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

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ClinicalTrials.gov Identifier: NCT03864198

Recruitment Status : Unknown

Verified February 2019 by Elisabetta Costantini, University Of Perugia.
Recruitment status was: Recruiting

First Posted : March 6, 2019

Last Update Posted : March 6, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Ester Illiano, MD

Information provided by (Responsible Party):

Elisabetta Costantini, University Of Perugia

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
Male Infertility	Dietary Supplement: Genante	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	January 20, 2019
Estimated Primary Completion Date :	March 20, 2019
Estimated Study Completion Date :	April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Sensorineural deafness and male infertility Y chromosome infertility CATSPER1-related nonsyndromic male infertility

MedlinePlus related topics: B Vitamins Folic Acid Infertility Male Infertility Vitamin D

Drug Information available for: Folic acid

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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 :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Male
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Infertile man
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864198

Contacts

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Contact: Elisabetta Costantini, Professor	3283620614	elisabetta.costantini@unipg.it
Contact: Ester Illiano, MD	3283620614	ester.illiano@inwind.it

Locations

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

Sponsors and Collaborators

University Of Perugia

Ester Illiano, MD

Investigators

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Study Director:	Ester Illiano, MD	University Of Perugia

More Information

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Elisabetta Costantini, Clinical Professor, University Of Perugia
ClinicalTrials.gov Identifier:	NCT03864198
Other Study ID Numbers:	RESV1 3310 ( Registry Identifier: CEAS )
First Posted:	March 6, 2019 Key Record Dates
Last Update Posted:	March 6, 2019
Last Verified:	February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Elisabetta Costantini, University Of Perugia:


Male infertility Reveratrol Vitamin B12 Vitamin B6 Folic acid

Additional relevant MeSH terms:

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Infertility Infertility, Male

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