Male InfertilityNCT03677011
Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF
A study testing Andrositol® Test in people with Male Infertility, run by Lo.Li.Pharma s.r.l at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Andrositol® Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male partners of couples undergoing an egg donor cycles
Who cannot join
- sperm volume lower than 1 ml
- sperm count lower than 5 X 106 /ml
- total sperm motility lower than 10%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Male Infertility
- Being tested
- Andrositol® Test
- Keywords
- myo-inositol, fertilization rate, infertility, Intracytoplasmic Sperm Injection, sperm
- Medical subject headings
- Infertility, Male, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andrositol® TestDiagnostic test
The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure
| Study group | Role | What they receive |
|---|---|---|
| category 1 | Other | Low responder Receives: Diagnostic Test: Andrositol® Test |
| category 2 | Other | Medium Responder and High Responder Receives: Diagnostic Test: Andrositol® Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 20 hours after ICSI
Secondary outcomes (3)
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
Measured: up to 10 days after ICSI
embryo development
the number of blastocysts for each patient at day +5, +6, +7
Measured: up to 6 days after ICSI
embryo euploidy
Embryo euploidy for each patient at day +10
Measured: from 10 days after ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Jul 2018
- Primary completion1 Sep 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tih T. Tan, Ms, Principal investigator, HRC Pasadena 333 S Arroyo Pkwy Fl 3 Pasadena, CA 91105
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677011
- Sponsor's protocol ID
- 100006555
- Status last verified
- Apr 2022
- First submitted
- 25 Jul 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential of the Sperm in the in Vitro Fertilization (IVF) Procedures.
- ClinicalTrials.gov ID
- NCT03677011
- Acronym / sponsor ID
- 100006555
- Conditions
- Male Infertility
- Keywords
- myo-inositol, fertilization rate, infertility, Intracytoplasmic Sperm Injection, sperm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| category 1 | Other | Diagnostic Test: Andrositol® TestLow responder |
| category 2 | Other | Diagnostic Test: Andrositol® TestMedium Responder and High Responder |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male partners of couples undergoing an egg donor cycles
Key exclusion criteria (3 listed)
- sperm volume lower than 1 ml
- sperm count lower than 5 X 106 /ml
- total sperm motility lower than 10%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andrositol® TestThe intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure | Diagnostic test | category 1, category 2 |
Primary outcome
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)
3 secondary outcomes
Increment of implantation rate
Time frame: up to 10 days after ICSI
embryo development
Time frame: up to 6 days after ICSI
embryo euploidy
Time frame: from 10 days after ICSI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tih T. Tan, Ms principal investigator
HRC Pasadena 333 S Arroyo Pkwy Fl 3 Pasadena, CA 91105
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Andrositol® Test in people with Male Infertility, run by Lo.Li.Pharma s.r.l at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increment of the fertilization rate (time frame: up to 20 hours after ICSI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.