaborators
Lo.Li.Pharma s.r.l
Investigators
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Principal Investigator: Tih T. Tan, Ms HRC Pasadena 333 S Arroyo Pkwy Fl 3 Pasadena, CA 91105
More Information
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Responsible Party: Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier: NCT03677011    
Other Study ID Numbers: 100006555
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Lo.Li.Pharma s.r.l:
myo-inositol
fertilization rate
infertility
Intracytoplasmic Sperm Injection
sperm
Additional relevant MeSH terms:
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Infertility
Infertility, Male