[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"male-infertility\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:male-infertility":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,46,75,95,125,156,190,220,256,277,300,322,348,373,407,435,459,487,511,547,572],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100642491","single-infrapubic-versus-bilateral-subinguinal-microsurgical-varicocelectomy-100642491",false,"NCT07650955","Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy","Single Infrapubic Versus Bilateral Subinguinal Approaches for Bilateral Microsurgical Varicocelectomy: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Male patients aged 18 to 45 years.\n* Clinically palpable bilateral varicocele, grade II or grade III.\n* Diagnosis confirmed by color Doppler ultrasound.\n* Infertility for at least 12 months and\u002For abnormal semen analysis.\n* Female partner evaluation performed or planned to exclude major uncorrected female-factor infertility.\n* Patient fit for surgery and anesthesia.\n* Written informed consent provided by the participant.\n\nExclusion Criteria:\n\n* Subclinical varicocele detected only by Doppler ultrasound.\n* Unilateral varicocele.\n* Recurrent varicocele after previous surgery, embolization, or sclerotherapy.\n* Previous inguinal, scrotal, pelvic, or penile surgery likely to distort surgical anatomy.\n* Associated inguinal hernia, hydrocele, spermatocele, epididymal cyst, or other scrotal condition requiring simultaneous surgery.\n* Azoospermia, especially suspected non-obstructive azoospermia.\n* Active urinary tract or genital infection.\n* Coagulopathy or anticoagulant therapy that cannot be safely interrupted.\n* Severe obesity, defined as body mass index greater than 40 kg\u002Fm², or any anatomical condition preventing safe exposure by either surgical approach.\n* Refusal to participate or inability to complete follow-up.","MALE","18 Years","45 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Bilateral varicocele is commonly treated by microsurgical varicocelectomy. The conventional bilateral subinguinal approach usually requires two separate skin incisions, one on each side. A single midline infrapubic approach may allow bilateral microsurgical repair through one incision and may reduce access-related morbidity.\n\nThis prospective randomized controlled trial will compare single infrapubic microsurgical bilateral varicocelectomy with conventional bilateral subinguinal microsurgical varicocelectomy in adult men with clinically palpable bilateral varicocele. The study will evaluate postoperative pain, analgesic requirement, time to return to normal daily activity, operative time, scar satisfaction, wound complications, recurrence, and other safety outcomes during follow-up.",[27,28],"Bilateral Varicocele","Male Infertility",[30,31,32],"Microsurgical varicocelectomy","Single infrapubic approach","Bilateral varicocele","RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":37},"2026-06-08",{"date":41,"type":21},"2027-05",{"name":43,"class":44},"Beni-Suef University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100628035","development-of-an-ai-platform-for-the-analysis-of-sperm-and-prediction-of-their-clinical-potential-100628035","NCT07456397","Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential","Development and Validation of an Artificial Intelligence Platform for the Analysis of Sperm Samples and Prediction of Their Clinical Potential","Spermy01","Male participants:\n\nInclusion Criteria:\n\n* Ability to provide a semen sample via masturbation\n* Semen sample intended for use in an IVF\u002FICSI cycle\n\nExclusion Criteria:\n\n* Current diagnosis of a sexually transmitted infection (STI)\n* Previous diagnosis of hepatitis A, B, C, D, or HIV\n* Prior participation in this study\n* Participation in a clinical trial involving an intervention within the last 3 months\n\nFemale participants:\n\nInclusion Criteria:\n\n* Urdengoing an IVF\u002FICSI cycle with partner or donor semen\n\nExclusion Criteria:\n\n* Prior participation in this study\n* Participation in a clinical trial involving an intervention within the last 3 months","ALL","60 Years",{"count":57,"type":21},500,"OBSERVATIONAL","Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to develop an artificial intelligence platform for the analysis of