Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility: An Observational Study on Factors Influencing the Treatment Effects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 主要终点
- DFI
研究概览
简要总结
The investigators will investigate the effect of antioxidants and lifestyle factors on the level of oxidative stress. As oxidative stress cannot be directly measured, it will be approximated by the DNA fragmentation index (DFI) which reflects the level of DNA damage in sperm caused by oxidative stress.
详细描述
This is a one-site prospective exploratory study at the University Clinic for Gynaecological Endocrinology and Reproductive Medicine in Bern. On total 78 men with male infertility will be recruited.
The primary objective of the study is to assess the effectiveness of 3 months of antioxidant-based therapy on changing patients' DFI level.
The objective of the study is to assess the effect of 3 months of antioxidant-based therapy on the level of DFI. We are primarily interested in testing whether the treatment effectiveness (i.e. the change in DFI level) depends on the initial level (i.e. before treatment) and treatment adherence.
The data will be collected by the physicians and added to the REDcap study registry. Access to the total data set is only permitted for the principal investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Willing to participate
- •Written consent
- •Men with infertility problems who want to start an infertility treatment with their partner
排除标准
- •No measurement of DNA fragmentation possible
- •Intake of prescribed medications
- •Exposure to toxins
- •Chronic diseases
结局指标
主要结局
DFI
时间窗: At baseline and after three months of antioxidant-treatment
DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)
次要结局
- Sperm concentration(At baseline and after three months of antioxidant-treatment)
- Implantation rate(10-12 days after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment)
- Clinical pregnancy rate(5 weeks after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment)
- Oxidation-reduction potential in ejaculate(At baseline and after three months of antioxidant-treatment)
- Live birth rate(9 months after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment)
- Alcohol consumption(At baseline and during the three months of antioxidant-treatment)
- BMI(At baseline and after the three months of antioxidant-treatment)
- Sperm motility(At baseline and after three months of antioxidant-treatment)
- Treatment adherence(During three months of antioxidants)
- Smoking(At baseline and during the three months of antioxidant-treatment)
研究者
Janna Pape
Principal Investigator, Dr. med. Janna Pape
Universitätsklinik fur Frauenheilkunde, Inselspital Bern