Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
NCT ID: NCT05135143
Last Updated: 2021-11-30
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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COMPLETED
PHASE4
211 participants
INTERVENTIONAL
2017-09-01
2021-01-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
Antioxidant formula
Administration of antioxidant formula 3 times a day and once daily.
Control group
Placebo treatment and control and comparative variables will be measured.
Antioxidant formula
Administration of antioxidant formula 3 times a day and once daily.
Interventions
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Antioxidant formula
Administration of antioxidant formula 3 times a day and once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
45 Years
MALE
No
Sponsors
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University of Tetova, Faculty of Medical Sciences
UNKNOWN
University of Tetova
OTHER
Responsible Party
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Vegim Zhaku
Medical Doctor and Teaching assistant
Principal Investigators
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Vegim Zhaku, MD, PhDc
Role: PRINCIPAL_INVESTIGATOR
University of Tetova
Sheqibe Beadini, PhD
Role: STUDY_CHAIR
University of Tetova
Nexhbedin Beadini, PhD
Role: STUDY_CHAIR
Univeristy of Tetova
Locations
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Univeristy of Tetova
Tetovo, , North Macedonia
Countries
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References
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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
Related Links
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Male infertility, Oxidative Stress and Antioxidants
ROLE OF ANTIOXIDANTS IN THE DIMINUTION OF OXIDATIVE STRESS AND AMELIORATION OF SEMEN PARAMETERS IN IDIOPATHIC MALE INFERTILITY
COMBINATION OF MACA, KOREAN GINSENG EXTRACT AND ANTIOXIDANT THERAPY FOR MALE WITH OLIGOASTHENOZOOSPERMIA: CASE STUDY
Oral antioxidants improve sperm motility, sperm concentration and reduce oxidative stress in males with oligoasthenozoospermia
Other Identifiers
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22-63/3
Identifier Type: -
Identifier Source: org_study_id