[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infertility-male\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infertility-male":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,55,82,110,133,156,183,208,231,247,272,303,329],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100478765","measuring-free-radicals-in-human-sperm-cells-related-to-microbiota-and-lifestyle-factors-100478765",false,"NCT05514223","Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors","MeaSuring Free radIcals With Diamond magnetometrRy In hUman Single Sperm Cells Related to Microbiota and Lifestyle Factors","SIRIUS","Inclusion Criteria:\n\n* Males of couples visiting the CRM at the UMCG between 18-55 years old.\n* Planned semen-analysis as standard care.\n\nExclusion Criteria:\n\n* Males who receive(d) chemo- and\u002For radiotherapy, use(d) testosterone suppletion and\u002For anabolic steroids\n* Males who are azoospermic\n* Males who have an abnormal SA due to genetic causes.\n* Semen analysis with round cells \\>2x106 \u002Fml (as marker for infection)\n* Males who currently use antibiotics","MALE","18 Years","55 Years",{"count":21,"type":22},80,"ESTIMATED","OBSERVATIONAL","The cause of infertility can be due to a female factor or a male factor. In case of a male factor, it is often due to poor semen quality. However, the cause of poor quality is often unknown. In previous research, infertility problems in men were related to chemical processes in metabolism causing the formation of free radicals. Free radicals are physiological by-products of our body mechanisms. Free radicals are very reactive and can therefore react with a lot of molecules of cells within our body and cause damage. A balance between free radicals, which are also needed for physiological processes in the body, and antioxidants, which defuses the reactive free radicals, is most desirable. However, as stated in literature, there are a lot of factors that can influence extra free radical production, which causes overloading of the system, resulting in damage on cellular level. Free radicals in semen plasma and on the sperm cell could play a role in male infertility. Nonetheless, free radicals are not used as diagnostic markers due to the lack of detection systems, as free radicals are very short-lived. This study aims to introduce a new technique, called diamond magnetometry, to measure free radicals directly on the sperm cell and in serum. Diamond magnetometry involves very small diamond particles as magnetic sensors that engage a reaction with the free radicals on the sperm cell, causing signals that can be measured. To compare local free radical production with systemic free radical production, other diagnostic biomarkers are also measured in serum.\n\nIt is hypothesized that the composition of seminal microbiome could influence the free radical concentration. Therefore, this study also aims to explore the microbiota composition and see if this has an influence in semen quality and free radical production. At last, this study also want to correlate standard semen parameters (defined by the World Health Organisation), lifestyle factors and food intake, to detect a role for lifestyle in the production of free radicals.",[26,27],"Infertility, Male","Infertility",[29,30,31,32,33,34,35,36,37,38,39,40,41],"Free radicals","Reactive oxygen species","Microbiota","Diet","Dietary patterns","Fertility","Semen analysis","Fertility clinics","Diamond magnetometry","Lifestyle","Semen","Oxidative stress","Food frequency questionnaire","RECRUITING","2026-05-07",{"date":45,"type":46},"2026-05-08","ACTUAL",{"date":48,"type":46},"2024-06-01",{"date":50,"type":22},"2027-09-30",{"name":52,"class":53},"University Medical Center Groningen","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":54},"100636918","phase-1-a-novel-aromatase-inhibitor-leflutrozole-for-treatment-of-non-obstructive-azoospermia-100636918","NCT07571928","A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia","The NOVA-NOA Trial A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia A Prospective Interventional Study","NOVA-NOA","Inclusion Criteria:\n\n* Signed informed consent by participant\n* Signed informed consent by participant's partner (must just be obtained before the par-ticipant starts treatment at Visit 1), if applicable, regarding blood samples, data collec-tion about fertility treatment as well as pregnancy and pregnancy outcome\n* 18-55 years\n* Azoospermia verified by at least 2 semen samples, average semen volume \\>= 1,0 ml with no identifiable sign of obstruction (samples taken at Visit -1 and at Visit 0 prior to confirmation of eligibility and dosing).