Status unknownNCT03864198Updated Mar 6, 2019

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

An interventional study of Genante in Male Infertility, sponsored by University Of Perugia. Status unknown at 1 site in Italy. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-03-06.

Sponsored by University Of Perugia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years to 50 Years
Sex: Male

Study summary

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

Read the 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

Conditions studied

Male Infertility

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Keywords

Male infertility
Reveratrol
Vitamin B12
Vitamin B6
Folic acid

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

University Of Perugia is the lead sponsor of 51 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: 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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Other
Genante (Tm)
Genante tablets One tablet in the morning and one tablet in the evening for 3 months
Dietary Supplement: Genante

Interventions

Dietary supplementGenante
A dietary supplement for male infertility

What researchers measure

Primary outcomes

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

Study locations

1 of 1 sites recruiting

Elisabetta Costantini
Terni, 05100, Italy
- Elisabetta Costantini, Professor · Contact · elisabetta.costantini@unipg.it · 3283620614
- Ester Illiano, MD · Contact · ester.illiano@inwind.it · 3283620614
- Ester Illiano, MD · Sub investigator
- Elisabetta Costantini, Professor · Principal investigator
Recruiting

References and documents

Publications

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. PubMed 15169573 ↗
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. PubMed 9292315 ↗
Aitken RJ. Free radicals, lipid peroxidation and sperm function. Reprod Fertil Dev. 1995;7(4):659-68. doi: 10.1071/rd9950659. PubMed 8711202 ↗
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. PubMed 9237244 ↗
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. Erratum In: Hum Reprod 1998 Nov;13(11):3284. PubMed 9647554 ↗
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. PubMed 12089348 ↗
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. PubMed 23042450 ↗
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. PubMed 11872201 ↗
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. PubMed 11321956 ↗
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. Erratum In: Pharm Res. 2008 Dec;25(12):2983. PubMed 18629618 ↗
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. PubMed 21978644 ↗
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. PubMed 26060353 ↗
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. PubMed 25973008 ↗
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. PubMed 33322606 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03864198
Lead sponsor: University Of Perugia
Collaborators: Ester Illiano, MD
Responsible party: Elisabetta Costantini (Clinical Professor, University Of Perugia) — Principal investigator
First posted: Mar 6, 2019
Start date: Jan 20, 2019
Primary completion: Mar 20, 2019 (estimated)
Completion: Apr 30, 2019 (estimated)
Last update: Mar 6, 2019

Study contacts

Elisabetta Costantini, Professor

Contact

elisabetta.costantini@unipg.it

3283620614

Ester Illiano, MD

Contact

ester.illiano@inwind.it

3283620614

Ester Illiano, MD

study director · University Of Perugia

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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