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Myo-inositol and an Antioxidant Mix for the Treatment of Vietnamese Infertile Men

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ClinicalTrials.gov Identifier: NCT03726450
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hung Nguyen Ba, Andrology and Fertility Hospital of Hanoi

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

Condition or disease Intervention/treatment Phase
Male Infertility Dietary Supplement: Andrositol Plus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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?
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019


Arm Intervention/treatment
Experimental: Andrositol Plus
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
Dietary Supplement: Andrositol Plus
Myo-inositol

Dietary Supplement: Andrositol Plus
N-Acetyl-Cysteine

Dietary Supplement: Andrositol Plus
Folic Acid

Dietary Supplement: Andrositol Plus
Selenium

Dietary Supplement: Andrositol Plus
L-arginine

Dietary Supplement: Andrositol Plus
L-carnitine

Dietary Supplement: Andrositol Plus
Vitamin E




Primary Outcome Measures :
  1. change in sperm motility [ Time Frame: spermatozoa motility will be analyzed after 3 months of treatment ]
    spermatozoa motility will be evaluated through microscopical evalutation


Secondary Outcome Measures :
  1. change in sperm morphology [ Time Frame: spermatozoa morphology will be analyzed at the enrollment and after 3 months of treatmentanalyzed ]
    spermatozoa morphology will be evaluated through microscopical evalutation

  2. change in sperm vitality [ Time Frame: spermatozoa vitality will be analyzed after 3 months of treatment ]
    spermatozoa vitality will be evaluated through vitality test with methylene blue

  3. change in sperm count [ Time Frame: spermatozoa count will be 3 months of treatment ]
    spermatozoa count will be evaluated through microscopical evalutation

  4. change in seminal fluid viscosity [ Time Frame: semen Hyper-viscosity will be analyzed after 3 months of treatment ]
    Viscosity will be determined after ejaculation by gently aspirating semen into a 5 ml pipette and then producing semen drops.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726450


Locations
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Vietnam
Hung Nguyen Recruiting
Hanoi, Vietnam
Contact: Hung three Nguyen, Medical doctor    +84 989 200 940    hung2779@gmail.com   
Sponsors and Collaborators
Andrology and Fertility Hospital of Hanoi

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Responsible Party: Hung Nguyen Ba, Andrologist, Andrology and Fertility Hospital of Hanoi
ClinicalTrials.gov Identifier: NCT03726450     History of Changes
Other Study ID Numbers: MAVIM
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hung Nguyen Ba, Andrology and Fertility Hospital of Hanoi:
myo-inositol
N-acetyl-cysteine
semen hyperviscosity
idiopathic male infertility
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Inositol
Acetylcysteine
Antioxidants
N-monoacetylcystine
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antidotes