\n* Serum AMH or Inhibin B level above the lower limit of quantification (LLOQ) at screening or within 6 months prior to screening\n* Testosterone \\\u003C 15 nmol\u002FL at screening or within 6 months prior to screening\n* Serum estradiol above the lower limit of normal range (48 pmol\u002FL) at screening or within 6 months prior to screening\n\nExclusion Criteria:\n\n* Klinefelter or other major genetic conditions including large deletions on sex chromosomes\n* Average testis size \\> 20 mL unless obstruction has been excluded\n* TESE procedure \\\u003C ½ year ago\n* LH concentration \\> 15 IU\u002FL at screening\n* Current abuse of steroids\n* BMI \\> 45 kg\u002Fm2\n* Severe chronic diseases requiring daily medication\n* Prior thromboembolic event within the last 24 months\n* Cardiovascular event within the last 6 months judged as significant by the investigator\n* Osteoporosis requiring medical treatment\n* Use of any prescription or non-prescription medication (apart from routine vitamins, occasional use of paracetamol, acetylsalicylic acid, or ibuprofen) which could interfere with pharmacokinetic or pharmacodynamic results, as judged by the investigator, such as:\n\n  * Herbal products and non-routine vitamins\n  * Insulin\n  * Medication such as systemic corticosteroids, tricyclic antidepressants, and atypical antipsychotics\n* Surgery scheduled for the trial duration period, except for minor, non-gastrointestinal surgical procedures at the discretion of the investigator\n* Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial\n* Serum prostate specific antigen (PSA) \\> 3 ng\u002FmL at screening or within 6 months prior to screening\n* Hematocrit \\>50% at screening or within 6 months prior to screening\n* Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the trial, as judged by the investigator",{"count":64,"type":22},15,"INTERVENTIONAL",[67,68],"PHASE1","PHASE2","This clinical interventional study aims to assess whether treatment with with leflutrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian hormone (AMH) or Inhibin B as a positive predictive biomarker.",[71,26],"Infertility Due to Azoospermia","NOT_YET_RECRUITING","2026-04-30",{"date":75,"type":46},"2026-05-06",{"date":77,"type":22},"2026-05-01",{"date":79,"type":22},"2027-08-31",{"name":81,"class":53},"Martin Blomberg Jensen",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":65,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":54},"100397221","spermatogonial-stem-cell-ssc-transplant-and-testicular-tissue-grafting-100397221","NCT04452305","Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting","Inclusion Criteria:\n\n* Male participant at least in Tanner stage 3\n* Previously cryopreserved and stored testicular tissue\u002Fcells (frozen due to an infertility-risking diagnosis or treatment such as chemotherapy or radiation) available for autologous transplantation and grafting\n* Healthy enough to undergo anesthesia\n* Written clearance for the procedure from the patient's hematologist or oncologist to confirm the patient has finished treatment for primary condition and are clear to undergo autologous stem cell transplant\n\nExclusion Criteria:\n\n* Participants considered to be high risk for surgical complications\n* Participants with a history of leukemia, lymphoma or testicular cancer or a cancer that likely involved testicles at the time of testicular tissue collection\n* Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.",{"count":89,"type":22},10,[91],"NA","Spermatogonial stem cell transplantation through ultrasound guided rete testis injection and testicular tissue grafting will be performed for participants who have frozen testicular tissue prior to gonadotoxic therapy. The purpose of this study is to test the safety and feasibility of these transplant technologies and restore fertility for these participants.",[26,94,95],"Cancer","Autoimmune Disorder",[97,98,99,100],"spermatogonial stem cells","testis","fertility","oncofertility","2026-04-18",{"date":103,"type":46},"2026-04-22",{"date":105,"type":46},"2023-11-10",{"date":107,"type":22},"2030-05-31",{"name":109,"class":53},"University of Pittsburgh",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":65,"phases":118,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":54},"100508702","phase-3-improvement-of-reproductive-function-in-men-with-spinal-cord-injury-sci-100508702","NCT05903859","Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)","Inclusion Criteria:\n\n1. Subject has a traumatic spinal cord injury.\n2. Subject is male and is 18 years or older.\n\nExclusion Criteria:\n\n1. Subject has been injured less than 1 year.\n2. The subject is known to be azoospermic.\n3. The subject has an indwelling urethral Foley catheter.\n4. Subject is under the age of 18 years.