Clinical trial NCT05135143: Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
Official title: Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Oligoasthenozoospermia
Male
Keywords: antioxidant
oxidative stress
sperm parameters
Malonedialdehyde
total antioxidant capacity
Lead sponsor: University of Tetova
Sponsor class: OTHER
Collaborators: name: University of Tetova, Faculty of Medical Sciences
First posted: 2021-11-26
Enrollment: 211
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Sperm parameters
timeFrame: 6 months
measure: Sperm parameters
timeFrame: 6 months
measure: Sperm parameters
timeFrame: 6 months
Secondary outcomes:
measure: oxidative stress parameters
timeFrame: 6 months
measure: oxidative stress parameters
timeFrame: 6 months
measure: oxidative stress parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Tetovo
country: North Macedonia
facility: Univeristy of Tetova
Study officials:
affiliation: University of Tetova
name: Vegim Zhaku, MD, PhDc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tetova
name: Sheqibe Beadini, PhD
role: STUDY_CHAIR
affiliation: Univeristy of Tetova
name: Nexhbedin Beadini, PhD
role: STUDY_CHAIR
References:
citation: 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
citation: ] 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.
citation: 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.
citation: 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.
citation: 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