Male Infertility
Conditions
Keywords
Male infertility, Reveratrol, Vitamin B12, Vitamin B6, Folic acid
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
Interventions
DIETARY_SUPPLEMENTGenante
A dietary supplement for male infertility
Sponsors
Ester Illiano, MD
University Of Perugia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from 1 month LH at 6 months | 6 months | Plasmatic evaluation of LH |
| Change from baseline Total testosterone at 1 month | 1 month | plasmatic evaluation of total testosterone |
| Change from 1 month Total testosterone at 6 months | 6 months | plasmatic evaluation of total testosterone |
| Change from baseline Prolactina at 1 month | 1 month | plasmatic evaluation of prolactina |
| Change from 1 month Prolactina at 6 months | 6 months | plasmatic evaluation of prolactina |
| Change from baseline 25-OH-Vitamin D3 at 1 month | 1 month | plasmatic evaluation of 25-OH-Vitamin D3 |
| 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 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 baseline Vitality at 1 month | 1 month | live spermatozoa |
| Change from 1 month Vitality at 6 months | 6 months | live spermatozoa |
| 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 LH at 1 month | 1 month | Plasmatic evaluation of LH |
| 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 baseline Trans rectal Prostatic ultrasound at 1 month | 1 month | prostate volume and morphology by ultrasound |
| Change from 1 month Trans rectal Prostatic ultrasound at 6 months | 6 months | prostate volume and morphology by ultrasound |
| Change from baseline estradiol at 1 month | 1 month | plasmatic evaluation of esatrdiol |
| Change from 1 month estradiol at 6 months | 6 months | plasmatic evaluation of esatrdiol |
Countries
Italy
Contacts
Primary ContactElisabetta Costantini, Professor
Backup ContactEster Illiano, MD
Outcome results
None listed