Investigation of effects of antioxidants on human spermatozoa from patients with various reproductive pathologies

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035009

Enrollment

Registered

2024-09-16

Start date

2023-11-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I86 N46 R86

Interventions

Group 1: Non-interventional study: Semen samples pretreated with chlorogenic acid (100µM chlorogenic acid for 1 hour) are analyzed from 59 patients. Control groups are untreated semen samples from the

Eligibility

Sex/Gender

Male

Age

25 Years to 50 Years

Inclusion criteria

Inclusion criteria: restricted spermiogram, variocele or leucocytospermia

Exclusion criteria

Exclusion criteria: normozoospermia

Design outcomes

Primary

Measure	Time frame
The aim of the study is to determine whether there is an effect of treating human spermatozoa with chlorogenic acid as an antioxidant. It is being investigated whether a positive effect, i.e. a benefit, can be measured for the fertility of patients through the effect of chlorogenic acid. The endpoint for analysis is reached when a statistically meaningful number of patient samples has been analyzed. The test will be carried out for the first time when the number of 59 samples examined, including their controls, has been reached. Further samples from patients will be included in the study until a statistically relevant statement can be made. The comparison between the considered semen variables of samples treated with chlorogenic acid and control will elucidate the possible statistical differences and a possible protective/antioxidant effect of chlorogenic acid. Statistical analysis will be performed with the SPSS version 17.0 for Windows software package (SPSS Inc, Chicago, IL, USA). First, we will test the normality of the variables by Kolmogorov-Smirnov test. Generally, in this kind of research the distribution, also due to the limited number of cases, is not normal and appropriated non parametric tests will be applied. 1)For an eventual normal distribution, we will use t-student test to compare two different groups (example group 1 treated and group 2 control) and the data will be reported as mean and standard deviation (sd). 2)For an eventual non normal distribution we will apply non parametric tests as Mann-Whitney test. In this case the data will be expressed as median and 25th -75th centiles; P<0.05 will be considered significant.	—

Measure

Time frame

The aim of the study is to determine whether there is an effect of treating human spermatozoa with chlorogenic acid as an antioxidant. It is being investigated whether a positive effect, i.e. a benefit, can be measured for the fertility of patients through the effect of chlorogenic acid. The endpoint for analysis is reached when a statistically meaningful number of patient samples has been analyzed. The test will be carried out for the first time when the number of 59 samples examined, including their controls, has been reached. Further samples from patients will be included in the study until a statistically relevant statement can be made. The comparison between the considered semen variables of samples treated with chlorogenic acid and control will elucidate the possible statistical differences and a possible protective/antioxidant effect of chlorogenic acid. Statistical analysis will be performed with the SPSS version 17.0 for Windows software package (SPSS Inc, Chicago, IL, USA). First, we will test the normality of the variables by Kolmogorov-Smirnov test. Generally, in this kind of research the distribution, also due to the limited number of cases, is not normal and appropriated non parametric tests will be applied. 1)For an eventual normal distribution, we will use t-student test to compare two different groups (example group 1 treated and group 2 control) and the data will be reported as mean and standard deviation (sd). 2)For an eventual non normal distribution we will apply non parametric tests as Mann-Whitney test. In this case the data will be expressed as median and 25th -75th centiles; P<0.05 will be considered significant.

—

Countries

Germany

Contacts

Public ContactKarl Sterzik

MVZ Next Fertility Ulm GmbH

karl.sterzik@next-fertility.de+49731151590

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026