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

Primary Purpose

Infertility, Oligoasthenozoospermia, Male

Status
Completed
Phase
Phase 4
Locations
North Macedonia
Study Type
Interventional
Intervention
Antioxidant formula
Sponsored by
University of Tetova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infertility focused on measuring antioxidant, oxidative stress, sperm parameters, Malonedialdehyde, total antioxidant capacity

Eligibility Criteria

19 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Univeristy of Tetova

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Infertility male patients

Control group

Arm Description

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.

Placebo treatment and control and comparative variables will be measured.

Outcomes

Primary Outcome Measures

Sperm parameters
Concentration (10x6 ml)
Sperm parameters
Morphology (percentage)
Sperm parameters
Motility (percentage)

Secondary Outcome Measures

oxidative stress parameters
MDA (mg/ml)
oxidative stress parameters
Caspase 3 (IU/ml)
oxidative stress parameters
TAC (IU/ml)

Full Information

First Posted
October 25, 2021
Last Updated
November 27, 2021
Sponsor
University of Tetova
Collaborators
University of Tetova, Faculty of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05135143
Brief Title
Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
Acronym
OAT
Official Title
Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tetova
Collaborators
University of Tetova, Faculty of Medical Sciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: Identifying new cases and taking measures early, in order to overcome fertilization problems; For the first time in North Macedonia there will be a more accurate picture of the prevalence of male infertility; Expanding current scientific knowledge about the role of oxidative stress, its laboratory evaluation, and the impact of antioxidant supplements; 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; 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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Oligoasthenozoospermia, Male
Keywords
antioxidant, oxidative stress, sperm parameters, Malonedialdehyde, total antioxidant capacity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infertility male patients
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo treatment and control and comparative variables will be measured.
Intervention Type
Combination Product
Intervention Name(s)
Antioxidant formula
Intervention Description
Administration of antioxidant formula 3 times a day and once daily.
Primary Outcome Measure Information:
Title
Sperm parameters
Description
Concentration (10x6 ml)
Time Frame
6 months
Title
Sperm parameters
Description
Morphology (percentage)
Time Frame
6 months
Title
Sperm parameters
Description
Motility (percentage)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
oxidative stress parameters
Description
MDA (mg/ml)
Time Frame
6 months
Title
oxidative stress parameters
Description
Caspase 3 (IU/ml)
Time Frame
6 months
Title
oxidative stress parameters
Description
TAC (IU/ml)
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Because investigators have to measure sperm parameters
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegim Zhaku, MD, PhDc
Organizational Affiliation
University of Tetova
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheqibe Beadini, PhD
Organizational Affiliation
University of Tetova
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nexhbedin Beadini, PhD
Organizational Affiliation
Univeristy of Tetova
Official's Role
Study Chair
Facility Information:
Facility Name
Univeristy of Tetova
City
Tetovo
ZIP/Postal Code
6338
Country
North Macedonia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Sperm parameters before and after treatment. OS parameters before and after treatment.
Citations:
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
Results Reference
background
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.
Results Reference
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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.
Results Reference
background
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.
Results Reference
background
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
Results Reference
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Links:
URL
https://www.intechopen.com/chapters/77097
Description
Male infertility, Oxidative Stress and Antioxidants
URL
https://eprints.unite.edu.mk/561/
Description
ROLE OF ANTIOXIDANTS IN THE DIMINUTION OF OXIDATIVE STRESS AND AMELIORATION OF SEMEN PARAMETERS IN IDIOPATHIC MALE INFERTILITY
URL
https://keypublishing.org/jhed/jhed-volumes/jhed-volume-26-fqs-3-vegim-zhaku-sheqibe-beadini-nexhbedin-beadini-besir-murtezan-2019-combination-of-maca-korean-ginseng-extract-and-antioxidant-therapy-for-male-with-oligoasthenozoos/
Description
COMBINATION OF MACA, KOREAN GINSENG EXTRACT AND ANTIOXIDANT THERAPY FOR MALE WITH OLIGOASTHENOZOOSPERMIA: CASE STUDY
URL
https://www.endocrine-abstracts.org/ea/0070/ea0070ep581
Description
Oral antioxidants improve sperm motility, sperm concentration and reduce oxidative stress in males with oligoasthenozoospermia

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Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients

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