\n5. Subject has an unstable medical condition including, but not limited to, Crohn's disease, ulcerative colitis, colon cancer or has other conditions deemed to be exclusionary per the Investigator.\n6. Subject is unable to consent or comprehend the procedures and their implications.\n7. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc.\n8. Any subject for whom the procedure or medication is otherwise contraindicated.\n9. Subject has hypersensitivity to probenecid.\n10. Subject has a history of uric acid kidney stones and\u002For peptic ulcer.\n11. The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment.\n12. The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines.\n13. The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.",{"count":117,"type":22},90,[119],"PHASE3","This is a study of infertility which often occurs in men with spinal cord injury. Most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. This study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. The medicine is called probenecid.",[26],[123],"Spinal cord injury","2026-02-26",{"date":126,"type":46},"2026-03-02",{"date":128,"type":46},"2024-01-18",{"date":130,"type":22},"2028-12-31",{"name":132,"class":53},"University of Miami",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":65,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":54},"100385403","experimental-round-spermatid-injection-rosi-to-treat-infertile-couples-100385403","NCT04298255","Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples","ROSI","Inclusion Criteria:\n\n* Males with no elongated spermatids or spermatozoa present but with round spermatids present on TESE (Testicular Sperm Extraction)\n* Male diagnosed with non-obstructive Azoospermia\n* Male partner ≥18\n* Female partner greater than 18 years of age and less than 38 years of age or Anti Mullerian Hormone (AMH) greater than 2 ng\u002Fml.\n\nExclusion Criteria:\n\n* Males with obstructive azoospermia\n* Males with presence an adequate number of elongated spermatids or spermatozoa",{"count":141,"type":22},50,[91],"The purpose of this research study is to evaluate if special types of cells called round spermatids can be gathered from men with non-obstructive azoospermia and used (in absence of elongated spermatids and spermatozoa) to reliably and effectively create pregnancy with a procedure called Round Spermatid Injection (ROSI). This process is similar to In Vitro Fertilization, or 'IVF'. In addition, this study wants to test the safety of ROSI and see what effects (good and bad) it has on embryo created from this method.",[26],[146,34],"IVF","2025-09-15",{"date":149,"type":46},"2025-09-16",{"date":151,"type":46},"2020-08-24",{"date":153,"type":22},"2026-07",{"name":155,"class":53},"Wake Forest University Health Sciences",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":163,"sex":164,"minAge":4,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":54},"100410745","cell-free-preimplantation-genetic-testing-100410745","NCT04628507","Cell Free Preimplantation Genetic Testing","Evaluation of Cell Free Preimplantation Genetic Testing","Inclusion Criteria:\n\n* Patients undergoing IVF electing to utilize LifeView testing (PGT) will be offered participation in this study.\n\nExclusion Criteria:\n\n* None",true,"ALL",{"count":166,"type":22},200,"This study aims to develop preimplantation genetic testing methods from embryo culture media (cell free). Genetic testing of culture media will be compared to conventional methods based on embryo biopsies.",[169,26],"Infertility, Female",[171,172],"PGT","Noninvasive","2025-08-19",{"date":175,"type":46},"2025-08-26",{"date":177,"type":22},"2026-06-11",{"date":179,"type":22},"2027-12-11",{"name":181,"class":182},"Genomic Prediction Inc.","INDUSTRY",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":190,"targetDuration":4,"studyType":65,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":54},"100589114","the-effect-of-supplementation-with-fish-oil-epax-evolve-05-on-sperm-quality-100589114","NCT06950203","The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality","A Randomised, Double Blinded Study to Determine the Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality in Healthy Men.","Inclusion Criteria:\n\n1. Men aged 18-55\n2. Referred for or claiming a semen analysis.\n3. Willing to have at least 2 days abstinence of sexual activity prior to a sperm sample being taken.\n4. Reduced semen quality defined as:\n\n   • Progressive motility: \\\u003C30%\n5. Willing to refrain from omega-3\u002Fcod liver oil supplementation during the study. Use of other supplements is allowed.