sperm samples and prediction of their clinical potential, in 500 semen samples, in an in vitro study over 24 months.",[61,62,63,28,64],"Infertility (IVF Patients)","ICSI","IVF Outcomes","Reproductive Issues","2026-06-10",{"date":67,"type":37},"2026-06-12",{"date":69,"type":37},"2026-03-18",{"date":71,"type":21},"2028-02",{"name":73,"class":44},"Fecundis Lab SL",5,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":45},"100583744","male-infertility-and-assisted-reproductive-technologies-research-biobank-100583744","NCT06880302","Male Infertility and Assisted Reproductive Technologies Research Biobank","MARK","Inclusion Criteria:\n\n* Males providing testicular tissue, sperm, semen samples, discarded sperm preps for IUI\u002FIVF\u002FICSI or the sperm recipient for those utilizing donor sperm, for cryopreservation at the respective site(s) for either clinical use or preservation\n\nExclusion Criteria:\n\n* Samples that are quarantined or in isolation dewars for infectious diseases",{"count":83,"type":21},1000,"The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART).",[28,61],"2026-06-01",{"date":88,"type":37},"2026-06-02",{"date":90,"type":37},"2025-03-04",{"date":92,"type":21},"2032-12",{"name":94,"class":44},"Reproductive Medicine Associates of New Jersey",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":54,"minAge":103,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":45},"100640272","effectiveness-of-live-motile-sperm-sorting-device-on-ivf-outcomes-in-advanced-paternal-age-100640272","NCT07605182","Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age","Evaluation of the Effectiveness of Live Motile Sperm Sorting Device on In Vitro Fertilization Outcomes in Advanced Paternal Age Group","IVF","Inclusion Criteria:\n\n* Male partners aged ≥ 40 years\n* Semen analysis: volume ≥ 1.4 mL, sperm concentration ≥ 6 million\u002FmL, progressive motility (PR) ≥ 20% after 3-5 days of abstinence.\n* Female partners with ≥ 5 mature (MII) oocytes retrieved.\n* Couples undergoing ICSI with PGT-A and elective single embryo transfer (eSET).\n* Willingness to participate and sign informed consent.\n\nExclusion Criteria:\n\n* Azoospermia, surgical sperm retrieval, or use of cryopreserved sperm.\n* Female uterine or ovarian conditions severely affecting IVF outcomes.\n* Use of donor sperm or donor oocytes","40 Years",{"count":105,"type":21},378,[24],"Male infertility contributes significantly to infertility, particularly in advanced paternal age men where sperm DNA fragmentation is increased. Conventional density gradient centrifugation may induce oxidative stress and sperm damage. LensHooke® CA0 is a centrifugation-free sperm sorting device designed to improve sperm quality and reduce DNA fragmentation. This prospective comparative study evaluates the effectiveness of CA0 versus conventional density gradient centrifugation on post-processing sperm quality, DNA fragmentation index, blastocyst formation, euploid embryo rate, and clinical pregnancy outcomes in IVF\u002FICSI cycles involving men aged 40 years or older",[28,109,110],"Advanced Paternal Age","Assisted Reproductive Technology",[112,113,62,114],"DNA fragmentation","Advanced paternal age","LensHooke CA0","NOT_YET_RECRUITING","2026-05-19",{"date":118,"type":37},"2026-05-22",{"date":120,"type":21},"2026-05-05",{"date":122,"type":21},"2027-12-30",{"name":124,"class":44},"Vietnam Military Medical University",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":45},"100639084","selective-extended-venous-stripping-versus-standard-microsurgical-varicocelectomy-for-varicocele-related-male-infertility-100639084","NCT07605351","Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility","Selective Extended Microsurgical Venous Stripping Versus Standard Microsurgical Subinguinal Varicocelectomy in Infertile Men With Abnormal Semen Parameters: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Male patients aged 18 to 50 years.\n* Couple infertility for at least 12 months.\n* Clinically palpable grade I to III varicocele confirmed by physical examination.\n* Abnormal semen parameters documented on at least two semen analyses performed 2 to 4 weeks apart according to World Health Organization laboratory standards.\n* Female partner evaluation completed or planned, with no untreated severe female factor that would make natural conception impossible.