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.
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
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- 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
- Recruiting
Hung Nguyen
Hanoi
Hung three Nguyen, Medical doctor, +84 989 200 940, hung2779@gmail.com
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.
- Conditions
- Male Infertility
- 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 group | Role | What they receive |
|---|---|---|
| Andrositol Plus | Experimental | 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 Receives: Dietary Supplement: Andrositol Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
change in sperm count
spermatozoa count will be evaluated through microscopical evalutation
Measured: spermatozoa count will be 3 months of treatment
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.
- First posted31 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Andrology and Fertility Hospital of Hanoi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung Nguyen Ba, Andrology and Fertility Hospital of Hanoi
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03726450
- Acronym / sponsor ID
- MAVIM
- Conditions
- Male Infertility
- Keywords
- myo-inositol, N-acetyl-cysteine, semen hyperviscosity, idiopathic male infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Andrology and Fertility Hospital of HanoiUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Andrositol Plus | Experimental | Dietary Supplement: Andrositol Plusall 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andrositol PlusMyo-inositol | Dietary supplement | Andrositol Plus |
| Andrositol PlusN-Acetyl-Cysteine | Dietary supplement | Andrositol Plus |
| Andrositol PlusFolic Acid | Dietary supplement | Andrositol Plus |
| Andrositol PlusSelenium | Dietary supplement | Andrositol Plus |
| Andrositol PlusL-arginine | Dietary supplement | Andrositol Plus |
| Andrositol PlusL-carnitine | Dietary supplement | Andrositol Plus |
| Andrositol PlusVitamin E | Dietary supplement | Andrositol Plus |
Primary outcome
change in sperm motility
Time frame: spermatozoa motility will be analyzed after 3 months of treatment
spermatozoa motility will be evaluated through microscopical evalutation
4 secondary outcomes
change in sperm morphology
Time frame: spermatozoa morphology will be analyzed at the enrollment and after 3 months of treatmentanalyzed
change in sperm vitality
Time frame: spermatozoa vitality will be analyzed after 3 months of treatment
change in sperm count
Time frame: spermatozoa count will be 3 months of treatment
change in seminal fluid viscosity
Time frame: semen Hyper-viscosity will be analyzed after 3 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.