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

• ClinicalTrials.gov Identifier: NCT03726450
• Recruitment Status: Unknown
• First Posted: October 31, 2018
• Last Update Posted: December 12, 2019
• Sponsor: Andrology and Fertility Hospital of Hanoi
• Information provided by (Responsible Party): Hung Nguyen Ba, Andrology and Fertility Hospital of Hanoi

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 55 participants
• Allocation: N/A
• 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?
• Actual Study Start Date: November 1, 2018
• Estimated Primary Completion Date: February 1, 2020
• Estimated Study Completion Date: March 1, 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• Responsible Party: Hung Nguyen Ba, Andrologist, Andrology and Fertility Hospital of Hanoi
• ClinicalTrials.gov Identifier: NCT03726450
• Other Study ID Numbers: MAVIM
• First Posted: October 31, 2018
• Last Update Posted: December 12, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Infertility; Infertility, Male