\n* Willingness to comply with postoperative follow-up at 3, 6, and 12 months.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Azoospermia or cryptozoospermia, defined as absence of sperm in the native ejaculate on at least two baseline semen analyses, including cases in which sperm are detected only after centrifugation.\n* Known clinically significant chromosomal or genetic abnormality that independently explains severe male infertility, when identified before enrollment.\n* Previous varicocelectomy of the index side.\n* Previous inguinal, scrotal, or retroperitoneal surgery that may alter spermatic cord anatomy.\n* Subclinical varicocele only.\n* Isolated scrotal pain with normal semen parameters.\n* Hypogonadotropic hypogonadism requiring hormonal induction therapy.\n* Testosterone therapy within the previous 6 months.\n* Use of anti-estrogens, gonadotropins, or aromatase inhibitors within the previous 3 months.\n* Active genitourinary infection.\n* Testicular tumor or history of testicular cancer.\n* Severe systemic disease contraindicating surgery or anesthesia.\n* Inability to provide informed consent.\n* Inability or unwillingness to complete follow-up.","50 Years",{"count":134,"type":21},160,[24],"Varicocele is a common correctable cause of male infertility and may be associated with abnormal semen parameters, impaired testicular function, and scrotal discomfort. Microsurgical subinguinal varicocelectomy is a commonly used surgical approach because it allows careful preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels under magnification. However, persistent or recurrent varicocele may still occur after surgery, possibly because of missed or persistent venous channels.\n\nThis randomized controlled trial will compare two surgical techniques in infertile men with clinically palpable varicocele and abnormal semen parameters. Participants will be randomly assigned to either microsurgical subinguinal varicocelectomy with selective extended venous stripping or standard microsurgical subinguinal varicocelectomy with conventional vein ligation and division.\n\nThe main purpose of the study is to determine whether selective extended venous stripping reduces the rate of clinically and Doppler-confirmed persistent or recurrent varicocele at 12 months after surgery compared with the standard microsurgical technique. The study will also compare semen parameter improvement, pain improvement in participants with baseline pain, pregnancy outcomes, operative time, postoperative complications, and the need for additional treatment during 12 months of follow-up.",[138,28],"Varicocele",[138,28,140,141,142,143,144,145,146,147],"Microsurgical Varicocelectomy","Subinguinal Varicocelectomy","Venous Stripping","Semen Analysis","Scrotal Doppler Ultrasound","Varicocele Recurrence","Abnormal Semen Parameters","Pregnancy Outcome","2026-05-18",{"date":118,"type":37},{"date":151,"type":21},"2026-06-15",{"date":153,"type":21},"2028-06-15",{"name":155,"class":44},"Benha University",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":163,"sex":164,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100636796","comparison-of-two-types-of-calcium-ca-ionophore-treatments-for-oocyte-activation-in-cases-of-suboptimal-fertilization-potential-100636796","NCT07570342","Comparison of Two Types of Calcium (Ca²⁺) Ionophore Treatments for Oocyte Activation in Cases of Suboptimal Fertilization Potential","(Ca²⁺)","Inclusion Criteria:\n\n1. Patients undergoing assisted reproductive technology cycles when ICSI is indicated.\n2. Patients with a minimum of 3 MII oocytes after denudation.\n3. Maternal age 18-43 years old.\n4. PGT-A cycles with only trophectoderm biopsies on day 5\u002F6\u002F7.\n5. BMI\\\u003C35.\n6. Fresh and frozen immotile ejaculated sperm.\n7. Fresh and frozen TESE sperm (motile and immotile).\n8. Globozoospermia.\n\n10\\. Couples undergoing ICSI due to poor fertilization history (≤30%), or previous fertilization failure.\n\nExclusion Criteria:\n\n1. PGT-M\u002FSR cycles.\n2. Fresh and frozen motile ejaculated \u002F FNA sperm.