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

University Of Perugia

Status: Unknown

Conditions: Male Infertility

Treatments: Dietary Supplement: Genante

Study type: Interventional

Funder types: Other

Identifiers

NCT03864198

3310 (Registry Identifier)

RESV1

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Genante (Tm)

Other group

Description:

Genante tablets One tablet in the morning and one tablet in the evening for 3 months

Treatment:

Dietary Supplement: Genante