Nordic Sperm DNA Study

Summary

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:

1. How common is elevated SDF among Danish men undergoing fertility treatment?
2. Is elevated SDF associated with reduced live birth rates and increased early pregnancy loss?
3. 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.

Conditions

• Male Infertility
• Sperm DNA Fragmentation
• Lifestyle Intervention

Interventions

BEHAVIORAL

Lifestyle change

In terms of diet, participants will be advised to reduce caloric intake, salt and saturated fat while increasing the consumption of fruit and vegetables. Additionally, they will be encouraged to limit intake of ultra processed food as well as sugary and- caffeinated beverages. Recommendations on physical activity will be offered on an individual basis to promote a balanced approach and to ensure motivation of the individual. Participants not regularly engaging in physical activity will be advised to perform a daily minimum of 30 minutes of moderate activity i.e. fast-pace walking, jogging or cycling. Those who already exercise regularly and with high intensity will be counselled as to avoid over-exercising as this has proven a negative impact on sperm quality. Alcohol consumption should be kept to a minimum (\< 6 units/week) and participants should refrain from smoking (including the use

Sponsors & Collaborators

• Sagitta Charity Foundation

  collaborator UNKNOWN

• Regionshospitalet Viborg, Skive

  lead OTHER

Principal Investigators

• Peter Humaidan, MD, DMSc · Fertilitetsklinikken Skive, Region Midtjylland

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-05-01

Completion

2029-09-01