Back to resultsAndrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF
Primary Purpose
Male Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Andrositol® Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Male Infertility focused on measuring myo-inositol, fertilization rate, infertility, Intracytoplasmic Sperm Injection, sperm
Eligibility 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%
Sites / Locations
- HRC Pasadena
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
category 1
category 2
Arm Description
Low responder
Medium Responder and High Responder
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Increment of implantation rate
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
embryo development
the number of blastocysts for each patient at day +5, +6, +7
embryo euploidy
Embryo euploidy for each patient at day +10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03677011
Brief Title
Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF
Official Title
Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential of the Sperm in the in Vitro Fertilization (IVF) Procedures.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
myo-inositol, fertilization rate, infertility, Intracytoplasmic Sperm Injection, sperm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
category 1
Arm Type
Other
Arm Description
Low responder
Arm Title
category 2
Arm Type
Other
Arm Description
Medium Responder and High Responder
Intervention Type
Diagnostic Test
Intervention Name(s)
Andrositol® Test
Intervention Description
The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure
Primary Outcome Measure Information:
Title
increment of the fertilization rate
Description
measurement of the % oocytes become fertilized by sperm cells. This outcome, is calculated for each patient at day + 1 (14-20h after icsi)
Time Frame
up to 20 hours after ICSI
Secondary Outcome Measure Information:
Title
Increment of implantation rate
Description
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
Time Frame
up to 10 days after ICSI
Title
embryo development
Description
the number of blastocysts for each patient at day +5, +6, +7
Time Frame
up to 6 days after ICSI
Title
embryo euploidy
Description
Embryo euploidy for each patient at day +10
Time Frame
from 10 days after ICSI
10. Eligibility
Sex
Male
Gender Based
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.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tih T. Tan, Ms
Organizational Affiliation
HRC Pasadena 333 S Arroyo Pkwy Fl 3 Pasadena, CA 91105
Official's Role
Principal Investigator
Facility Information:
Facility Name
HRC Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF
We'll reach out to this number within 24 hrs