AzTrials
AzTrials

Male InfertilityNCT03726450

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

A study testing Andrositol Plus in people with Male Infertility, run by Andrology and Fertility Hospital of Hanoi at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 55 years, men only
Conditions the study is for
Male Infertility
What is being tested?
Andrositol Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteVietnam
Study dates
1 Nov 2018to 1 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site, 1 recruiting
  • Hung Nguyen

    Hanoi

    Hung three Nguyen, Medical doctor, +84 989 200 940, hung2779@gmail.com

    Recruiting

Other trials in Vietnam

About this study

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?

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.

Being tested
Andrositol Plus
Keywords
myo-inositol, N-acetyl-cysteine, semen hyperviscosity, idiopathic male infertility
Medical subject headings
Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Andrositol PlusDietary supplement

    Myo-inositol

  • Andrositol PlusDietary supplement

    N-Acetyl-Cysteine

  • Andrositol PlusDietary supplement

    Folic Acid

  • Andrositol PlusDietary supplement

    Selenium

  • Andrositol PlusDietary supplement

    L-arginine

  • Andrositol PlusDietary supplement

    L-carnitine

  • Andrositol PlusDietary supplement

    Vitamin E

Study groups in NCT03726450
Study groupRoleWhat they receive
Andrositol PlusExperimentalall 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
Receives: Dietary Supplement: Andrositol Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in sperm motility

    spermatozoa motility will be evaluated through microscopical evalutation

    Measured: spermatozoa motility will be analyzed after 3 months of treatment

Secondary outcomes (4)
  1. change in sperm morphology

    spermatozoa morphology will be evaluated through microscopical evalutation

    Measured: 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

    Measured: spermatozoa vitality will be analyzed after 3 months of treatment

  3. change in sperm count

    spermatozoa count will be evaluated through microscopical evalutation

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2018
  2. Study start1 Nov 2018
  3. Primary completion1 Feb 2020 (estimated)
  4. Study completion1 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03726450
Sponsor's protocol ID
MAVIM
Status last verified
Mar 2019
First submitted
7 Sep 2018
Last updated
12 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Andrositol Plus in people with Male Infertility, run by Andrology and Fertility Hospital of Hanoi at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in sperm motility (time frame: spermatozoa motility will be analyzed after 3 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in