\n3. IVF inseminated oocytes.",true,"FEMALE","43 Years",{"count":167,"type":21},20,[24],"This study aims to investigate the effectiveness and safety of assisted oocyte activation (AOA) using Ca²⁺ ionophores in cases of total fertilization failure (TFF) due to oocyte activation deficiency (OAD). The study will be conducted in two phases: Phase I will compare the fertilization rates of oocytes exposed to two types of Ca²⁺ ionophore treatments- Ionomycin solution and commercially available CultActive-against a control group without calcium ionophore treatment. Phase II will assess whether an additional injection of CaCl2, prior to exposure to the chosen ionophore from Phase I, further improves fertilization outcomes. The goal is to identify the optimal AOA protocol for improving fertilization rates and to evaluate the safety and efficacy of this approach in relation to ploidy, with a focus on ensuring normal pre-implantation embryo development.",[62,171,28,172],"Testicular Sperm Extraction in Azoospermic Patients","PGT-A",[62,172,174,175,176,177,178,179,180],"artificial oocyte activation","AOA","calcium ionophore","ionomycin","TESE","Immotile sperm","Failed fertilization","2026-05-06",{"date":183,"type":37},"2026-05-11",{"date":185,"type":21},"2026-04-30",{"date":187,"type":21},"2026-12-31",{"name":189,"class":44},"ART Fertility Clinics LLC",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100632766","intratesticular-artery-resistive-index-changes-after-varicocelectomy-100632766","NCT07517952","Intratesticular Artery Resistive Index Changes After Varicocelectomy","Evaluation of Changes in Intratesticular Artery Resistive Index Following Varicocelectomy and Their Correlation With Semen Parameters and Testosterone Levels","Inclusion Criteria:\n\n* Infertile male patients with clinically palpable varicocele (Grade I to III).\n\nExclusion Criteria:\n\n* Extremes of age (pediatric or geriatric populations).\n* History of previous scrotal surgery or trauma.\n* Active urogenital infection (e.g., epididymo-orchitis).\n* History of testicular torsion.\n* Any comorbidity that may independently affect testicular vascularity or hemodynamics.","65 Years",{"count":20,"type":21},[24],"This study aims to evaluate how blood flow inside the testicles changes after surgery to correct a varicocele, and whether these changes correlate with improvements in semen quality and testosterone levels.\n\nVaricocele is a common, treatable cause of male infertility that can negatively affect testicular function by altering blood flow and temperature. While surgery (varicocelectomy) often improves fertility, doctors are continually looking for ways to predict which patients will benefit the most from the procedure. This study uses scrotal color Doppler ultrasound to measure the Intratesticular Artery Resistive Index (RI), which is an indicator of blood flow resistance and microvascular health, before and after surgery.\n\nResearchers will recruit 40 infertile men with clinically palpable varicoceles. Participants will undergo a baseline evaluation that includes a physical exam, semen analysis, a blood test for total testosterone, and a specialized ultrasound to measure the RI under different physical conditions (lying down, standing, and during a Valsalva maneuver\u002Fbearing down).\n\nAll participants will then undergo a microscopic sub-inguinal varicocelectomy, which is the standard microsurgical treatment. Three months after the surgery, participants will return for follow-up testing to repeat the semen analysis, testosterone blood test, and ultrasound.\n\nThe main goal of the study is to determine if pre-operative RI measurements can serve as an early, reliable predictor of surgical success, specifically looking at the recovery of testicular function, sperm parameters, and hormonal levels.",[138,28,202],"Secondary Hypogonadism",[204,205,206,207,208,209,210],"Varicocelectomy","Resistive Index","Intratesticular Artery","Semen Parameters","Testosterone","Color Doppler Ultrasonography","Microscopic Sub-inguinal Varicocelectomy","2026-04-02",{"date":213,"type":37},"2026-04-08",{"date":215,"type":21},"2026-05",{"date":217,"type":21},"2027-06",{"name":219,"class":44},"Assiut University",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":238,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":45},"100621793","effect-of-daily-intake-of-gazpacho-on-semen-quality-and-oxidative-stress-100621793","NCT07375238","Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress","Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress in Men With Altered Semen Parameters: A Randomized Controlled Study","G-OXSEM","Inclusion Criteria:\n\n* Men aged 18 to 45 years\n* Andrological profile including altered semen parameters such as oligozoospermia, asthenozoospermia and\u002For teratozoospermia (O±A±T)\n* No clinical indication for sperm DNA fragmentation testing or advanced sperm selection techniques\n* Willingness and ability to comply with the study protocol, including adherence to a standardized Mediterranean diet\n* Signed and dated written informed consent form\n\nExclusion Criteria:\n\n* Use of antioxidant supplements during the three months prior to study start.