To Evaluate the Effect of Reveratrol,Folic Acid, Vitamin D, Vitamin B12 and B6 in Male Infertility
NCT ID: NCT03864198
Last Updated: 2019-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-01-20
2019-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Genante (Tm)
Genante tablets One tablet in the morning and one tablet in the evening for 3 months
Genante
A dietary supplement for male infertility
Interventions
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Genante
A dietary supplement for male infertility
Eligibility Criteria
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Inclusion Criteria
* oligozoospermia: \< 5 million spermatozoa/mL;
* asthenozoospermia: \< 32% progressive motile spermatozoa;
* teratozoospermia: \< 4% normal forms.
Exclusion Criteria
* 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
18 Years
50 Years
MALE
No
Sponsors
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Ester Illiano, MD
UNKNOWN
University Of Perugia
OTHER
Responsible Party
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Elisabetta Costantini
Clinical Professor
Principal Investigators
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Ester Illiano, MD
Role: STUDY_DIRECTOR
University Of Perugia
Locations
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Elisabetta Costantini
Terni, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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3310
Identifier Type: REGISTRY
Identifier Source: secondary_id
RESV1
Identifier Type: -
Identifier Source: org_study_id
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