[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06990841":3,"trial-entities:NCT06990841":105,"trial-summary:NCT06990841":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":61,"locations":63,"central_contacts":79,"overall_officials":85,"references":90,"see_also_links":104},"NCT06990841","2295231-1","Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development","A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development","RECRUITING","2026-12","2025-09","2025-09-17","2025-08-11","Richard Kordus, PhD, HCLD (ABB)","OTHER",false,"The goal of this clinical trial is to learn if the LensHooke CA0 device lowers DNA fragmentation in sperm samples compared to a gradient\u002Fswim-up technique.\n\nThe main questions it aims to answer are:\n\n1. Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient\u002Fswim-up technique?\n2. Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient\u002Fswim-up technique?\n3. Is sibling embryo fertilization and development the same?\n4. Are pregnancy rates different between the 2 groups?\n\n1 semen sample will be split between the 2 treatment techniques. Half of the partner's egg cohort will be injected via intra-cytoplasmic sperm using sperm processed by one technique and the other half of the cohort will be injected by the sperm processed by the other technique. Both methods will look at DNA fragmentation, concentration, motility, and morphology of the sperm. Both methods will be compared in the resulting embryos looking at fertilization, embryo development and pregnancy rates.",null,[19,20,21],"DNA Damage","DNA Strand Breaks","Sperm DNA Fragmentation",[],"INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},50,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","sperm separation device","comparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates",[36],"Gradient\u002Fswim-up vs Lenshooke CA0 device comparison",[38],{"measure":39,"description":40,"timeFrame":41},"Percentage of sperm with DNA fragmentation","The method is based on the Sperm Chromatin Dispersion (SCD) test (Fernández et al., J. Androl 24:59-66, 2003; Fertil Steril 84:833-842, 2005). Intact unfixed spermatozoa (fresh, frozen\u002Funthawed, diluted or neat samples) are immersed in an inert agarose microgel on a pretreated slide. An initial acid treatment denatures DNA in those sperm cells with fragmented DNA. Following this, the lysing solution removes most of the nuclear proteins, and in the absence of massive DNA breakage produces nucleoids with large halos of spreading DNA loops, emerging from a central core. However, the nucleoids from spermatozoa with fragmented DNA either do not show a dispersion halo or the halo is minimal. Slides are stained with Wright's stain. A minimum of 300 sperm per sample will be counted. The percentage of sperm with fragmented DNA will be calculated by dividing the sperm with small and no halos (fragmented sperm) by the total number of sperm counted.","From enrollment until day after sample collection, approximately 1 month",[43],{"measure":44,"description":45,"timeFrame":41},"Concentration of sperm per mL","Assessed using a sperm class analyzer - SCA (CASA system) for sperm count. Semen samples will be loaded into 20 microliter depth fixed volume slides. Slides will be placed on the Microoptics SCA machine. Videos will be captured of fields until at least 200 motile sperm are captured. Concentration will be analyzed by counting the number of sperm within each field, corrected for the depth of the chamber, and multipled by the volume of the sample. Concentrations between fields will not vary by more than 15%.","ALL","18 Years","34 Years",true,{"inclusion":51,"exclusion":55,"raw_text":60},[52,53,54],"Samples with ≥15 M\u002FmL spermatozoa concentration","Female partner between 18 and 34 years old.","Minimum of 4 fertilized eggs in gradient\u002Fswim prep group and 4 fertilized eggs in the Lenshooke prep group for each patient",[56,57,58,59],"Samples with \\\u003C15 M\u002FmL spermatozoa concentration","female partner \\>35 years old","female patient with recurrent pregnancy loss","female patient with diminished ovarian reserve","Inclusion Criteria:\n\n* Samples with ≥15 M\u002FmL spermatozoa concentration\n* Female partner between 18 and 34 years old.\n* Minimum of 4 fertilized eggs in gradient\u002Fswim prep group and 4 fertilized eggs in the Lenshooke prep group for each patient\n\nExclusion Criteria:\n\n* Samples with \\\u003C15 M\u002FmL spermatozoa concentration\n* female partner \\>35 years old\n* female patient with recurrent pregnancy loss\n* female patient with diminished ovarian reserve",[62],"ADULT",[64],{"facility":65,"status":8,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":76},"Prisma Health-Upstate Fertility Center of the Caroliinas","Greenville","South Carolina","29605","United States",[71],{"name":72,"role":73,"phone":74,"email":75},"Richard J Kordus, PhD","CONTACT","864-455-1675","rich.kordus@prismahealth.org",{"lat":77,"lon":78},34.85262,-82.39401,[80,81],{"name":72,"role":73,"phone":74,"email":75},{"name":82,"role":73,"phone":83,"email":84},"Patti Parker","864-455-1510","patti.parker@prismahealth.org",[86],{"name":87,"affiliation":88,"role":89},"Richard Kordus, PhD","Prisma Health-Upstate Fertility Center of the Carolinas","PRINCIPAL_INVESTIGATOR",[91,95,98,101],{"pmid":92,"type":93,"citation":94},"34817086","BACKGROUND","Ho CLT, Vaughan-Constable DR, Ramsay J, Jayasena C, Tharakan T, Yap T, Whiteman I, Graham N, Minhas S, Homa ST. The relationship between genitourinary microorganisms and oxidative stress, sperm DNA fragmentation and semen parameters in infertile men. Andrologia. 2022 Mar;54(2):e14322. doi: 10.1111\u002Fand.14322. Epub 2021 Nov 24.",{"pmid":96,"type":93,"citation":97},"35484935","Amor H, Hammadeh ME, Mohd I, Jankowski PM. Impact of heavy alcohol consumption and cigarette smoking on sperm DNA integrity. Andrologia. 2022 Aug;54(7):e14434. doi: 10.1111\u002Fand.14434. Epub 2022 Apr 28.",{"pmid":99,"type":93,"citation":100},"29082146","Cho CL, Agarwal A, Majzoub A, Esteves SC. Clinical utility of sperm DNA fragmentation testing: concise practice recommendations. Transl Androl Urol. 2017 Sep;6(Suppl 4):S366-S373. doi: 10.21037\u002Ftau.2017.07.28.",{"pmid":102,"type":93,"citation":103},"28718529","Rex AS, Aagaard J, Fedder J. DNA fragmentation in spermatozoa: a historical review. Andrology. 2017 Jul;5(4):622-630. doi: 10.1111\u002Fandr.12381.",[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Infertility",[],{"nct_id":4,"found":49,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This interventional study will involve 50 participants. One semen sample from each participant will be split and treated with both techniques for comparison.","completed","Comparing Sperm Processing Methods for DNA Fragmentation and Embryo Development","This study is comparing two ways to prepare sperm: the LensHooke CA0 device and a standard gradient\u002Fswim-up technique. Researchers want to see if the LensHooke CA0 device can reduce DNA fragmentation (damage to sperm DNA) and improve sperm quality. They will also look at how well embryos develop and if pregnancy rates are different between the two methods. You may be able to join if you are a male between 18 and 34 years old with a sperm concentration of at least 15 million\u002FmL, and your female partner is between 18 and 34 years old. The study aims to enroll 50 participants.","The primary endpoint, percentage of sperm with DNA fragmentation, will be measured from enrollment until approximately one month after sample collection.",102,"You will provide one semen sample, which will then be split and processed using two different techniques. The study will measure DNA fragmentation and observe embryo development.","Not stated in the trial record.",[],"v2"]