[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652913":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":12,"responsibleParty":36,"collaborators":39,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":12,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":12,"maxAge":12,"enrollmentInfo":51,"targetDuration":12,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":66,"whyStopped":12,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":12},{"fullName":5,"class":6},"Regionshospitalet Viborg, Skive","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard care","NO_INTERVENTION","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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Lifestyle-intervention","EXPERIMENTAL","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.",[18],"Behavioral: Lifestyle change",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"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 (\\\u003C 6 units\u002Fweek) and participants should refrain from smoking (including the use",[14],[26],{"name":27,"affiliation":28,"role":29},"Peter Humaidan, MD, DMSc","Fertilitetsklinikken Skive, Region Midtjylland","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"Jeanett Nielsen, MD","CONTACT","+4528768439","jelyni@rm.dk",{"type":29,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Peter Humaidan","MD, DMSc",[40],{"name":41,"class":42},"Sagitta Charity Foundation","UNKNOWN","100652913","nordic-sperm-dna-study-100652913",false,"NCT07779954","Nordic Sperm DNA Study","Sperm DNA Fragmentation (SDF) and Infertility in Males - Impact on ART Outcomes and the Efficacy of Lifestyle Interventions","Inclusion Criteria:\n\n* All men of couples qualifying for either their first og second IVF or ICSI treatment\n\nExclusion Criteria:\n\n* Insufficient sperm concentration: In samples with very low sperm counts, sperm DNA fragmentation (SDF) testing may not be technically feasible.\n* Surgically retrieved sperm: Men whose sperm is obtained through testicular or epididymal aspiration (TESA\u002FPESA) will be excluded, to ensure adequate material for planned fertility procedures","MALE",{"count":52,"type":53},800,"ESTIMATED","INTERVENTIONAL",[56],"NA","Introduction\n\nThe 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.\n\nObjectives and methods\n\nThe main research questions are:\n\n1. How common is elevated SDF among Danish men undergoing fertility treatment?\n2. Is elevated SDF associated with reduced live birth rates and increased early pregnancy loss?\n3. Can a 3-month individualized lifestyle intervention reduce SDF in men with high SDF levels (above 20%)?\n\nThe 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.\n\nAll participants will:\n\n* Provide semen samples for sperm DNA fragmentation testing and routine semen analysis.\n* Provide blood samples to measure hormones and other health markers\n\nOn the basis of SDF results participants will either:\n\n* Have SDF of 20% or lower: Continue with routine fertility treatment and follow up.\n* 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.\n\nEthics and dissemination\n\nThe 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.",[59,60,61],"Male Infertility","Sperm DNA Fragmentation","Lifestyle Intervention",[63,64,65],"Male infertility","Sperm DNA fragmentation","Lifestyle intervention","NOT_YET_RECRUITING","2026-08-18",{"date":69,"type":70},"2026-08-21","ACTUAL",{"date":72,"type":53},"2026-09-01",{"date":74,"type":53},"2029-09-01",{"name":5,"class":6}]