[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sperm-dna-fragmentation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sperm-dna-fragmentation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,85,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100640610","clinical-thresholds-of-double-strand-breaks-in-sperms-dna-in-art-100640610",false,"NCT07621991","Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART","A Prospective Trial Assessing the Impact of Double-strand Breaks on ART Outcomes and Predicting Its Clinical Thresholds","DSBs","Inclusion Criteria:\n\n* Males aged 21-55 years undergoing ICSI treatment for male factor infertility.\n* Women with age 21-35 for self-oocyte pickup cycles\n* Oocyte donor cycles with recipient age of 21-35 years of age\n* Sperm with a minimum total motile sperm count of 2.0 million\u002FmL and a minimum volume of 1.2 mL\n* Patients not underwent sperm DNA fragmentation testing\n* 2-3 days of abstinence prior to intracytoplasmic sperm injection (ICSI).\n\nExclusion Criteria:\n\n* Severe male factor infertility (azoospermia or severe oligozoospermia; for this study defined as no sperm present or sample with \\\u003C2 million\u002Fml sperm count)\n* Known systemic diseases (e.g., diabetes mellitus).\n* Surgically retrieved sperms using testicular sperm aspiration, testicular sperm extraction and percutaneous epididymal sperm aspiration.\n* Untreated endometrial or uterine factors or adnexal pathology\n* Embryos underwent preimplantation genetic testing for aneuploidy testing.\n* Patients with thin endometrium (\\\u003C7mm)\n* Patients opted or underwent donor sperms as the male gamete source.\n* Patients underwent antioxidant treatment in last 6 months prior to ICSI treatment.",true,"ALL","21 Years","55 Years",{"count":22,"type":23},484,"ESTIMATED","OBSERVATIONAL","The goal of this prospective observational study is to learn about the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic sperm injection (ICSI). The main questions it aims to answer are:\n\n* Can clinically relevant threshold values of dsSDF and global SDF predict live birth rates following ICSI?\n* Does elevated dsSDF reduce live birth rates following ICSI? Participants undergoing ICSI as part of their routine fertility treatment will provide semen samples for global SDF and dsSDF assessment using the R10 Plus and R11 Plus kits, respectively, analysed using the LensHooke® X12 platform before and after sperm preparation. SDF and dsSDF assessments will be performed both prior to and following sperm washing for each participant. Embryos will be assessed from fertilization through embryo development, and following embryo transfer, participants will be prospectively followed for clinical outcomes ranging from biochemical pregnancy to live birth.",[27,28],"Sperm DNA Fragmentation","Sperm DNA Impact on ART Outcomes",[30,31,32,33,34],"Sperm DNA fragmentation","Double-strand sperm DNA fragmentation","LensHooke® X12","ntracytoplasmic sperm injection","Live birth","NOT_YET_RECRUITING","2026-06-03",{"date":38,"type":39},"2026-06-05","ACTUAL",{"date":41,"type":23},"2026-06-01",{"date":43,"type":23},"2027-12-01",{"name":45,"class":46},"Indira IVF Hospital Pvt Ltd","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100564483","the-epic-study-exploring-paternal-age-and-the-influence-on-blastocyst-culture-100564483","NCT06629766","The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture","EPIC","Inclusion Criteria:\n\n* Undergoing first IVF cycle\n* Electing single embryo transfer\n* Electing PGT-A of their embryos\n* Female partners age \\\u003C42 years old at start of VOR cycle, but \\>18 years old.