\n* Active smokers or men who have stopped smoking within the last three months.\n* Diagnosis of azoospermia, leucocytospermia or necrozoospermia.\n* Presence of severe systemic diseases or chronic conditions that could interfere with semen quality or adherence to the study.\n* Known allergy or intolerance to any ingredient of the gazpacho used in the study.\n* Any medical, psychological or social condition that, in the investigator's judgement, could compromise the subject's ability to participate fully or comply with the protocol requirements.\n* Simultaneous participation in another clinical study.",{"count":229,"type":21},80,[24],"The goal of this clinical trial is to learn whether drinking a daily serving of gazpacho can improve semen quality in men with reduced sperm quality. The study will also examine how this dietary intervention affects oxidative stress and whether it is well tolerated.\n\nThe main questions this study aims to answer are:\n\n* Does daily consumption of gazpacho improve semen quality in men with altered semen parameters?\n* Does this dietary intervention affect levels of oxidative stress in semen?\n* Is daily gazpacho intake feasible and well tolerated as part of a Mediterranean diet?\n\nResearchers will compare a Mediterranean diet plus daily gazpacho intake with a Mediterranean diet alone to determine whether adding gazpacho provides additional benefits for male reproductive health.\n\nParticipants will:\n\n* Follow a standardized Mediterranean diet for 12 weeks\n* Drink 330 mL of gazpacho every day or follow the diet without gazpacho\n* Provide semen samples at the start of the study and after 12 weeks\n* Complete a short diary to record adherence to the dietary intervention\n* Be followed for up to 18 months to record reproductive outcomes",[28,233,234,235,236,237],"Oxidative Stress","Subfertility","Oligozoospermia","Asthenozoospermia","Teratozoospermia",[239,240,241,242,243,244,245,246],"Mediterranean diet","Gazpacho","sperm quality","Male infertility","Altered semen parameters","oxidative stress","OxiSperm II","Randomized trial","2026-03-11",{"date":249,"type":37},"2026-03-13",{"date":251,"type":37},"2026-03-02",{"date":253,"type":21},"2029-09-01",{"name":255,"class":44},"Ginefiv",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":163,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":264,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},"100573142","efficacy-and-safety-of-a-new-sperm-capacitation-method-100573142","NCT06742437","Efficacy and Safety of a New Sperm Capacitation Method","Efficacy and Safety of a New Sperm Capacitation Method: a Prospective in Vitro Study on Semen Samples","HyperSperm01","Inclusion Criteria:\n\n* Ability to provide a semen sample via masturbation\n\nExclusion Criteria:\n\n* Current diagnosis of a sexually transmitted infection (STI)\n* Previous diagnosis of hepatitis A, B, C, D, or HIV\n* Prior participation in this study\n* Participation in a clinical trial involving an intervention within the last 3 months",{"count":265,"type":21},300,"Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.",[64,28,236,235,237],"2026-02-24",{"date":270,"type":37},"2026-02-27",{"date":272,"type":37},"2025-01-14",{"date":274,"type":21},"2026-06",{"name":73,"class":44},4,{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":54,"minAge":284,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":22,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":298,"locationsCount":45},"100559232","live-birth-rate-between-icsi-and-aoa-and-icsi-alone-in-patients-with-severe-teratospermia-100559232","NCT06561451","Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia","A Randomized Control Trial to Compare the Live Birth Rate Between Intracytoplasmic Sperm Injection and Artificial Oocyte Activation and Intracytoplasmic Sperm Injection Alone in Patients With Severe Teratospermia","Inclusion Criteria:\n\n1. Age of women 20-37 years at the time of ovarian stimulation for ICSI\n2. At least three matured oocytes Severe teratozoospermia: defined as abnormal sperm morphology ranging between 99-100%, including globozoospermia and tapered-head.