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

Last updated: March 3, 2019
Sponsor: University Of Perugia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Men's Health

Infertility

Hypogonadism

Treatment

N/A

Clinical Study ID

NCT03864198
RESV1
3310
  • Ages 18-50
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male 18-50 years

  • oligozoospermia: < 5 million spermatozoa/mL;

  • asthenozoospermia: < 32% progressive motile spermatozoa;

  • teratozoospermia: < 4% normal forms.

Exclusion

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

Study Design

Total Participants: 20
Study Start date:
January 20, 2019
Estimated Completion Date:
April 30, 2019

Study Description

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

Connect with a study center

  • Elisabetta Costantini

    Terni, 05100
    Italy

    Active - Recruiting

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