Myo-inositol and an Antioxidant Mix for the Treatment of Vietnamese Infertile Men
Can Myo-inositol in Combination With N-Acetyl-Cysteine Plus an Antioxidant Mix be Useful for the Management of Men Affected by Idiopathic Infertility and Semen Hyperviscosity?
1 other identifier
interventional
55
1 country
1
Brief Summary
The aim of this study is to evaluate if Myo-inositol, N-Acetyl-Cysteine plus a cocktail of antioxidants could be able to increase spermatozoa parameters and reduce semen hyper-viscosity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
1 active site
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
First Submitted
Initial submission to the registry
September 7, 2018
CompletedFirst Posted
Study publicly available on registry
October 31, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedDecember 12, 2019
March 1, 2019
1.3 years
September 7, 2018
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in sperm motility
spermatozoa motility will be evaluated through microscopical evalutation
spermatozoa motility will be analyzed after 3 months of treatment
Secondary Outcomes (4)
change in sperm morphology
spermatozoa morphology will be analyzed at the enrollment and after 3 months of treatmentanalyzed
change in sperm vitality
spermatozoa vitality will be analyzed after 3 months of treatment
change in sperm count
spermatozoa count will be 3 months of treatment
change in seminal fluid viscosity
semen Hyper-viscosity will be analyzed after 3 months of treatment
Study Arms (1)
Andrositol Plus
EXPERIMENTALall the patients will be treated for three months with a dietary supplement containing Myo-inositol, NAC, Folic acid, selenium, vitamin E, L-Arginine and L-Carnitine
Interventions
Eligibility Criteria
You may qualify if:
- BMI \< 29
- One year of unsuccessful sexual intercourses without achieving pregnancy for male factor (idiopathic infertility)
- Normospermia, isolated asthenozoospermia and/or oligoasthenozoospermia
- Semen hyper-viscosity defined as severe, moderate and mild
You may not qualify if:
- The absence of spermatozoa production
- Positive presence of leucocyte and inflammation factor in the seminal fluid
- Positive urea test for the presence of bacteria, protozoa and/or fungi infection
- Diagnosis of cryptorchidism
- Diagnosis of Varicocele of grade 2 or higher
- Diagnosis of Diabetes and other pathology causing oxidative stress
- Concentration alterations of the following hormones: LH, FSH, Testosterone, Prolactin, 17b-estradiol
- Abuse of alcohol and controlled substance
- Smoking cigarettes (\>10 cigarettes/day)
- BMI \> 30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hung Nguyen
Hanoi, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Andrologist
Study Record Dates
First Submitted
September 7, 2018
First Posted
October 31, 2018
Study Start
November 1, 2018
Primary Completion
February 1, 2020
Study Completion
March 1, 2020
Last Updated
December 12, 2019
Record last verified: 2019-03