Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients (NCT05135143) | Clinical Trial Compass
CompletedPhase 4
Role of Antioxidants in the Reduction of Oxidative Stress in Infertile Patients
North Macedonia211 participantsStarted 2017-09-01
Plain-language 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.
Who can participate
Age range
19 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.