\n* AMH ≥ 1.2 ng\u002FmL\n* AFC ≥ 8\n* FSH ≤ 12IU\u002FL\n* At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize\n* Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure\n\nExclusion Criteria:\n\n* Contraindication to IVF\n* Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)\n* Male partner with azoospermia or oligozoospermia (\\\u003C500,000 total motile spermatozoa on the most recent semen analysis within one year of enrollment)\n* Planned for previously cryopreserved sperm to be used for ICSI\n* Donor sperm\n* Male partner with Y-chromosome microdeletion\n* Male partner with any Karyotype other than 46,XY\n* Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures\n* Uncorrected hydrosalpinges that communicate with the endometrial cavity\n* Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \\\u003C6mm,), or persistent endometrial fluid\n* Donor oocyte or embryo cycles\n* Gestational carriers","FEMALE","18 Years","41 Years",{"count":59,"type":23},100,"INTERVENTIONAL",[62],"NA","This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.",[65,66,27,67,68],"Infertility (IVF Patients)","Oocyte Competence","Paternal Age","Sperm Selection",[70,71,72,73,74,75],"microfluidic","density grade centrifugation","sperm selection","paternal age","sperm DNA fragmentation","Zymot","RECRUITING",{"date":36,"type":39},{"date":79,"type":39},"2025-04-09",{"date":81,"type":23},"2028-12",{"name":83,"class":46},"Reproductive Medicine Associates of New Jersey",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":92,"minAge":56,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":60,"phases":96,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100618872","royal-jelly-supplementation-in-unexplained-male-infertility-100618872","NCT07337265","Royal Jelly Supplementation in Unexplained Male Infertility","Effect of Oral Royal Jelly Supplementation on Sperm DNA Fragmentation Index and Pregnancy in Couples With Unexplained Infertility: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study","Inclusion Criteria:\n\n* Men aged 18-45 years. History of infertility for at least 1 year despite unprotected intercourse.\n\nDiagnosis of unexplained infertility with Normozoospermia according to WHO 2021 (6th Ed.) criteria:\n\nConcentration ≥ 16 million\u002FmL Total Motility ≥ 42% Progressive Motility ≥ 30% Normal Morphology (Kruger) ≥ 4% Female partner with normal gynecological evaluation (regular ovulation, normal ovarian reserve, and proven tubal patency via HSG).\n\nNormal serum hormone levels (Testosterone, FSH, LH)\n\nExclusion Criteria:\n\n* Any abnormality in spermiogram (Oligo-, Asteno-, or Teratozoospermia). Presence of clinical varicocele. Leukocytospermia (\\>1 million\u002FmL) or active infection. History of smoking (\\>5 cigarettes\u002Fday) or BMI \\> 30 kg\u002Fm². Use of any antioxidant supplementation within the last 3 months.","MALE","45 Years",{"count":95,"type":23},80,[62],"This randomized, double-blind, placebo-controlled clinical trial investigates the effects of oral Royal Jelly supplementation on sperm DNA fragmentation and pregnancy rates in couples with unexplained infertility. While routine semen analysis appears normal (normozoospermia) in these patients, underlying Sperm DNA Fragmentation (SDF) and oxidative stress are believed to contribute to reproductive failure.\n\nParticipants will be randomized to receive either 750 mg of lyophilized Royal Jelly or a placebo daily for a period of 3 months (90 days). The study aims to evaluate whether the antioxidant properties of Royal Jelly can improve sperm chromatin integrity, reduce oxidative stress markers, and increase spontaneous pregnancy rates compared to the control group",[99,100,27],"Unexplained Infertility","Male Infertility",[102,103,104],"royal jelly","unexplained male infertility","sperm dna fragmentation","2026-01-01",{"date":107,"type":39},"2026-01-13",{"date":109,"type":23},"2026-02-01",{"date":111,"type":23},"2026-08-01",{"name":113,"class":46},"Medipol University",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":60,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":84},"100592239","comparison-of-two-different-sperm-processing-methods-and-their-effects-on-sperm-dna-fragmentation-and-embryo-development-100592239","NCT06990841","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","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","34 Years",{"count":123,"type":23},50,[62],"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.",[127,128,27],"DNA Damage","DNA Strand Breaks","2025-09-10",{"date":131,"type":39},"2025-09-17",{"date":133,"type":39},"2025-08-11",{"date":135,"type":23},"2026-12",{"name":137,"class":46},"Richard Kordus, PhD, HCLD (ABB)"]