\n\nExclusion Criteria:\n\n1. Presence of hydrosalpinx which is not surgically treated\n2. Undergoing preimplantation genetic testing\n3. Recurrent pregnancy loss (defined as two or more previous spontaneous pregnancy losses)\n4. Known uterine abnormality (e.g., uterine congenital malformation; untreated uterine septum, adenomyosis, or submucous myoma; endometrial polyps; or intrauterine adhesions)\n5. Abnormal parental karyotyping, or Medical conditions that assisted reproductive technology or pregnancy is contraindicated","20 Years","37 Years",{"count":287,"type":21},208,[24],"The goal of this clinical trial is to compare the live birth rate between intracytoplasmic sperm injection (ICSI) and artificial oocyte activation (AOA) vs intracytoplasmic sperm injection alone in patients with teratospermia. The hypothesis is the live birth rate following ICSI and AOA is significantly higher than that by ICSI alone in patients with teratospermia. This is a randomized controlled trial. Participants will be randomly assigned into one of the two groups:\n\nICSI+AOA group: a single sperm will be injected within 4 hours after the follicular aspiration. All injected oocytes will be incubated in the calcium ionophore A23187 activation solution (C9275-1MG, Sigma, USA) for 10 min, and cultured in the cleavage medium (Cleavage Medium , Cook, United States) under standard conditions.\n\nICSI alone group: a single sperm will be injected within 4 hours after the follicular aspiration.",[28,291],"Teratospermia","2026-01-29",{"date":294,"type":37},"2026-02-02",{"date":296,"type":37},"2024-08-30",{"date":122,"type":21},{"name":299,"class":44},"ShangHai Ji Ai Genetics & IVF Institute",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":45},"100476095","platelet-rich-plasma-testis-treatment-for-infertile-men-100476095","NCT05479474","Platelet Rich Plasma Testis Treatment for Infertile Men","Platelet Rich Plasma Testis","Inclusion Criteria:\n\n* Men over the age of 18 diagnosed with NOA and at least one failed TESE, negative mapping or negative biopsy\n\nExclusion Criteria:\n\n\\-",{"count":308,"type":21},10,[24],"Investigate the effect of intratesticular injection of autologous platelet rich plasma (PRP) on sperm retrieval rates and IVF outcomes in infertile men who already underwent a negative sperm retrieval. Currently, there is no alternative treatment after failed TESE. Prior series suggest that intratesticular PRP injections may improve TESE outcomes. We hope to determine whether PRP is an effective treatment for this patient population.",[28,312,313],"Nonobstructive Azoospermia","Azoospermia","2026-01-12",{"date":316,"type":37},"2026-01-13",{"date":318,"type":37},"2023-01-18",{"date":187,"type":21},{"name":321,"class":44},"Stanford University",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":16,"minAge":284,"maxAge":18,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":45},"100619502","probiotics-on-sperm-quality-in-male-infertility-patients-100619502","NCT07345455","Probiotics on Sperm Quality in Male Infertility Patients","Effect of Probiotics on Sperm Quality in Male Infertility Patients","Inclusion Criteria:\n\n* Males aged 20 to 45 years\n* Diagnosis of unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia\n* Sperm concentration \\\u003C 5 x 10\\^6\u002FmL\n* Sperm total motility \\\u003C 40%\n* Sperm morphology (Kruger strict criteria) \\\u003C 4%\n\nExclusion Criteria:\n\n* History of hormonal disorders or epididymo-orchitis\n* Substance abuse, including drugs or excessive alcohol consumption\n* Diabetes mellitus\n* Kidney disease (defined as a doubling of creatinine levels or more)\n* Chronic liver disease\n* Varicocele\n* Current use of medications that interfere with hormones\n* Occupational or environmental exposure to pesticides, heavy metals, or solvents\n* Intake of antioxidant supplements within the past three months\n* Body Mass Index (BMI) of 30 kg\u002Fm\\^2 or higher",{"count":330,"type":21},60,[24],"This randomized, placebo-controlled pilot study aims to evaluate the effects of probiotic supplementation on sperm quality in male patients diagnosed with infertility. Male infertility accounts for approximately 40% of all infertility cases and is closely related to abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, inflammation, and DNA fragmentation are known to impact sperm function and subsequent fertilization potential negatively.