\n\n   \\-\n\nExclusion Criteria:\n\n1. Known allergy to fish products\n2. Historically, known, or suspected bacterial infection in reproductive organs\n3. Varicocele suspected from physical examination\n4. Azoospermia\n5. Diagnosis of diabetes (type 2)\n6. Diagnosis of Crohn´s Disease\n7. Inferior semen quality due to medical reasons, such as cryptorchidism (via questionnaire\u002Fmedical records) -",{"count":21,"type":22},[91],"The study will enrol men that have a poor sperm quality. They will take either a placebo or fish oil capsule (2 per day) for 3 months. At the beginning and end of the study the participant will be asked for a sperm sample for measuring quality parameters.",[26],[195,196,197,99,198],"VLCFA","VLC-PUFA","Very long chain polyunsaturated fatty acids","supplement","2025-04-29",{"date":201,"type":46},"2025-05-01",{"date":203,"type":46},"2025-03-10",{"date":205,"type":22},"2026-12-20",{"name":207,"class":182},"Epax Norway AS",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":163,"sex":17,"minAge":18,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":65,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":54},"100512332","prospective-study-on-power-prenatal-vitamins-for-males-on-yo-score-at-home-sperm-test-results-100512332","NCT05951075","Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results","The Impact of Power Prenatal Supplements for Males on YO Score At-home Sperm Test Results Over a Three Month Course","Inclusion Criteria:\n\n* Male patients with at-home YO Sperm score between 20-40, corresponding to a MSC (motile sperm concentration) between 14-39 motile million \u002F ml\n* Ages 18-50\n* Living in USA or Canada\n\nExclusion Criteria:\n\n* Active smokers\n* A known cause of male infertility (eg diagnosed varicocele, hormonal issue, history of testicular surgery, history of chemotherapy, etc)\n* Not concurrently taking other forms of prenatal vitamins","50 Years",{"count":217,"type":22},174,[91],"Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis.\n\nThere are now options to assess sperm quality with at-home sperm analysis kits, including an FDA approved Yo Sperm kit (https:\u002F\u002Fyospermtest.com\u002F) which analyzes the motile sperm concentration \\[concentration (millions \u002F ml) x motility (Percentage motile)\\] and sperm quality (YO Score) which compares your results to laboratory standards and to other men who have fathered children.\n\nThe effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated. Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility.\n\nThe life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect.\n\nThe investigators hypothesize that a 90 day course of the \"Power Prenatal for Sperm\", a male fertility supplement by Bird\\&Be (https:\u002F\u002Fbirdandbe.com\u002Fthe-power-prenatal-for-sperm) will improve sperm quality (YO Score) after taking the supplements.",[221,26],"Spermatogenesis and Semen Disorders","2025-04-05",{"date":224,"type":46},"2025-04-08",{"date":226,"type":46},"2023-11-01",{"date":228,"type":22},"2026-12-31",{"name":230,"class":182},"The Bird and Be Co Inc",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":163,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":65,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":245,"leadSponsor":246,"locationsCount":54},"100470816","power-prenatal-supplements-for-sperm-quality-100470816","NCT05410782","Power Prenatal Supplements for Sperm Quality","A Three Month Course of Power Prenatal Supplements to Improve Sperm Quality in Male-factor Infertility Patients","Inclusion Criteria:\n\n* Male\n* Age 18-45 years old\n* Experiencing infertility\n* A recent semen analysis confirming low count, motility or morphology (at least 1 of 3) - within last 3 months\n\n  1. Low concentration: \\\u003C 15 Million \u002F mL\n  2. Low Motility: Progessive Motility \\\u003C 30%\n  3. Morphology: Strict criteria: Normal forms \\\u003C 4% Reference: WHO 2020 6th edition: https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fi\u002Fitem\u002F9789240030787\n\nExclusion Criteria:\n\n* No diagnosed varicocele\n* Younger than 18 years old\n* Older than 45 years old\n* Currently taking any form of antioxidant supplements(in last 3 months) besides a general multivitamin","45 Years",{"count":141,"type":22},[91],"Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis \\[WHO 2020 - https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fi\u002Fitem\u002F9789240030787\\]. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated (https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F30462179). Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility. The life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect.