NCT03864198

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

March 6, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

February 14, 2019

Last Update Submit

March 3, 2019

Conditions

Male Infertility

Keywords

Male infertilityReveratrolVitamin B12Vitamin B6Folic acid

Outcome Measures

Primary Outcomes (30)

  • Change from Baseline Semen volume at 1 month

    semen volume in semen analysis

    1 month

  • Change from 1month Semen volume at 6 months

    semen volume in semen analysis

    6 months

  • Change from baseline Total sperm number at 1 month

    total sperm number in semen analysis

    1 month

  • Change from 1 month Total sperm number at 6 months

    total sperm number in semen analysis

    6 months

  • Change from baseline Sperm concentration at 1 month

    Sperm concentration in semen analysis

    1 month

  • Change from 1 month Sperm concentration at 6 months

    Sperm concentration in semen analysis

    6 months

  • Change from baseline Total Motility at 1 month

    total motility of spermatozoa in semen analysis

    1 month

  • Change from 1 month Total Motility at 6 months

    total motility of spermatozoa in semen analysis

    6 months

  • Change from baseline Progressive motility at 1 month

    Porgressive motility of spermatozoa in semen analysis

    1 month

  • Change from 1 month Progressive motility at 6 months

    Progressive motility of spermatozoa in semen analysis

    6 months

  • Change from baseline Vitality at 1 month

    live spermatozoa

    1 month

  • Change from 1 month Vitality at 6 months

    live spermatozoa

    6 months

  • Change from baseline Sperm morphology at 1 month

    normal forms of spermatozoa

    1 month

  • Change from 1 month Sperm morphology at 6 months

    normal forms of spermatozoa

    6 months

  • Change from baseline FSH at 1 month

    plasmatic evaluation of FSH

    1 month

  • Change from 1 month FSH at 6 months

    plasmatic evaluation of FSH

    6 months

  • Change from baseline LH at 1 month

    Plasmatic evaluation of LH

    1 month

  • Change from 1 month LH at 6 months

    Plasmatic evaluation of LH

    6 months

  • Change from baseline Total testosterone at 1 month

    plasmatic evaluation of total testosterone

    1 month

  • Change from 1 month Total testosterone at 6 months

    plasmatic evaluation of total testosterone

    6 months

  • Change from baseline Prolactina at 1 month

    plasmatic evaluation of prolactina

    1 month

  • Change from 1 month Prolactina at 6 months

    plasmatic evaluation of prolactina

    6 months

  • Change from baseline 25-OH-Vitamin D3 at 1 month

    plasmatic evaluation of 25-OH-Vitamin D3

    1 month

  • Change from 1 month 25-OH-Vitamin D3 at 6 months

    plasmatic evaluation of 25-OH-Vitamin D3

    6 months

  • Change from baseline Scrotal ultrasound at 1 month

    testis volume and vas deferens by ultrasound

    1 month

  • Change from 1 month Scrotal ultrasound at 6 months

    testis volume and vas deferens by ultrasound

    6 months

  • Change from baseline Trans rectal Prostatic ultrasound at 1 month

    prostate volume and morphology by ultrasound

    1 month

  • Change from 1 month Trans rectal Prostatic ultrasound at 6 months

    prostate volume and morphology by ultrasound

    6 months

  • Change from baseline estradiol at 1 month

    plasmatic evaluation of esatrdiol

    1 month

  • Change from 1 month estradiol at 6 months

    plasmatic evaluation of esatrdiol

    6 months

Study Arms (1)

Genante (Tm)

OTHER

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

Dietary Supplement: Genante

Interventions

GenanteDIETARY_SUPPLEMENT

A dietary supplement for male infertility

Genante (Tm)

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsInfertile man
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male 18-50 years
  • oligozoospermia: \< 5 million spermatozoa/mL;
  • asthenozoospermia: \< 32% progressive motile spermatozoa;
  • teratozoospermia: \< 4% normal forms.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elisabetta Costantini

Terni, 05100, Italy

RECRUITING

Related Publications (14)

  • Agarwal A, Nallella KP, Allamaneni SS, Said TM. Role of antioxidants in treatment of male infertility: an overview of the literature. Reprod Biomed Online. 2004 Jun;8(6):616-27. doi: 10.1016/s1472-6483(10)61641-0.

    PMID: 15169573BACKGROUND

  • Griveau JF, Le Lannou D. Reactive oxygen species and human spermatozoa: physiology and pathology. Int J Androl. 1997 Apr;20(2):61-9. doi: 10.1046/j.1365-2605.1997.00044.x.

