To Evaluate the Effect of Reveratrol,Folic Acid, Vitamin D, Vitamin B12 and B6 in Male Infertility

Study Overview
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Brief Summary
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The objective of this study is to evaluate the impact of the Genante(TM) on the spermiogram parameters in infertile male patients

Detailed Description
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This is a single-centre prospective observational study. Twenty infertile male patients. Inclusion criteria are: Age:18-50 years oligozoospermia: < 5 million spermatozoa/mL; asthenozoospermia: < 32% progressive motile spermatozoa; teratozoospermia: < 4% normal forms. Esclusion criteria: Patients with azoospermia, who smoke, use drugs, drugs with proven fertility toxicity, exposed to any environmental or occupational toxic substances, radiation or heat; with orchitis secondary to mumps, sexually transmitted diseases, history of cryptorchidism, previous testicular torsion, genitourinary anomalies, alterations of the epididymis or deferens; and inguinal surgery Pretreatment evaluation included: Semen analysis Hormonal determinations:follicle-stimulating hormone (FSH) and luteinising hormone (LH) total Testosterone Total,estradiol, prolactina, 25-OH-Vitamin D3); scrotal ultrasound prostatic transrectal ultrasound Outocmes measures (baseline, at 1 and 6 months): Semen volume (mL) Total sperm number (106/ejaculate) Sperm concentration (106/mL) Total motility (PR + NP) Progressive motility (PR, %) Vitality (live spermatozoa, %) Sperm morphology (normal forms, %) Ph FSH LH Testosterone totale Estradiol Prolactiona 25-OH-Vitamin D3 scrotal ultrasound prostatic transrectal ultrasound

Official Title
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Evaluation of Treatment With Trans-resveratrol, Folic Acid, Vitamin D, Vitamin B12 and B6 in Men With Infertility

Conditions
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Male Infertility

Intervention / Treatment
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* Dietary Supplement: Genante


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male 18-50 years oligozoospermia: < 5 million spermatozoa/mL; asthenozoospermia: < 32% progressive motile spermatozoa; teratozoospermia: < 4% normal forms. Exclusion Criteria: azoospermia smoke use drugs use drugs with proven fertility toxicity exposition to any environmental or occupational toxic substances exposition to radiation or heat orchitis secondary to mumps sexually transmitted diseases history of cryptorchidism previous testicular torsion genitourinary anomalies alterations of the epididymis or deferens inguinal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Genante (Tm)<br>Genante tablets One tablet in the morning and one tablet in the evening for 3 months | Dietary Supplement: Genante<br>* A dietary supplement for male infertility<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Semen volume at 1 month | semen volume in semen analysis | 1 month | 
| Change from 1month Semen volume at 6 months | semen volume in semen analysis | 6 months | 
| Change from baseline Total sperm number at 1 month | total sperm number in semen analysis | 1 month | 
| Change from 1 month Total sperm number at 6 months | total sperm number in semen analysis | 6 months | 
| Change from baseline Sperm concentration at 1 month | Sperm concentration in semen analysis | 1 month | 
| Change from 1 month Sperm concentration at 6 months | Sperm concentration in semen analysis | 6 months | 
| Change from baseline Total Motility at 1 month | total motility of spermatozoa in semen analysis | 1 month | 
| Change from 1 month Total Motility at 6 months | total motility of spermatozoa in semen analysis | 6 months | 
| Change from baseline Progressive motility at 1 month | Porgressive motility of spermatozoa in semen analysis | 1 month | 
| Change from 1 month Progressive motility at 6 months | Progressive motility of spermatozoa in semen analysis | 6 months | 
| Change from baseline Vitality at 1 month | live spermatozoa | 1 month | 
| Change from 1 month Vitality at 6 months | live spermatozoa | 6 months | 
| Change from baseline Sperm morphology at 1 month | normal forms of spermatozoa | 1 month | 
| Change from 1 month Sperm morphology at 6 months | normal forms of spermatozoa | 6 months | 
| Change from baseline FSH at 1 month | plasmatic evaluation of FSH | 1 month | 
| Change from 1 month FSH at 6 months | plasmatic evaluation of FSH | 6 months | 
| Change from baseline LH at 1 month | Plasmatic evaluation of LH | 1 month | 
| Change from 1 month LH at 6 months | Plasmatic evaluation of LH | 6 months | 
| Change from baseline Total testosterone at 1 month | plasmatic evaluation of total testosterone | 1 month | 
| Change from 1 month Total testosterone at 6 months | plasmatic evaluation of total testosterone | 6 months | 
| Change from baseline Prolactina at 1 month | plasmatic evaluation of prolactina | 1 month | 
| Change from 1 month Prolactina at 6 months | plasmatic evaluation of prolactina | 6 months | 
| Change from baseline 25-OH-Vitamin D3 at 1 month | plasmatic evaluation of 25-OH-Vitamin D3 | 1 month | 
| Change from 1 month 25-OH-Vitamin D3 at 6 months | plasmatic evaluation of 25-OH-Vitamin D3 | 6 months | 
| Change from baseline Scrotal ultrasound at 1 month | testis volume and vas deferens by ultrasound | 1 month | 
| Change from 1 month Scrotal ultrasound at 6 months | testis volume and vas deferens by ultrasound | 6 months | 
| Change from baseline Trans rectal Prostatic ultrasound at 1 month | prostate volume and morphology by ultrasound | 1 month | 
| Change from 1 month Trans rectal Prostatic ultrasound at 6 months | prostate volume and morphology by ultrasound | 6 months | 
| Change from baseline estradiol at 1 month | plasmatic evaluation of esatrdiol | 1 month | 
| Change from 1 month estradiol at 6 months | plasmatic evaluation of esatrdiol | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male infertility, Reveratrol, Vitamin B12, Vitamin B6, Folic acid