Loading search results
Sperm DNA Fragmentation (SDF) and Infertility in Males - Impact on ART Outcomes and the Efficacy of Lifestyle Interventions
Sponsor study identifier
interventional
800
0 countries
N/A
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 13, 2026
Actual (reported)August 21, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
From enrollment in RCT to til end of intervention at 12 weeks
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
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.
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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Humaidan P, Haahr T, Povlsen BB, Kofod L, Laursen RJ, Alsbjerg B, Elbaek HO, Esteves SC. The combined effect of lifestyle intervention and antioxidant therapy on sperm DNA fragmentation and seminal oxidative stress in IVF patients: a pilot study. Int Braz J Urol. 2022 Jan-Feb;48(1):131-156. doi: 10.1590/S1677-5538.IBJU.2021.0604.
Saleh RA, Agarwal A, Sharma RK, Nelson DR, Thomas AJ Jr. Effect of cigarette smoking on levels of seminal oxidative stress in infertile men: a prospective study. Fertil Steril. 2002 Sep;78(3):491-9. doi: 10.1016/s0015-0282(02)03294-6.
Peter Humaidan, MD, DMSc
Fertilitetsklinikken Skive, Region Midtjylland
First Submitted
August 13, 2026
First Posted
Contact the study team to confirm eligibility.
Cao LL, Chang JJ, Wang SJ, Li YH, Yuan MY, Wang GF, Su PY. The effect of healthy dietary patterns on male semen quality: a systematic review and meta-analysis. Asian J Androl. 2022 Sep-Oct;24(5):549-557. doi: 10.4103/aja202252.
Li H, Hao W, Maeda E, Kumazawa Y, Takahashi K, Tanaka T, Yokota I, Terada Y, Nomura K, Okada H, Tamakoshi A. Physical activity, sedentary time and sperm DNA fragmentation index in healthy Japanese men. Reprod Biomed Online. 2025 Oct;51(4):105015. doi: 10.1016/j.rbmo.2025.105015. Epub 2025 Apr 17.
Szabo A, Vancsa S, Hegyi P, Varadi A, Forintos A, Filipov T, Acs J, Acs N, Szarvas T, Nyirady P, Kopa Z. Lifestyle-, environmental-, and additional health factors associated with an increased sperm DNA fragmentation: a systematic review and meta-analysis. Reprod Biol Endocrinol. 2023 Jan 18;21(1):5. doi: 10.1186/s12958-023-01054-0.
Simon L, Emery BR, Carrell DT. Review: Diagnosis and impact of sperm DNA alterations in assisted reproduction. Best Pract Res Clin Obstet Gynaecol. 2017 Oct;44:38-56. doi: 10.1016/j.bpobgyn.2017.07.003. Epub 2017 Aug 2.
Christensen P, Fischer R, Schulze W, Baukloh V, Kienast K, Coull G, Parner ET. Role of intra-individual variation in the detection of thresholds for DFI and for misclassification rates: A retrospective analysis of 14,775 SCSA(R) tests. Andrology. 2025 Oct;13(7):1732-1744. doi: 10.1111/andr.13801. Epub 2024 Nov 15.
Santi D, Spaggiari G, Simoni M. Sperm DNA fragmentation index as a promising predictive tool for male infertility diagnosis and treatment management - meta-analyses. Reprod Biomed Online. 2018 Sep;37(3):315-326. doi: 10.1016/j.rbmo.2018.06.023. Epub 2018 Jul 10.
Spano M, Bonde JP, Hjollund HI, Kolstad HA, Cordelli E, Leter G. Sperm chromatin damage impairs human fertility. The Danish First Pregnancy Planner Study Team. Fertil Steril. 2000 Jan;73(1):43-50. doi: 10.1016/s0015-0282(99)00462-8.
Aitken RJ, De Iuliis GN. On the possible origins of DNA damage in human spermatozoa. Mol Hum Reprod. 2010 Jan;16(1):3-13. doi: 10.1093/molehr/gap059. Epub 2009 Jul 31.
August 21, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: