Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-55
SponsorUniversity Medical Center Groningen
About this trial
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
This trial does not accept healthy volunteersQualifiers
Males of couples visiting the CRM at the UMCG between 18-55 years old.
Planned semen-analysis as standard care.
Disqualifiers
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)
Trial population
Males of couples visiting the CRM of the UMCG
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Biomaterial collection for observational purpose
Other interventionThe semen will be collected to measure the free radical concentration in seminal plasma and sperm together with the diversity of microbiota. Both males with a normal semen analysis (SA) and abnormal SA according to the WHO guidelines (2010) will be included. Blood plasma will be collected to measure systemic radical concentration and all outcomes will be related to lifestyle factors and food intake acquired through hospital charts and routinely conducted questionnaires together with a food frequency Questionnaire (FFQ).
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Males of couples seeking fertility treatment1 intervention
Trial outcomes
Primary outcomes
1
Free radical concentration in seminal plasma
Free radical concentration (in mola) in seminal plasma from males of couples visiting the Center of Reproductive Medicine (CRM) of the University Medical Center Groningen (UMCG) is measured using Diamond magnetometry.
Time frame
Within 4 hours after production of semen at baseline2
Determination of seminal microbiome species and their abundance in seminal plasma
The different species and their relative and absolute abundance in seminal microbiota is determined in seminal plasma using qPCR and 16S rRNA sequencing methods (%).
Time frame
Baseline3
Free radical concentration in serum using Diamond magnetometry
Free radical concentration (in mola) in blood serum from males of couples visiting the Center of Reproductive Medicine (CRM) of the University Medical Center Groningen (UMCG) is measured using Diamond magnetometry.
Time frame
Within 2 hours of withdrawal at baseline4
Free thiol levels in serum using the Ellman technique
Free thiol levels in blood serum (in umol/L) from males of couples visiting the Center of Reproductive Medicine (CRM) of the University Medical Center Groningen (UMCG) is measured using the Ellman technique.
Time frame
BaselineSecondary outcomes
1
Relation between concentration of free radicals in semen and the microbiota species composition in seminal plasma
To relate the concentration of free radical in seminal plasma measured in uM with Diamond magnetometry, with the incidence of microbiota (e.g. which species and their abundance) in seminal plasma measured with qPCR and 16S rRNA sequencing methods, to detect a role of microbiota in the concentration of free radicals. Statistical analysis established using SPSS (IBM Corp, Armonk, NY USA).
Time frame
Through study completion, an average of 1 year2
Relation between free radical concentration in seminal plasma and free radical concentration in blood serum.
To relate the concentration of free radicals in seminal plasma measured with Diamond magnetometry with the concentration of free radical in blood serum measured with Diamond magnetometry (uM), to compare systemic and local oxidative stress. Statistical analysis established using SPSS (IBM Corp, Armonk, NY USA).
Time frame
Through study completion, an average of 1 year3
Relation between free radical concentration in seminal plasma and free thiol levels in blood serum.
To relate the concentration of free radicals in seminal plasma measured with Diamond magnetometry with the concentration of free thiols in blood serum (uM) measured with the Ellman technique (1959), to compare systemic and local oxidative stress. Statistical analysis established using SPSS (IBM Corp, Armonk, NY USA).
Time frame
Through study completion, an average of 1 year4
Relation between free radical concentration in seminal plasma and concentration of Malondialdehyde in blood serum.
To relate the concentration of free radicals in seminal plasma measured with Diamond magnetometry with the concentration of Malondialdehyde (uM) using the thiobarbituric acid reactive substance assay (TBARS; Janero 1990), to compare systemic and local oxidative stress. Statistical analysis established using SPSS (IBM Corp, Armonk, NY USA).
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov