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Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients (OAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05135143
Recruitment Status : Completed
First Posted : November 26, 2021
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
University of Tetova, Faculty of Medical Sciences
Information provided by (Responsible Party):
Vegim Zhaku, University of Tetova

Brief Summary:

Numerous studies verify that the majority of cases of male infertility belong to the group diagnosed with oligoasthenoteratozoospermia (OAT), which means a decrease in the number of sperm in the ejaculate to 15 million / ml, reduced sperm motility of the spermatozoa and morphological disorders of the neck or tail of the sperm.

Genuine scientific studies can not pinpoint the cause of these changes, however, recent advances in science shed light on this issue by confirming the reason, which is as a result of the action of free radicals - oxidative stress.


Condition or disease Intervention/treatment Phase
Infertility Oligoasthenozoospermia Male Combination Product: Antioxidant formula Phase 4

Detailed Description:

The enlightenment project in the field of male infertility in North Macedonia will include a wide team of: students, general practitioners, assistants, professors of pre-clinical subjects, professors and specialists in the field of gynecology, urology and andrologists. The involvement of such a large number of professionals once again verifies the seriousness and determination that this scientific project has.

Investigators hope to contribute generously to:

  1. Identifying new cases and taking measures early, in order to overcome fertilization problems;
  2. For the first time in North Macedonia there will be a more accurate picture of the prevalence of male infertility;
  3. Expanding current scientific knowledge about the role of oxidative stress, its laboratory evaluation, and the impact of antioxidant supplements;
  4. Standardization of doses and type of antioxidant supplements that will be used during the realization of this dissertation and evaluation of their clinical effect in men with OAT;
  5. After the implementation of antioxidant therapy, investigators expect that the results of live births and spontaneous pregnancies will increase, while the number of miscarriages will decrease;
  6. Acquisition of knowledge on laboratory and clinical evaluation techniques of infertile men, which would later lead to the establishment of an andrological laboratory. Investigators anticipate this laboratory to function within the Faculty of Medical Sciences, where all procedures will be performed, from diagnosis to the operation of assisted reproduction techniques (TRA). This, in addition to the material benefit for the benefit of the University of Tetova, also has a benefit in terms of staff, which will be professionalized and trained during the realization of this dissertation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Infertility male patients
Infertile male patients will receive the antioxidant formula for more than 172 days. Divided in two groups. One will take the active substance, to the other group placebo treatment will be given.
Combination Product: Antioxidant formula
Administration of antioxidant formula 3 times a day and once daily.

Placebo Comparator: Control group
Placebo treatment and control and comparative variables will be measured.
Combination Product: Antioxidant formula
Administration of antioxidant formula 3 times a day and once daily.




Primary Outcome Measures :
  1. Sperm parameters [ Time Frame: 6 months ]
    Concentration (10x6 ml)

  2. Sperm parameters [ Time Frame: 6 months ]
    Morphology (percentage)

  3. Sperm parameters [ Time Frame: 6 months ]
    Motility (percentage)


Secondary Outcome Measures :
  1. oxidative stress parameters [ Time Frame: 6 months ]
    MDA (mg/ml)

  2. oxidative stress parameters [ Time Frame: 6 months ]
    Caspase 3 (IU/ml)

  3. oxidative stress parameters [ Time Frame: 6 months ]
    TAC (IU/ml)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Because investigators have to measure sperm parameters
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age, 19-45 years;
  • infertility, 2 years;
  • regular sexual intercourse with a fertile female.
  • The female partner was defined as being fertile if she had undergone a negative infertility workup (biphasic basal body temperature, P evaluation in luteal phase, ultrasound ovary and uterus evaluation, and hysterosalpingogram to study tubal patency)

Exclusion Criteria:

  • use of antioxidant agents or vitamins within 8 weeks prior to inclusion in the study,
  • a history of excessive consumption of alcohol 40 days prior to the start of the trial,
  • patients that showed lower than 5% motility and less than 1 × 106/ml sperm concentration, - patients with any acute or chronic disease or
  • who are undergoing some kind of treatment with any class of drugs and
  • subjects with known hypersensitivity to ingredients in the antioxidant formula.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135143


Locations
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North Macedonia
Univeristy of Tetova
Tetovo, North Macedonia, 6338
Sponsors and Collaborators
University of Tetova
University of Tetova, Faculty of Medical Sciences
Investigators
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Principal Investigator: Vegim Zhaku, MD, PhDc University of Tetova
Study Chair: Sheqibe Beadini, PhD University of Tetova
Study Chair: Nexhbedin Beadini, PhD Univeristy of Tetova
Additional Information:
Publications:
Vegim Zhaku, Ashok Agarwal, Sheqibe Beadini, Ralf Henkel, Renata Finelli, Nexhbedin Beadini and Sava Micic (June 8th 2021). Male Infertility, Oxidative Stress and Antioxidants, Vitamin E in Health and Disease - Interactions, Diseases and Health Aspects, Pınar Erkekoglu and Júlia Scherer Santos, IntechOpen, DOI: 10.5772/intechopen.98204. Available from: https://www.intechopen.com/chapters/77097
] Zhaku V, Beadini Sh, Beadini N, Xhaferi V, Golaboska J. The role of semen analysis in the expression of male infertility in southwestern part of North Macedonia (Experiences from 7 municipalities). UNIVERSI-International Journal of Education Science Technology Innovation Health and Enviroment. 2019;5(2):96-104.
Zhaku V, Beadini Sh, Beadini N, Murtezani B. Combination of Maca, Korean ginseng extract and antioxidant therapy for male with oligoasthenozoospermia: case study. Journal of Hygienic Engineering and Design. 2019; 26(1):28-35.
Zhaku V, Beadini Sh, Beadini N, Xhaferi V. Role of antioxidants in the diminution of oxidative stress and amelioration of semen parameters in idiopathic male infertility. Acta Medica Balkanica. 2020; 5(9-10):69-80.
Zhaku V, Beadini Sh, Beadini N, Xhaferi V, Milenkovic T. Oral antioxidants improve sperm motility, sperm concentration and reduce oxidative stress in males with oligo-asthenozoospermia. In: 22nd European Congress of Endocrinology; 5-9 September 2020; Prague, Czech Republic: Endocrine Abstracts (2020) 70 EP581. DOI:10.1530/ endoabs.70.EP581

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Responsible Party: Vegim Zhaku, Medical Doctor and Teaching assistant, University of Tetova
ClinicalTrials.gov Identifier: NCT05135143    
Other Study ID Numbers: 22-63/3
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Sperm parameters before and after treatment. OS parameters before and after treatment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vegim Zhaku, University of Tetova:
antioxidant
oxidative stress
sperm parameters
Malonedialdehyde
total antioxidant capacity
Additional relevant MeSH terms:
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Infertility
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs