Sperm DNA Fragmentation (SDF) and Infertility in Males - Impact on ART Outcomes and the Efficacy of Lifestyle Interventions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 主要终点
- SDF change
研究概览
简要总结
Introduction
The goal of this prospective observational study with an embedded randomized controlled trial (RCT) is to investigate the prevalence and clinical significance of sperm DNA fragmentation (damage to the genetic material in sperm cells) (SDF) among men undergoing fertility treatment and to determine whether an individualized lifestyle programme can reduce SDF and improve pregnancy outcomes. The study includes approximately 800 men undergoing fertility treatment at a Danish fertility clinic.
Objectives and methods
The main research questions are:
- How common is elevated SDF among Danish men undergoing fertility treatment?
- Is elevated SDF associated with reduced live birth rates and increased early pregnancy loss?
- Can a 3-month individualized lifestyle intervention reduce SDF in men with high SDF levels (above 20%)?
The whole cohort will participate in the observational study. Participants with SDF above 20% will be invited to take part in the randomized controlled trial. In the RCT researchers will compare men randomized to an individualized lifestyle intervention with men receiving standard fertility care to determine whether the intervention reduces sperm DNA fragmentation and improves subsequent pregnancy outcomes.
All participants will:
- Provide semen samples for sperm DNA fragmentation testing and routine semen analysis.
- Provide blood samples to measure hormones and other health markers
On the basis of SDF results participants will either:
- Have SDF of 20% or lower: Continue with routine fertility treatment and follow up.
- Have SDF above 20%: Be randomly assigned to either a personalised 3-month lifestyle programme or standard fertility care. Participants in the lifestyle programme will receive personalised advice on diet, physical activity, smoking, alcohol, sleep, stress management and antioxidant supplements.
Ethics and dissemination
The study has been approved by the Regional Committee on health research ethics and complies with the General Data Protection Regulation. Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed scientific journals, conference presentations, trial registry reporting, and communication with participants and relevant stakeholders.
详细描述
Introduction
Male factor infertility contributes substantially to infertility, but conventional semen analysis does not fully assess sperm function. Sperm DNA fragmentation (SDF), damage to the genetic material in sperm cells, has been proposed as a marker of male reproductive potential. However, SDF testing is not currently part of routine fertility assessment in Denmark, and the prevalence and clinical relevance of elevated SDF among Danish men undergoing fertility treatment are not well established.
Oxidative stress and lifestyle-related factors may contribute to sperm DNA damage. Lifestyle modification may therefore be a potential approach to lowering SDF. However, evidence from randomized controlled trials evaluating the effect of a comprehensive lifestyle intervention on SDF is limited.
The overall aim of this prospective research programme is to investigate the prevalence and clinical significance of SDF among men undergoing fertility treatment and to evaluate whether a 3-month individualized lifestyle intervention can reduce SDF and improve subsequent reproductive outcomes.
Study design and study components
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the lifestyle intervention participants cannot be blinded. However, outcome assessors (both medical laboratory scientists assessing the post-intervention SDF levels and study physicians assessing treatment outcomes) will remain blinded to treatment allocation. Samples and study data will be pseudonymised using unique study identification numbers before assessment to maintain blinding.
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All men of couples qualifying for either their first og second IVF or ICSI treatment
排除标准
- •Insufficient sperm concentration: In samples with very low sperm counts, sperm DNA fragmentation (SDF) testing may not be technically feasible.
- •Surgically retrieved sperm: Men whose sperm is obtained through testicular or epididymal aspiration (TESA/PESA) will be excluded, to ensure adequate material for planned fertility procedures
研究组 & 干预措施
Standard care
Participants randomized to the control group will receive standard fertility care according to routine clinical practice at the clinic. They will not receive additional lifestyle counselling.
Lifestyle-intervention
Participants randomized to the intervention group will take part in a personalised 3-month lifestyle programme. The programme will be tailored to each participant based on their lifestyle and health information provided in questionnaire prior ro randomization. Participants will receive personalised advice about diet, exercise, smoking, alcohol habits, caffeine intake, stress level and the use of dietary supplements. Participants will also use a lifestyle app to record their diet, physical activity, sleep and stress. Halfway through the programme a follow-up will be planned with each participant.
干预措施: Lifestyle change (Behavioral)
结局指标
主要结局
SDF change
时间窗: From enrollment in RCT to til end of intervention at 12 weeks
Change in Sperm DNA Fragmentation (SDF), expressed as a percentage from 0% to 100%, from baseline to 3 months after initiation of the intervention. Lower scores indicate less sperm DNA fragmentation and therefore a better outcome
次要结局
- Live birth rate(From initiation of the first ART cycle after the intervention until live birth (approximately 9-12 months))
- Change in semen volume(From enrollment to the end of intervention at 12 weeks)
- Change in sperm concentration(From enrollment to the end of intervention at 12 weeks)
- Change in total sperm count(From enrollment to the end of intervention at 12 weeks)
- Change in total sperm motility(From enrollment to the end of intervention at 12 weeks)
- Change in normal sperm morphology(From enrollment to the end of intervention at 12 weeks)
- Early pregnancy loss(From confirmation of clinical pregnancy following the first ART cycle after the intervention until 12 weeks of gestation.)
研究者
Peter Humaidan
MD, DMSc
Regionshospitalet Viborg, Skive