Myo-inositol and an Antioxidant Mix for the Treatment of Vietnamese Infertile Men
Primary Purpose
Male Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Andrositol Plus
Andrositol Plus
Andrositol Plus
Andrositol Plus
Andrositol Plus
Andrositol Plus
Andrositol Plus
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility focused on measuring myo-inositol, N-acetyl-cysteine, semen hyperviscosity, idiopathic male infertility
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hung NguyenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Andrositol Plus
Arm Description
all 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
Outcomes
Primary Outcome Measures
change in sperm motility
spermatozoa motility will be evaluated through microscopical evalutation
Secondary Outcome Measures
change in sperm morphology
spermatozoa morphology will be evaluated through microscopical evalutation
change in sperm vitality
spermatozoa vitality will be evaluated through vitality test with methylene blue
change in sperm count
spermatozoa count will be evaluated through microscopical evalutation
change in seminal fluid viscosity
Viscosity will be determined after ejaculation by gently aspirating semen into a 5 ml pipette and then producing semen drops.
Full Information
NCT ID
NCT03726450
First Posted
September 7, 2018
Last Updated
December 11, 2019
Sponsor
Andrology and Fertility Hospital of Hanoi
1. Study Identification
Unique Protocol Identification Number
NCT03726450
Brief Title
Myo-inositol and an Antioxidant Mix for the Treatment of Vietnamese Infertile Men
Official Title
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?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andrology and Fertility Hospital of Hanoi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
According to the World Health Organization (WHO), the incidence of infertile couples is relatively high, with a range from 15% to 20% in the developed countries. In accordance with WHO, spermatogenesis disorders occur in almost 50% of all the cases of male infertility. In the recent decades, an unexplained reduction has been found, not only in sperm quality and quantity but also in the volume of the ejaculate. This evidence allows speculations on the number of male infertility factors, which will keep increasing in the future. An important impact on male infertility caused by environmental factors, such as bad habits (alcohol and smoking), body overload and in particular the reluctance of men undergoing prevention is widely reported. A reduced fertility is often related to a lower sperm motility. Over the recent years, the percentage of motile sperms in the ejaculate is constantly reducing. For these reasons, WHO, in the latest edition, indicated a percentage of sperms progressive motility less than 32% as a parameter of the reduced chance of getting pregnant spontaneously. The etiopathogenesis of male infertility is extremely complex, and the factors and processes causing these disorders in the reproduction are different. A common cause of reduced sperms motility seems to be related to the toxic action of reactive oxygen species (ROS). Pathological effects of free radicals in the male reproductive tract are associated with DNA fragmentation, lipid peroxidation, and apoptosis, and these lead to reduced fertility and miscarriages. Due to this evidence, antioxidant species were introduced in the management of male infertility. Between these molecules, Selenium and L-Arginine had shown a strong impact in contrasting ROS generation and restoring the oxidative status of the seminal environment. Myo-inositol (MI) is an isomer of the inositol's family. In nature are present 9 isomers of this sugar-like and MI represents the most abundant one. It plays a key role in more than one cellular pathways as FSH, insulin and TSH second intracellular messenger. It has been also demonstrated an important effect of MI in improving semen parameters such as motility, morphology, and quality, both in vitro and in vivo. From the reported studies, the effect of this isomer seems to be related to an improvement in the membrane potential of spermatozoa's mitochondria and in the reduction of the semen amorphous material that frequently impairs male fertility. Based on this evidence, recent scientific researches have been focused on the clinical use of MI in the management of male infertility caused by semen alterations. A further growing issue impairing male fertility is semen hyperviscosity (SHV). SHV is a condition that can seriously impair the physical and chemical characteristics of the seminal fluid and it can have a serious impact on sperm function. Worth of spreading, SHV seems to be associated with reduced sperm motility, possibly due to a 'trapping effect' that prevents normal sperm progression through the female genital tract. N-acetyl-L-cysteine (NAC) is a derivative of the naturally occurring amino acid L-cysteine that has free radical scavenging activity and it is also commonly used as a mucolytic agent. In addition to NAC antioxidant activity, Cifci et al. found it effective in reducing semen viscosity and its oxidative status as well as in increasing semen volume and spermatozoa motility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
myo-inositol, N-acetyl-cysteine, semen hyperviscosity, idiopathic male infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Andrositol Plus
Arm Type
Experimental
Arm Description
all 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Andrositol Plus
Intervention Description
Myo-inositol
Intervention Type
Dietary Supplement
Intervention Name(s)
Andrositol Plus
Intervention Description
N-Acetyl-Cysteine
Intervention Type
Dietary Supplement
Intervention Name(s)
Andrositol Plus
Intervention Description
Folic Acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Andrositol Plus
Intervention Description
Selenium
Intervention Type
Dietary Supplement
Intervention Name(s)
Andrositol Plus
Intervention Description
L-arginine
Intervention Type
Dietary Supplement
Intervention Name(s)
Andrositol Plus
Intervention Description
L-carnitine
Intervention Type
Dietary Supplement
Intervention Name(s)
Andrositol Plus
Intervention Description
Vitamin E
Primary Outcome Measure Information:
Title
change in sperm motility
Description
spermatozoa motility will be evaluated through microscopical evalutation
Time Frame
spermatozoa motility will be analyzed after 3 months of treatment
Secondary Outcome Measure Information:
Title
change in sperm morphology
Description
spermatozoa morphology will be evaluated through microscopical evalutation
Time Frame
spermatozoa morphology will be analyzed at the enrollment and after 3 months of treatmentanalyzed
Title
change in sperm vitality
Description
spermatozoa vitality will be evaluated through vitality test with methylene blue
Time Frame
spermatozoa vitality will be analyzed after 3 months of treatment
Title
change in sperm count
Description
spermatozoa count will be evaluated through microscopical evalutation
Time Frame
spermatozoa count will be 3 months of treatment
Title
change in seminal fluid viscosity
Description
Viscosity will be determined after ejaculation by gently aspirating semen into a 5 ml pipette and then producing semen drops.
Time Frame
semen Hyper-viscosity will be analyzed after 3 months of treatment
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Hung Nguyen
City
Hanoi
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung three Nguyen, Medical doctor
Phone
+84 989 200 940
Email
hung2779@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Myo-inositol and an Antioxidant Mix for the Treatment of Vietnamese Infertile Men
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