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

Sponsor
University Of Perugia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03864198
Collaborator
Ester Illiano, MD (Other)
20
Enrollment
1
Location
1
Arm
3.3
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Genante
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Treatment With Trans-resveratrol, Folic Acid, Vitamin D, Vitamin B12 and B6 in Men With Infertility
Actual Study Start Date :
Jan 20, 2019
Anticipated Primary Completion Date :
Mar 20, 2019
Anticipated Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Genante (Tm)

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

Dietary Supplement: Genante
A dietary supplement for male infertility

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Semen volume at 1 month [1 month]

    semen volume in semen analysis

  2. Change from 1month Semen volume at 6 months [6 months]

    semen volume in semen analysis

  3. Change from baseline Total sperm number at 1 month [1 month]

    total sperm number in semen analysis

  4. Change from 1 month Total sperm number at 6 months [6 months]

    total sperm number in semen analysis

  5. Change from baseline Sperm concentration at 1 month [1 month]

    Sperm concentration in semen analysis

  6. Change from 1 month Sperm concentration at 6 months [6 months]

    Sperm concentration in semen analysis

  7. Change from baseline Total Motility at 1 month [1 month]

    total motility of spermatozoa in semen analysis

  8. Change from 1 month Total Motility at 6 months [6 months]

    total motility of spermatozoa in semen analysis

  9. Change from baseline Progressive motility at 1 month [1 month]

    Porgressive motility of spermatozoa in semen analysis

  10. Change from 1 month Progressive motility at 6 months [6 months]

    Progressive motility of spermatozoa in semen analysis

  11. Change from baseline Vitality at 1 month [1 month]

    live spermatozoa

  12. Change from 1 month Vitality at 6 months [6 months]

    live spermatozoa

  13. Change from baseline Sperm morphology at 1 month [1 month]

    normal forms of spermatozoa

  14. Change from 1 month Sperm morphology at 6 months [6 months]

    normal forms of spermatozoa

  15. Change from baseline FSH at 1 month [1 month]

    plasmatic evaluation of FSH

  16. Change from 1 month FSH at 6 months [6 months]

    plasmatic evaluation of FSH

  17. Change from baseline LH at 1 month [1 month]

    Plasmatic evaluation of LH

  18. Change from 1 month LH at 6 months [6 months]

    Plasmatic evaluation of LH

  19. Change from baseline Total testosterone at 1 month [1 month]

    plasmatic evaluation of total testosterone

  20. Change from 1 month Total testosterone at 6 months [6 months]

    plasmatic evaluation of total testosterone

  21. Change from baseline Prolactina at 1 month [1 month]

    plasmatic evaluation of prolactina

  22. Change from 1 month Prolactina at 6 months [6 months]

    plasmatic evaluation of prolactina

  23. Change from baseline 25-OH-Vitamin D3 at 1 month [1 month]

    plasmatic evaluation of 25-OH-Vitamin D3

  24. Change from 1 month 25-OH-Vitamin D3 at 6 months [6 months]

    plasmatic evaluation of 25-OH-Vitamin D3

  25. Change from baseline Scrotal ultrasound at 1 month [1 month]

    testis volume and vas deferens by ultrasound

  26. Change from 1 month Scrotal ultrasound at 6 months [6 months]

    testis volume and vas deferens by ultrasound

  27. Change from baseline Trans rectal Prostatic ultrasound at 1 month [1 month]

    prostate volume and morphology by ultrasound

  28. Change from 1 month Trans rectal Prostatic ultrasound at 6 months [6 months]

    prostate volume and morphology by ultrasound

  29. Change from baseline estradiol at 1 month [1 month]

    plasmatic evaluation of esatrdiol

  30. Change from 1 month estradiol at 6 months [6 months]

    plasmatic evaluation of esatrdiol

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Elisabetta Costantini Terni Italy 05100

Sponsors and Collaborators

  • University Of Perugia
  • Ester Illiano, MD

Investigators

  • Study Director: Ester Illiano, MD, University Of Perugia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elisabetta Costantini, Clinical Professor, University Of Perugia
ClinicalTrials.gov Identifier:
NCT03864198
Other Study ID Numbers:
  • RESV1
  • 3310
First Posted:
Mar 6, 2019
Last Update Posted:
Mar 6, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elisabetta Costantini, Clinical Professor, University Of Perugia
Male infertility
Reveratrol
Vitamin B12
Vitamin B6
Folic acid
Additional relevant MeSH terms:
Infertility
Infertility, Male

Study Results

No Results Posted as of Mar 6, 2019