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

Male Infertility Clinical Trial

Official title:

Evaluation of Treatment With Trans-resveratrol, Folic Acid, Vitamin D, Vitamin B12 and B6 in Men With Infertility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864198
• Other study ID #: RESV1
• Secondary ID: 3310
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2019
• Source: University Of Perugia
• Contact: Elisabetta Costantini, Professor
• Phone: 3283620614
• Email: elisabetta.costantini[@]unipg.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Dietary Supplement:
• Genante
A dietary supplement for male infertility

Locations

Country	Name	City	State
Italy	Elisabetta Costantini	Terni

Sponsors (2)

Lead Sponsor	Collaborator
University Of Perugia	Ester Illiano, MD

Country where clinical trial is conducted

Italy, 

References & Publications (13)

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. Review. — View Citation

Aitken RJ. Free radicals, lipid peroxidation and sperm function. Reprod Fertil Dev. 1995;7(4):659-68. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Erben RG, Soegiarto DW, Weber K, Zeitz U, Lieberherr M, Gniadecki R, Möller 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. — View Citation

Griveau JF, Le Lannou D. Reactive oxygen species and human spermatozoa: physiology and pathology. Int J Androl. 1997 Apr;20(2):61-9. Review. — View Citation

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. — View Citation

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. Erratum in: Hum Reprod 1998 Nov;13(11):3284. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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