    PMID: 9292315BACKGROUND

  • Aitken RJ. Free radicals, lipid peroxidation and sperm function. Reprod Fertil Dev. 1995;7(4):659-68. doi: 10.1071/rd9950659.

    PMID: 8711202BACKGROUND

  • de Lamirande E, Leclerc P, Gagnon C. Capacitation as a regulatory event that primes spermatozoa for the acrosome reaction and fertilization. Mol Hum Reprod. 1997 Mar;3(3):175-94. doi: 10.1093/molehr/3.3.175.

    PMID: 9237244BACKGROUND

  • Hughes CM, Lewis SE, McKelvey-Martin VJ, Thompson W. The effects of antioxidant supplementation during Percoll preparation on human sperm DNA integrity. Hum Reprod. 1998 May;13(5):1240-7. doi: 10.1093/humrep/13.5.1240.

    PMID: 9647554BACKGROUND

  • Erben RG, Soegiarto DW, Weber K, Zeitz U, Lieberherr M, Gniadecki R, Moller G, Adamski J, Balling R. Deletion of deoxyribonucleic acid binding domain of the vitamin D receptor abrogates genomic and nongenomic functions of vitamin D. Mol Endocrinol. 2002 Jul;16(7):1524-37. doi: 10.1210/mend.16.7.0866.

    PMID: 12089348BACKGROUND

  • Hammoud AO, Meikle AW, Peterson CM, Stanford J, Gibson M, Carrell DT. Association of 25-hydroxy-vitamin D levels with semen and hormonal parameters. Asian J Androl. 2012 Nov;14(6):855-9. doi: 10.1038/aja.2012.77. Epub 2012 Oct 8.

    PMID: 23042450BACKGROUND

  • Wong WY, Merkus HM, Thomas CM, Menkveld R, Zielhuis GA, Steegers-Theunissen RP. Effects of folic acid and zinc sulfate on male factor subfertility: a double-blind, randomized, placebo-controlled trial. Fertil Steril. 2002 Mar;77(3):491-8. doi: 10.1016/s0015-0282(01)03229-0.

    PMID: 11872201BACKGROUND

  • Chen Q, Ng V, Mei J, Chia SE. [Comparison of seminal vitamin B12, folate, reactive oxygen species and various sperm parameters between fertile and infertile males]. Wei Sheng Yan Jiu. 2001 Mar;30(2):80-2. Chinese.

    PMID: 11321956BACKGROUND

  • Das S, Lin HS, Ho PC, Ng KY. The impact of aqueous solubility and dose on the pharmacokinetic profiles of resveratrol. Pharm Res. 2008 Nov;25(11):2593-600. doi: 10.1007/s11095-008-9677-1. Epub 2008 Jul 16.

    PMID: 18629618BACKGROUND

  • Amri A, Chaumeil JC, Sfar S, Charrueau C. Administration of resveratrol: What formulation solutions to bioavailability limitations? J Control Release. 2012 Mar 10;158(2):182-93. doi: 10.1016/j.jconrel.2011.09.083. Epub 2011 Sep 25.

    PMID: 21978644BACKGROUND

  • Orihuela-Campos RC, Tamaki N, Mukai R, Fukui M, Miki K, Terao J, Ito HO. Biological impacts of resveratrol, quercetin, and N-acetylcysteine on oxidative stress in human gingival fibroblasts. J Clin Biochem Nutr. 2015 May;56(3):220-7. doi: 10.3164/jcbn.14-129. Epub 2015 Mar 28.

    PMID: 26060353BACKGROUND

  • Liu J, Yi L, Xiang Z, Zhong J, Zhang H, Sun T. Resveratrol attenuates spinal cord injury-induced inflammatory damage in rat lungs. Int J Clin Exp Pathol. 2015 Feb 1;8(2):1237-46. eCollection 2015.

    PMID: 25973008BACKGROUND

  • Illiano E, Trama F, Zucchi A, Iannitti RG, Fioretti B, Costantini E. Resveratrol-Based Multivitamin Supplement Increases Sperm Concentration and Motility in Idiopathic Male Infertility: A Pilot Clinical Study. J Clin Med. 2020 Dec 11;9(12):4017. doi: 10.3390/jcm9124017.

    PMID: 33322606DERIVED

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Ester Illiano, MD

    University Of Perugia

    STUDY DIRECTOR

Central Study Contacts

Elisabetta Costantini, Professor

CONTACT

3283620614elisabetta.costantini@unipg.it

Ester Illiano, MD

CONTACT

3283620614ester.illiano@inwind.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 14, 2019

First Posted

March 6, 2019

Study Start

January 20, 2019

Primary Completion

March 20, 2019

Study Completion

April 30, 2019

Last Updated

March 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)