NCT04291495

Brief Summary

Mitochondria is the cellular organelle responsible for the production of the energy necessary to fuel sperm motility. It has been demonstrated that mitochondrial efficiency is correlated to the fertilizing capacity of the spermatozoon and to the production of high quality embryos. Mitochondria efficiency is measured in the laboratory setting by evaluating the mitochondrial membrane potential. Myo-inositol is the most represented stereoisomer of the family of inositols and is the only one physiologically concentrated within the seminal plasma. It is essential for sperm maturation and motility and its deficiency is also associated to a reduced sperm count. Myo-inositol promotes motility and allows recovering a higher number of sperm cells after swim-up, both in normospermic patients and in patients with altered seminal parameters. Scientific studies have shown that semen samples treated in vitro with ANDROSITOL®DGN, show an improvement in mitochondrial efficiency that results in an increase in spermatozoa progressive motility. Based on the percentage increase in the progressive motility showed by the spermatozoa after incubation with ANDROSITOL®DGN (ANDROSITOL®TEST), it is possible to subdivide the semen samples into three categories: low, medium, and high responders. The aim of the study is to evaluate whether the in vitro response of spermatozoa to ANDROSITOL®TEST correlates with the in vivo improvement of seminal parameters after oral treatment with antioxidants and myo-inositol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

June 10, 2019

Last Update Submit

May 12, 2021

Conditions

AsthenozoospermiaMitochondrial Damage

Keywords

Male infertilitySperm parametersMitochondrial membrane potential

Outcome Measures

Primary Outcomes (2)

  • Response to the ANDROSI-TEST

    Number of poor and high responders to ANDROSI-TEST

    T0 and T1 (three months)

  • Sperm parameters

    Percentage of total and progressive sperm motility and percentage of spermatozoa with high or low mitochondrial membrane potential

    T0 and T1 (three months)

Secondary Outcomes (6)

  • Other Sperm parameters (1)

    T0 and T1 (three months)

  • Other Sperm parameters (2)

    T0 and T1 (three months)

  • Effects after therapy (1)

    T1 (three months) and T2 (six months - three months after supplementation withdrawal)

  • Effects after therapy (2)

    T1 (three months) and T2 (six months - three months after supplementation withdrawal)

  • Effects after therapy (3)

    T1 (three months) and T2 (six months - three months after supplementation withdrawal)

  • +1 more secondary outcomes

Study Arms (1)

ANDROSITOL®TEST

EXPERIMENTAL

At least 45 patients (13 for each category: low, medium, and high responders, + 15% of hypothetical drop-outs)

Diagnostic Test: ANDROSITOL®TEST

Interventions

ANDROSITOL®TESTDIAGNOSTIC_TEST

Sperm incubation with ANDROSITOL®DGN and evaluation of sperm motility and mithocondrial membrane potential

ANDROSITOL®TEST

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • \- Absolute asthenozoospermia
  • Leukocytospermia
  • Positive semen culture and/or urethral swab
  • Human Papilloma Virus (HPV) DNA in semen
  • History of cryptorchidism
  • rd degree varicocele
  • Markedly reduced testicular volume
  • Decompensated diabetes mellitus and other systemic diseases leading to oxidative stress (e.g. chronic renal failure, liver failure)
  • Altered concentrations of the following hormones: luteinizing hormone (LH), follicle stimulating hormone (FSH), total testosterone, prolactin, 17β-estradiol
  • Alcohol and drug abuse
  • Heavy cigarette smoke (≥10 cigarettes/day)
  • Body Mass Index (BMI) \>35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical and Experimental Medicine, University of Catania

Catania, 95123, Italy

Location

Related Publications (11)

  • Calogero AE, Gullo G, La Vignera S, Condorelli RA, Vaiarelli A. Myoinositol improves sperm parameters and serum reproductive hormones in patients with idiopathic infertility: a prospective double-blind randomized placebo-controlled study. Andrology. 2015 May;3(3):491-5. doi: 10.1111/andr.12025. Epub 2015 Apr 9.

    PMID: 25854593BACKGROUND

  • Condorelli RA, La Vignera S, Di Bari F, Unfer V, Calogero AE. Effects of myoinositol on sperm mitochondrial function in-vitro. Eur Rev Med Pharmacol Sci. 2011 Feb;15(2):129-34.

    PMID: 21434479BACKGROUND

  • Condorelli RA, La Vignera S, Bellanca S, Vicari E, Calogero AE. Myoinositol: does it improve sperm mitochondrial function and sperm motility? Urology. 2012 Jun;79(6):1290-5. doi: 10.1016/j.urology.2012.03.005.

