InfertilityPhase 4OATNCT05135143
Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
A Phase 4 study testing Antioxidant formula in people with Infertility and Oligoasthenozoospermia, run by University of Tetova at 1 site in North Macedonia.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 45 years, men only
- Conditions the study is for
- Infertility, Oligoasthenozoospermia, Male
- What is being tested?
- Antioxidant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 1 Sep 2017to 31 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infertility, Oligoasthenozoospermia, Male
- Being tested
- Antioxidant formula
- Keywords
- antioxidant, oxidative stress, sperm parameters, Malonedialdehyde, total antioxidant capacity
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant formulaCombination product
Administration of antioxidant formula 3 times a day and once daily.
| Study group | Role | What they receive |
|---|---|---|
| Infertility male patients | Active comparator | 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. Receives: Combination Product: Antioxidant formula |
| Control group | Placebo comparator | Placebo treatment and control and comparative variables will be measured. Receives: Combination Product: Antioxidant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm parameters
Concentration (10x6 ml)
Measured: 6 months
Sperm parameters
Morphology (percentage)
Measured: 6 months
Sperm parameters
Motility (percentage)
Measured: 6 months
Secondary outcomes (3)
oxidative stress parameters
MDA (mg/ml)
Measured: 6 months
oxidative stress parameters
Caspase 3 (IU/ml)
Measured: 6 months
oxidative stress parameters
TAC (IU/ml)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Sep 2017
- Primary completion30 Jun 2019
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tetova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tetova, Faculty of Medical Sciences
- Responsible party
- Principal investigator, Vegim Zhaku, University of Tetova
- Investigators
- Vegim Zhaku, MD, PhDc, Principal investigator, University of TetovaSheqibe Beadini, PhD, Study chair, University of TetovaNexhbedin Beadini, PhD, Study chair, Univeristy of Tetova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135143
- Sponsor's protocol ID
- 22-63/3
- Acronym
- OAT
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sperm parameters before and after treatment. OS parameters before and after treatment.
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
- ClinicalTrials.gov ID
- NCT05135143
- Acronym / sponsor ID
- OAT / 22-63/3
- Conditions
- Infertility, Oligoasthenozoospermia, Male
- Keywords
- antioxidant, oxidative stress, sperm parameters, Malonedialdehyde, total antioxidant capacity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of TetovaUniversity, hospital or other
- Collaborators
- University of Tetova, Faculty of Medical Sciences
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind randomized
| Arm | Type | Receives |
|---|---|---|
| Infertility male patients | Active comparator | Combination Product: Antioxidant formulaInfertile 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. |
| Control group | Placebo comparator | Combination Product: Antioxidant formulaPlacebo treatment and control and comparative variables will be measured. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidant formulaAdministration of antioxidant formula 3 times a day and once daily. | Combination product | Control group, Infertility male patients |
Primary outcome
Sperm parameters
Time frame: 6 months
Concentration (10x6 ml)
Sperm parameters
Time frame: 6 months
Morphology (percentage)
Sperm parameters
Time frame: 6 months
Motility (percentage)
3 secondary outcomes
oxidative stress parameters
Time frame: 6 months
oxidative stress parameters
Time frame: 6 months
oxidative stress parameters
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- BackgroundVegim 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
- Background] 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.
- BackgroundZhaku 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.
- BackgroundZhaku 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.
- BackgroundZhaku 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
- Male infertility, Oxidative Stress and AntioxidantsLink provided by the sponsor.
- ROLE OF ANTIOXIDANTS IN THE DIMINUTION OF OXIDATIVE STRESS AND AMELIORATION OF SEMEN PARAMETERS IN IDIOPATHIC MALE INFERTILITYLink provided by the sponsor.
- COMBINATION OF MACA, KOREAN GINSENG EXTRACT AND ANTIOXIDANT THERAPY FOR MALE WITH OLIGOASTHENOZOOSPERMIA: CASE STUDYLink provided by the sponsor.
- Oral antioxidants improve sperm motility, sperm concentration and reduce oxidative stress in males with oligoasthenozoospermiaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Sperm parameters before and after treatment. OS parameters before and after treatment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegim Zhaku, MD, PhDc principal investigator
University of Tetova
Sheqibe Beadini, PhD study chair
University of Tetova
Nexhbedin Beadini, PhD study chair
Univeristy of Tetova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antioxidant formula in people with Infertility and Oligoasthenozoospermia, run by University of Tetova at 1 site in North Macedonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm parameters (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05135143, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.