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Status unknownNCT03726450Updated Dec 12, 2019

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

An interventional study of Andrositol Plus and Andrositol Plus in Male Infertility, sponsored by Andrology and Fertility Hospital of Hanoi. Status unknown at 1 site in Vietnam. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-12-12.

Sponsored by Andrology and Fertility Hospital of Hanoi · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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

Read the 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.

02

Conditions studied

  • Male Infertility

Keywords

  • myo-inositol
  • N-acetyl-cysteine
  • semen hyperviscosity
  • idiopathic male infertility
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 55 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

This is the only study on the registry with Andrology and Fertility Hospital of Hanoi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • 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

Interventions

  • Dietary supplementAndrositol Plus

    Myo-inositol

  • Dietary supplementAndrositol Plus

    N-Acetyl-Cysteine

  • Dietary supplementAndrositol Plus

    Folic Acid

  • Dietary supplementAndrositol Plus

    Selenium

  • Dietary supplementAndrositol Plus

    L-arginine

  • Dietary supplementAndrositol Plus

    L-carnitine

  • Dietary supplementAndrositol Plus

    Vitamin E

06

What researchers measure

Primary outcomes

  1. change in sperm motility

    spermatozoa motility will be evaluated through microscopical evalutation

    Time frame: spermatozoa motility will be analyzed after 3 months of treatment

Secondary outcomes

  1. change in sperm morphology

    spermatozoa morphology will be evaluated through microscopical evalutation

    Time frame: spermatozoa morphology will be analyzed at the enrollment and after 3 months of treatmentanalyzed

  2. change in sperm vitality

    spermatozoa vitality will be evaluated through vitality test with methylene blue

    Time frame: spermatozoa vitality will be analyzed after 3 months of treatment

  3. change in sperm count

    spermatozoa count will be evaluated through microscopical evalutation

    Time frame: spermatozoa count will be 3 months of treatment

  4. 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.

    Time frame: semen Hyper-viscosity will be analyzed after 3 months of treatment

07

Study locations

1 of 1 sites recruiting
  • Hung Nguyen
    Hanoi, Vietnam
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03726450
Lead sponsor
Andrology and Fertility Hospital of Hanoi
Responsible party
Hung Nguyen Ba (Andrologist, Andrology and Fertility Hospital of Hanoi) — Principal investigator
First posted
Oct 31, 2018
Start date
Nov 1, 2018
Primary completion
Feb 1, 2020 (estimated)
Completion
Mar 1, 2020 (estimated)
Last update
Dec 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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