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

Not Applicable

Completed

• Conditions: Male Infertility
• Interventions: Diagnostic Test: Andrositol® Test

• Registration Number: NCT03677011
• Lead Sponsor: Lo.Li.Pharma s.r.l

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Primary Completion: 2021-09-01
• Study Completion: 2021-10-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 249

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
category 1	Andrositol® Test	Low responder
category 2	Andrositol® Test	Medium Responder and High Responder

Primary Outcome Measures

Name	Time	Method
increment of the fertilization rate	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

Name	Time	Method
Increment of implantation rate	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
embryo development	up to 6 days after ICSI	the number of blastocysts for each patient at day +5, +6, +7
embryo euploidy	from 10 days after ICSI	Embryo euploidy for each patient at day +10

Trial Locations

Locations (1)

HRC Pasadena; 🇺🇸 Pasadena, California, United States