    PMID: 22656408BACKGROUND

  • Gulino FA, Leonardi E, Marilli I, Musmeci G, Vitale SG, Leanza V, Palumbo MA. Effect of treatment with myo-inositol on semen parameters of patients undergoing an IVF cycle: in vivo study. Gynecol Endocrinol. 2016;32(1):65-8. doi: 10.3109/09513590.2015.1080680. Epub 2015 Sep 11.

    PMID: 26361940BACKGROUND

  • Agarwal A, Parekh N, Panner Selvam MK, Henkel R, Shah R, Homa ST, Ramasamy R, Ko E, Tremellen K, Esteves S, Majzoub A, Alvarez JG, Gardner DK, Jayasena CN, Ramsay JW, Cho CL, Saleh R, Sakkas D, Hotaling JM, Lundy SD, Vij S, Marmar J, Gosalvez J, Sabanegh E, Park HJ, Zini A, Kavoussi P, Micic S, Smith R, Busetto GM, Bakircioglu ME, Haidl G, Balercia G, Puchalt NG, Ben-Khalifa M, Tadros N, Kirkman-Browne J, Moskovtsev S, Huang X, Borges E, Franken D, Bar-Chama N, Morimoto Y, Tomita K, Srini VS, Ombelet W, Baldi E, Muratori M, Yumura Y, La Vignera S, Kosgi R, Martinez MP, Evenson DP, Zylbersztejn DS, Roque M, Cocuzza M, Vieira M, Ben-Meir A, Orvieto R, Levitas E, Wiser A, Arafa M, Malhotra V, Parekattil SJ, Elbardisi H, Carvalho L, Dada R, Sifer C, Talwar P, Gudeloglu A, Mahmoud AMA, Terras K, Yazbeck C, Nebojsa B, Durairajanayagam D, Mounir A, Kahn LG, Baskaran S, Pai RD, Paoli D, Leisegang K, Moein MR, Malik S, Yaman O, Samanta L, Bayane F, Jindal SK, Kendirci M, Altay B, Perovic D, Harlev A. Male Oxidative Stress Infertility (MOSI): Proposed Terminology and Clinical Practice Guidelines for Management of Idiopathic Male Infertility. World J Mens Health. 2019 Sep;37(3):296-312. doi: 10.5534/wjmh.190055. Epub 2019 May 28.

    PMID: 31081299BACKGROUND

  • Paoli D, Gallo M, Rizzo F, Baldi E, Francavilla S, Lenzi A, Lombardo F, Gandini L. Mitochondrial membrane potential profile and its correlation with increasing sperm motility. Fertil Steril. 2011 Jun;95(7):2315-9. doi: 10.1016/j.fertnstert.2011.03.059. Epub 2011 Apr 20.

    PMID: 21507394BACKGROUND

  • Rubino P, Palini S, Chigioni S, Carlomagno G, Quagliariello A, De Stefani S, Baglioni A, Bulletti C. Improving fertilization rate in ICSI cycles by adding myoinositol to the semen preparation procedures: a prospective, bicentric, randomized trial on sibling oocytes. J Assist Reprod Genet. 2015 Mar;32(3):387-94. doi: 10.1007/s10815-014-0401-2. Epub 2015 Jan 20.

    PMID: 25601322BACKGROUND

  • Marchetti P, Ballot C, Jouy N, Thomas P, Marchetti C. Influence of mitochondrial membrane potential of spermatozoa on in vitro fertilisation outcome. Andrologia. 2012 Apr;44(2):136-41. doi: 10.1111/j.1439-0272.2010.01117.x. Epub 2011 Jun 30.

    PMID: 21714802BACKGROUND

  • Robinson R, Fritz IB. Myoinositol biosynthesis by Sertoli cells, and levels of myoinositol biosynthetic enzymes in testis and epididymis. Can J Biochem. 1979 Jun;57(6):962-7. doi: 10.1139/o79-117.

    PMID: 224990BACKGROUND

  • Hinton BT, White RW, Setchell BP. Concentrations of myo-inositol in the luminal fluid of the mammalian testis and epididymis. J Reprod Fertil. 1980 Mar;58(2):395-9. doi: 10.1530/jrf.0.0580395.

    PMID: 7431272BACKGROUND

  • Colone M, Marelli G, Unfer V, Bozzuto G, Molinari A, Stringaro A. Inositol activity in oligoasthenoteratospermia--an in vitro study. Eur Rev Med Pharmacol Sci. 2010 Oct;14(10):891-6.

    PMID: 21222378BACKGROUND

MeSH Terms

Conditions

AsthenozoospermiaInfertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Aldo E. Calogero, Professor

    University of Catania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2019

First Posted

March 2, 2020

Study Start

October 23, 2018

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)