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

Not Applicable

• Conditions: Male Infertility
• Interventions: Dietary Supplement: Genante

• Registration Number: NCT03864198
• Lead Sponsor: University Of Perugia

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2019-01-20
• Status Verified: 2019-02
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-03-03
• Last Update Submitted: 2019-03-03
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06
• Primary Completion: 2019-03-20
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genante (Tm)	Genante	Genante tablets One tablet in the morning and one tablet in the evening for 3 months

Primary Outcome Measures

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

Trial Locations

Locations (1)

Elisabetta Costantini; 🇮🇹 Terni, Italy