Clinical trial NCT03864198: To Evaluate the Effect of Reveratrol,Folic Acid, Vitamin D, Vitamin B12 and B6 in Male Infertility
Official title: Evaluation of Treatment With Trans-resveratrol, Folic Acid, Vitamin D, Vitamin B12 and B6 in Men With Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Male Infertility
Keywords: Male infertility
Reveratrol
Vitamin B12
Vitamin B6
Folic acid
Lead sponsor: University Of Perugia
Sponsor class: OTHER
Collaborators: name: Ester Illiano, MD
First posted: 2019-03-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Semen volume at 1 month
timeFrame: 1 month
measure: Change from 1month Semen volume at 6 months
timeFrame: 6 months
measure: Change from baseline Total sperm number at 1 month
timeFrame: 1 month
measure: Change from 1 month Total sperm number at 6 months
timeFrame: 6 months
measure: Change from baseline Sperm concentration at 1 month
timeFrame: 1 month
measure: Change from 1 month Sperm concentration at 6 months
timeFrame: 6 months
measure: Change from baseline Total Motility at 1 month
timeFrame: 1 month
measure: Change from 1 month Total Motility at 6 months
timeFrame: 6 months
measure: Change from baseline Progressive motility at 1 month
timeFrame: 1 month
measure: Change from 1 month Progressive motility at 6 months
timeFrame: 6 months
measure: Change from baseline Vitality at 1 month
timeFrame: 1 month
measure: Change from 1 month Vitality at 6 months
timeFrame: 6 months
measure: Change from baseline Sperm morphology at 1 month
timeFrame: 1 month
measure: Change from 1 month Sperm morphology at 6 months
timeFrame: 6 months
measure: Change from baseline FSH at 1 month
timeFrame: 1 month
measure: Change from 1 month FSH at 6 months
timeFrame: 6 months
measure: Change from baseline LH at 1 month
timeFrame: 1 month
measure: Change from 1 month LH at 6 months
timeFrame: 6 months
measure: Change from baseline Total testosterone at 1 month
timeFrame: 1 month
measure: Change from 1 month Total testosterone at 6 months
timeFrame: 6 months
measure: Change from baseline Prolactina at 1 month
timeFrame: 1 month
measure: Change from 1 month Prolactina at 6 months
timeFrame: 6 months
measure: Change from baseline 25-OH-Vitamin D3 at 1 month
timeFrame: 1 month
measure: Change from 1 month 25-OH-Vitamin D3 at 6 months
timeFrame: 6 months
measure: Change from baseline Scrotal ultrasound at 1 month
timeFrame: 1 month
measure: Change from 1 month Scrotal ultrasound at 6 months
timeFrame: 6 months
measure: Change from baseline Trans rectal Prostatic ultrasound at 1 month
timeFrame: 1 month
measure: Change from 1 month Trans rectal Prostatic ultrasound at 6 months
timeFrame: 6 months
measure: Change from baseline estradiol at 1 month
timeFrame: 1 month
measure: Change from 1 month estradiol at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Terni
country: Italy
facility: Elisabetta Costantini
Study officials:
affiliation: University Of Perugia
name: Ester Illiano, MD
role: STUDY_DIRECTOR
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