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| ID | Type | Description | Link |
|---|---|---|---|
| 3310 | Registry Identifier | CEAS |
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| Name | Class |
|---|---|
| Ester Illiano, MD | UNKNOWN |
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The objective of this study is to evaluate the impact of the Genante(TM) on the spermiogram parameters in infertile male patients
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genante (Tm) | Other | Genante tablets One tablet in the morning and one tablet in the evening for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genante | Dietary Supplement | A dietary supplement for male infertility |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Infertile man
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabetta Costantini, Professor | Contact | 3283620614 | elisabetta.costantini@unipg.it | |
| Ester Illiano, MD | Contact | 3283620614 | ester.illiano@inwind.it |
| Name | Affiliation | Role |
|---|---|---|
| Ester Illiano, MD | University Of Perugia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elisabetta Costantini | Recruiting | Terni | 05100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15169573 | Background | 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. | |
| 9292315 | Background | 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. |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| 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 |
| 8711202 | Background | Aitken RJ. Free radicals, lipid peroxidation and sperm function. Reprod Fertil Dev. 1995;7(4):659-68. doi: 10.1071/rd9950659. |
| 9237244 | Background | 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. |
| 9647554 | Background | 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. |
| 12089348 | Background | 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. |
| 23042450 | Background | 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. |
| 11872201 | Background | 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. |
| 11321956 | Background | 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. |
| 18629618 | Background | 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. |
| 21978644 | Background | 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. |
| 26060353 | Background | 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. |
| 25973008 | Background | 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. |
| 33322606 | Derived | 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. |
| D052801 |
| Male Urogenital Diseases |