NCT05514223 Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors
| NCT ID | NCT05514223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Infertility, Male |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The cause of infertility can be due to a female factor or a male factor. In case of a male factor, it is often due to poor semen quality. However, the cause of poor quality is often unknown. In previous research, infertility problems in men were related to chemical processes in metabolism causing the formation of free radicals. Free radicals are physiological by-products of our body mechanisms. Free radicals are very reactive and can therefore react with a lot of molecules of cells within our body and cause damage. A balance between free radicals, which are also needed for physiological processes in the body, and antioxidants, which defuses the reactive free radicals, is most desirable. However, as stated in literature, there are a lot of factors that can influence extra free radical production, which causes overloading of the system, resulting in damage on cellular level. Free radicals in semen plasma and on the sperm cell could play a role in male infertility. Nonetheless, free radicals are not used as diagnostic markers due to the lack of detection systems, as free radicals are very short-lived. This study aims to introduce a new technique, called diamond magnetometry, to measure free radicals directly on the sperm cell and in serum. Diamond magnetometry involves very small diamond particles as magnetic sensors that engage a reaction with the free radicals on the sperm cell, causing signals that can be measured. To compare local free radical production with systemic free radical production, other diagnostic biomarkers are also measured in serum. It is hypothesized that the composition of seminal microbiome could influence the free radical concentration. Therefore, this study also aims to explore the microbiota composition and see if this has an influence in semen quality and free radical production. At last, this study also want to correlate standard semen parameters (defined by the World Health Organisation), lifestyle factors and food intake, to detect a role for lifestyle in the production of free radicals.
Eligibility Criteria
Inclusion Criteria: * Males of couples visiting the CRM at the UMCG between 18-55 years old. * Planned semen-analysis as standard care. Exclusion Criteria: * Males who receive(d) chemo- and/or radiotherapy, use(d) testosterone suppletion and/or anabolic steroids * Males who are azoospermic * Males who have an abnormal SA due to genetic causes. * Semen analysis with round cells \>2x106 /ml (as marker for infection) * Males who currently use antibiotics
Contact & Investigator
Astrid EP Cantineau
PRINCIPAL INVESTIGATOR
University Medical Centre Groningen; Centre of Reproductive Medicine
Frequently Asked Questions
Who can join the NCT05514223 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 55 Years, studying Infertility, Male. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05514223 currently recruiting?
Yes, NCT05514223 is actively recruiting participants. Contact the research team at a.e.p.cantineau@umcg.nl for enrollment information.
Where is the NCT05514223 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT05514223 clinical trial?
NCT05514223 is sponsored by University Medical Center Groningen. The principal investigator is Astrid EP Cantineau at University Medical Centre Groningen; Centre of Reproductive Medicine. The trial plans to enroll 80 participants.