Nordic Sperm DNA Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorRegionshospitalet Viborg, Skive
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All men of couples qualifying for either their first og second IVF or ICSI treatment
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle change
BehavioralIn 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
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Standard careNo intervention 0 interventions
Group B: Lifestyle-interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SDF change
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
Time frame
From enrollment in RCT to til end of intervention at 12 weeksSecondary outcomes
1
Live birth rate
Live birth rate, defined as the proportion of participants achieving a live birth following the first ART cycle after the intervention.
Time frame
From initiation of the first ART cycle after the intervention until live birth (approximately 9-12 months)2
Change in semen volume
Semen volume will be measured in milliliters (mL) according to the World Health Organization (WHO) Laboratory Manual for the Examination and Processing of Human Semen, 6th edition.
Time frame
From enrollment to the end of intervention at 12 weeks3
Change in sperm concentration
Sperm concentration will be measured as the number of spermatozoa per milliliter of semen according to the World Health Organization (WHO) Laboratory Manual for the Examination and Processing of Human Semen, 6th edition.
Time frame
From enrollment to the end of intervention at 12 weeks4
Change in total sperm count
Total sperm count will be calculated as the total number of spermatozoa in the ejaculate according to the World Health Organization (WHO) Laboratory Manual for the Examination and Processing of Human Semen, 6th edition.
Time frame
From enrollment to the end of intervention at 12 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Regionshospitalet Viborg, Skive
Lead sponsor
Sagitta Charity Foundation
Collaborator
Source ClinicalTrials.gov
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