\n\nThe investigators hypothesize that a 90 day course of the \"Power Prenatal for Sperm\", a male fertility supplement by Bird\\&Be (https:\u002F\u002Fbirdandbe.com\u002Fthe-power-prenatal-for-sperm) will improve sperm quality based on semen analysis results prior to, and after taking the supplements.",[221,26],{"date":224,"type":46},{"date":226,"type":46},{"date":228,"type":22},{"name":230,"class":182},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":163,"sex":17,"minAge":18,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":65,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":54},"100580788","phase-1-spermatogonial-differentiation-via-testicular-organoid-100580788","NCT06841861","Spermatogonial Differentiation Via Testicular Organoid","A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid","SDTO","Inclusion Criteria: Group 1 (Fertile Control)\n\n* Male sex of reproductive age (between 18 - 60 years old).\n* Evidence of fertility or normal spermatogenesis.\n* Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.\n\nInclusion Criteria: Group 2 and 3 (Infertile)\n\n* Male sex of reproductive age (between 18 - 60 years old).\n* Males with evidence of \\>1 year of infertility.\n* Posesses diagnosis of azoospermia is on clinical evaluation.\n* Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.\n\nExclusion Criteria:\n\n\\- The lack of diagnosis of fertility or infertility, and lack of testicles.","60 Years",{"count":257,"type":22},100,[67,68],"Purpose:\n\nThis clinical trial aims to explore the potential for human sperm production in vitro by sustaining a laboratory-cultured adult testicular environment. It also seeks to identify genetic factors contributing to human sterility and failed spermatogenesis. The study's primary objectives include:\n\n1. Identifying genomic markers associated with sterility and failed spermatogenesis.\n2. Developing an ex vivo (outside the body) testis \"organ-on-a-chip\" (\"iTestis\") to support stem cell cultivation.\n3. Determining whether human spermatogenesis can be re-created in vitro using stem cells nurtured in the iTestis model.\n\nStudy Description:\n\nResearchers will analyze the genomic profiles of fertile and sterile male participants to map genetic abnormalities associated with sterility. Using testicular and skin tissue samples from participants, spermatogonial stem cells and pluripotent stem cells will be isolated and utilized to construct the ex vivo iTestis. This system will integrate genomic insights and prior research to foster human spermatogenesis outside the body.\n\nParticipant Involvement:\n\nParticipants will provide the following samples:\n\n* Blood sample for serum analysis.\n* A skin tissue biopsy.\n* Testicular tissue, obtained through fine needle aspiration (FNA) or testicular sperm extraction (TESE), as part of a routine procedure.\n\nAll procedures will be conducted by the principal investigator and qualified research staff, ensuring participant safety and adherence to ethical guidelines.",[26,261,262],"Gene Abnormality","Sterility, Male","2025-02-20",{"date":265,"type":46},"2025-02-24",{"date":267,"type":46},"2024-03-28",{"date":269,"type":22},"2027-01-01",{"name":271,"class":182},"CellARTs Inc.",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":164,"minAge":18,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100557514","aftificial-inteligence-in-assisted-reproductive-techniques-to-assess-oocyte-quality-and-embryo-ploidy-100557514","NCT06539104","Aftificial Inteligence in Assisted Reproductive Techniques to Assess Oocyte Quality and Embryo Ploidy","Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality and Embryo Ploidy Evaluated by Artificial Intelligence (SMARTAI Study)","SMARTAI","Inclusion Criteria:\n\n* Intracytoplasmatic Sperm Injection\n* Preimplantation genetic testing\n* Time lapse embryo record\n* Singned informed consent\n\nExclusion Criteria:\n\n* Gynecological diseases\n* Genetical diseases of parents","49 Years",{"count":282,"type":22},1000,"The assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation. Artificial intelligence (AI) will be applied to establish the complex oocyte quality, embryo ploidy and pregnancy success probability from the sequence of data, starting with the recording of the meiotic spindle in polarized light, through paternal factors up to the time lapse recording of early embryo development. This strategy should reduce the cost of fertility treatment thanks to increased efficiency in choosing the most promising candidates and reducing the need for costly laboratory analyses.",[27,169,26,285],"Infertility Unexplained",[287,288,146,289,290,291,292],"infertility","humant oocyte","arteficial inteligence","Sperm count","meiotic spindle","time lapse","2025-01-17",{"date":295,"type":46},"2025-01-22",{"date":297,"type":46},"2024-01-05",{"date":299,"type":22},"2028-03-31",{"name":301,"class":53},"Charles University, Czech