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Male InfertilityNCT03864198

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

A study testing Genante in people with Male Infertility, run by University Of Perugia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 50 years, men only
Conditions the study is for
Male Infertility
What is being tested?
Genante
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
20 Jan 2019to 30 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • male 18-50 years
  • oligozoospermia: < 5 million spermatozoa/mL;
  • asthenozoospermia: < 32% progressive motile spermatozoa;
  • teratozoospermia: < 4% normal forms.

Who cannot join

  • azoospermia
  • smoke
  • use drugs
  • use drugs with proven fertility toxicity
  • exposition to any environmental or occupational toxic substances
  • exposition to radiation or heat
Show all 13Show fewer
  • orchitis secondary to mumps
  • sexually transmitted diseases
  • history of cryptorchidism
  • previous testicular torsion
  • genitourinary anomalies
  • alterations of the epididymis or deferens
  • inguinal surgery

Trial locations and contacts

1 site in 1 country.

Elisabetta Costantini, Professor contact

3283620614

elisabetta.costantini@unipg.it

Ester Illiano, MD contact

3283620614

ester.illiano@inwind.it

Italy1 site, 1 recruiting

  • Elisabetta Costantini

    Terni, 05100

    Elisabetta Costantini, Professor, 3283620614, elisabetta.costantini@unipg.it

    Ester Illiano, MD, 3283620614, ester.illiano@inwind.it

    Recruiting

Other trials in Italy

About this study

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

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
Being tested
Genante
Keywords
Male infertility, Reveratrol, Vitamin B12, Vitamin B6, Folic acid
Medical subject headings
Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GenanteDietary supplement

    A dietary supplement for male infertility

Study groups in NCT03864198
Study groupRoleWhat they receive
Genante (Tm)OtherGenante tablets One tablet in the morning and one tablet in the evening for 3 months
Receives: Dietary Supplement: Genante

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Semen volume at 1 month

    semen volume in semen analysis

    Measured: 1 month

  2. Change from 1month Semen volume at 6 months

    semen volume in semen analysis

    Measured: 6 months

  3. Change from baseline Total sperm number at 1 month

    total sperm number in semen analysis

    Measured: 1 month

  4. Change from 1 month Total sperm number at 6 months

    total sperm number in semen analysis

    Measured: 6 months

  5. Change from baseline Sperm concentration at 1 month

    Sperm concentration in semen analysis

    Measured: 1 month

  6. Change from 1 month Sperm concentration at 6 months

    Sperm concentration in semen analysis

    Measured: 6 months

  7. Change from baseline Total Motility at 1 month

    total motility of spermatozoa in semen analysis

    Measured: 1 month

  8. Change from 1 month Total Motility at 6 months

    total motility of spermatozoa in semen analysis

    Measured: 6 months

  9. Change from baseline Progressive motility at 1 month

    Porgressive motility of spermatozoa in semen analysis

    Measured: 1 month

  10. Change from 1 month Progressive motility at 6 months

    Progressive motility of spermatozoa in semen analysis

    Measured: 6 months

  11. Change from baseline Vitality at 1 month

    live spermatozoa

    Measured: 1 month

  12. Change from 1 month Vitality at 6 months

    live spermatozoa

    Measured: 6 months

  13. Change from baseline Sperm morphology at 1 month

    normal forms of spermatozoa

    Measured: 1 month

  14. Change from 1 month Sperm morphology at 6 months

    normal forms of spermatozoa

    Measured: 6 months

  15. Change from baseline FSH at 1 month

    plasmatic evaluation of FSH

    Measured: 1 month

  16. Change from 1 month FSH at 6 months

    plasmatic evaluation of FSH

    Measured: 6 months

  17. Change from baseline LH at 1 month

    Plasmatic evaluation of LH

    Measured: 1 month

  18. Change from 1 month LH at 6 months

    Plasmatic evaluation of LH

    Measured: 6 months

  19. Change from baseline Total testosterone at 1 month

    plasmatic evaluation of total testosterone

    Measured: 1 month

  20. Change from 1 month Total testosterone at 6 months

    plasmatic evaluation of total testosterone

    Measured: 6 months

  21. Change from baseline Prolactina at 1 month

    plasmatic evaluation of prolactina

    Measured: 1 month

  22. Change from 1 month Prolactina at 6 months

    plasmatic evaluation of prolactina

    Measured: 6 months

  23. Change from baseline 25-OH-Vitamin D3 at 1 month

    plasmatic evaluation of 25-OH-Vitamin D3

    Measured: 1 month

  24. Change from 1 month 25-OH-Vitamin D3 at 6 months

    plasmatic evaluation of 25-OH-Vitamin D3

    Measured: 6 months

  25. Change from baseline Scrotal ultrasound at 1 month

    testis volume and vas deferens by ultrasound

    Measured: 1 month

  26. Change from 1 month Scrotal ultrasound at 6 months

    testis volume and vas deferens by ultrasound

    Measured: 6 months

  27. Change from baseline Trans rectal Prostatic ultrasound at 1 month

    prostate volume and morphology by ultrasound

    Measured: 1 month

  28. Change from 1 month Trans rectal Prostatic ultrasound at 6 months

    prostate volume and morphology by ultrasound

    Measured: 6 months

  29. Change from baseline estradiol at 1 month

    plasmatic evaluation of esatrdiol

    Measured: 1 month

  30. Change from 1 month estradiol at 6 months

    plasmatic evaluation of esatrdiol

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2019
  2. Study start20 Jan 2019
  3. Primary completion20 Mar 2019 (estimated)
  4. Study completion30 Apr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03864198
Sponsor's protocol ID
RESV1
Other IDs
3310
Status last verified
Feb 2019
First submitted
14 Feb 2019
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Genante in people with Male Infertility, run by University Of Perugia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elisabetta Costantini, Professor (3283620614, elisabetta.costantini@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Semen volume at 1 month (time frame: 1 month). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03864198, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.

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