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

University Of Perugia20 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Male Infertility

Interventions

GenanteDIETARY_SUPPLEMENT

A dietary supplement for male infertility

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Elisabetta Costantini

Terni, Italy

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline Semen volume at 1 month

semen volume in semen analysis

Time frame: 1 month

Change from 1month Semen volume at 6 months

semen volume in semen analysis

Time frame: 6 months

Change from baseline Total sperm number at 1 month

total sperm number in semen analysis

Time frame: 1 month

Change from 1 month Total sperm number at 6 months

total sperm number in semen analysis

Time frame: 6 months

Change from baseline Sperm concentration at 1 month

Sperm concentration in semen analysis

Time frame: 1 month

Change from 1 month Sperm concentration at 6 months

Sperm concentration in semen analysis

Time frame: 6 months

Change from baseline Total Motility at 1 month

total motility of spermatozoa in semen analysis

Time frame: 1 month

Change from 1 month Total Motility at 6 months

total motility of spermatozoa in semen analysis

Time frame: 6 months

Change from baseline Progressive motility at 1 month

Porgressive motility of spermatozoa in semen analysis

Time frame: 1 month

Central Contacts

Elisabetta Costantini, Professor

CONTACT

3283620614 elisabetta.costantini@unipg.it

Ester Illiano, MD

CONTACT

3283620614 ester.illiano@inwind.it

Data from ClinicalTrials.gov

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