Republic",4,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":163,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":311,"conditions":312,"keywords":317,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":328},"100487584","the-association-of-gut-microbiota-and-spermatogenic-dysfunction-100487584","NCT05628987","The Association of Gut Microbiota and Spermatogenic Dysfunction","Inclusion Criteria:\n\n* Aged 18 to 45 years, males\n* Body Mass Index (BMI):18.5-29.9 kg\u002Fm\\^2\n* After an abstinence period of 2-7 days, two abnormal semen analysis, the absence of spermatozoa from both replicates will be included in the azoospermia group, the total sperm number (\\\u003C39\\*10\\^6 per ejaculate) or the sperm concentration ( \\\u003C 15 \\* 10\\^6 per ml) will be oligozoospermia group, the progressive motility (PR) (\\\u003C 32%) will be asthenozoospermia group; the percentage of morphologically normal spermatozoa (\\\u003C4%) will be teratozoospermia group\n* Willing to provide feces, urine, blood samples, able to complete study questionnaires aimed at lifestyle factors (cigarette smoking, high temperature environment and others ) and other data collection instruments (e.g. physical activity, food frequency questionnaire, stress and others)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 45 years\n* History of Zocanidin, Vitamin E, antibiotics, clyster, gastrointestinal endoscope in the past 30 days, or other drugs known to interact with semen quality or gut microbiota, history of high alcohol consumption (liquor over 200 ml, beer over 1000 ml) in the past 7 days or drinking every week in the past month\n* A known genetic cause of male factor spermatogenesis dysfunction, including chromosomal or gene disorders (e.g. Y chromosome deletions, CFTR mutation)\n* History of male reproductive system (e.g. testis, epididymis, seminiferous duct and others) damage, surgery, tumor or infection\n* History of Crohn's disease, ulcerative colitis, acute gastrointestinal disease, renal failure, liver cirrhosis, hypoplasia, X-rays exposure and other diseases related to spermatogenic dysfunction, history of intestinal gastrointestinal surgery (exclude appendix surgery)\n* History of psychoses or other mental conditions that would result in cognitive impairment and inability to participate in any part of this study including the informed consent process",{"count":310,"type":22},306,"This is a multicenter, case-control study that aims to investigate the relationship between microbiota and sperm quality via stool, blood, and urine microbiome, metabolomics, and collected clinical metadata. The results of the spermatogenic dysfunction, including aspermia, oligozoospermia, asthenozoospermia, and teratozoospermia, will be compared to normal basic semen analysis utilizing the World Health Organization (WHO) semen analysis procedure 5th edition.",[26,313,314,315,316],"Azoospermia","Oligozoospermia","Asthenozoospermia","Teratozoospermia",[31,26,318],"Sperm","2024-07-22",{"date":321,"type":46},"2024-07-24",{"date":323,"type":46},"2023-02-20",{"date":325,"type":22},"2025-06-30",{"name":327,"class":53},"Zhujiang Hospital",3,{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":164,"minAge":18,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":65,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":354},"100545660","study-of-the-zymt-sperm-selection-method-and-its-effect-on-embryo-ploidy-100545660","NCT06384794","Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.","ZYMOT2","Inclusion Criteria:\n\n* Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test for Aneuploidy).\n* Males over 18 years of age whose semen sample meets the basic conditions predetermined by the ZyMōt Multi 850µL chip.\n* Fresh semen samples.\n* Embryos are to be deposited in a time-lapse incubator.\n* Women over 37 years of age who have obtained in follicular puncture a number of MII oocytes greater than or equal to 4.\n\nExclusion Criteria:\n\n* Males with severe asthenozoospermia (\\\u003C10% progressively motile spermatozoa), globozoospermia (spermatozoa with morphological alterations and lack of acrosome) and\u002For azoospermia (absence of spermatozoa in the ejaculate).\n* Seminal samples obtained by testicular biopsy.\n* Samples incubated with calcium ionophore.\n* Males and females with previously known abnormal karyotype.\n* Oocytes coming from the oocyte donation program.",{"count":21,"type":22},[91],"It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.",[26,340],"Sperm Count, Low",[342,343,344,345],"ZyMöt","Sperm fragmentation","Embryo development","Euploidy","2024-04-25",{"date":348,"type":46},"2024-04-29",{"date":350,"type":46},"2023-06-29",{"date":228,"type":22},{"name":353,"class":53},"Instituto Valenciano de Infertilidad, IVI VALENCIA",2]