\n\nProbiotics are microorganisms that confer health benefits by improving the intestinal microenvironment and regulating immunity. Emerging research suggests that probiotics may reduce oxidative stress and DNA fragmentation in men with asthenozoospermia; however, clinical data on human sperm remains limited. This study seeks to determine whether specific probiotic strains can improve sperm parameters and function in patients with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia.\n\nThe study will enroll 60 male participants aged 20 to 45 who meet specific inclusion criteria, including a sperm concentration of less than 50 million\u002FmL, motility less than 40%, and normal morphology (Kruger) less than 4%. Participants will be randomly assigned to either an experimental group receiving probiotics or a control group receiving a placebo for approximately 100 days.\n\nSemen samples will be collected and analyzed at three time points: before the intervention (Day 0), during the intervention (Day 60), and at the end of the study (Day 100). The primary objective is to assess changes in sperm concentration, motility, and morphology using the Computer-Aided Sperm Analysis (CASA) system. Secondary objectives include evaluating sperm DNA integrity using the Sperm Chromatin Structure Assay (SCSA) by flow cytometry and assessing sperm function via the acrosome reaction assay. The results of this pilot study will help determine the potential therapeutic role of probiotics in the management of male infertility.",[28,235,236,237,334],"Oligoasthenoteratozoospermia",[336,337,338,339,235,236],"Probiotics","Sperm Motility","Sperm DNA","Sperm Function","2026-01-08",{"date":342,"type":37},"2026-01-15",{"date":344,"type":37},"2023-09-16",{"date":187,"type":21},{"name":347,"class":44},"Mackay Memorial Hospital",{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":361,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"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.",{"count":229,"type":21},[24],"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",[359,28,360],"Unexplained Infertility","Sperm DNA Fragmentation",[362,363,364],"royal jelly","unexplained male infertility","sperm dna fragmentation","2026-01-01",{"date":316,"type":37},{"date":368,"type":21},"2026-02-01",{"date":370,"type":21},"2026-08-01",{"name":372,"class":44},"Medipol University",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":380,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":45},"100618380","warfarin-effects-on-male-fertility-after-cardiac-surgery-100618380","NCT07330869","Warfarin Effects on Male Fertility After Cardiac Surgery","Effects of Warfarin Therapy on Semen Quality, DNA Integrity, Hormonal Profile and Molecular Alterations in Male Patients Undergoing Cardiac Surgery: A Prospective Comparative Pilot Study","Inclusion Criteria:\n\n* Male sex, age between 18 and 50 years;\n* Scheduled for elective cardiac surgery (valve replacement, valve repair, or other cardiac procedures) with or without indication to Warfarin therapy;\n* Ability and willingness to provide semen samples at scheduled timepoints;\n* No previous diagnosis of male infertility documented in medical records;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Known severe testicular pathology (for example, untreated high-grade varicocele, history of cryptorchidism, orchiectomy, testicular tumors);\n* Prior chemotherapy or pelvic radiotherapy;\n* Current or recent use of anabolic steroids or other drugs known to strongly impair spermatogenesis;\n* Known endocrine disorders affecting spermatogenesis (for example, untreated hypogonadism, hyperprolactinaemia, severe thyroid disease);\n* Active genitourinary infection at the time of evaluation;\n* Life expectancy less than 12 months or clinical conditions preventing adherence to follow-up.",{"count":381,"type":21},90,"Young male patients undergoing cardiac surgery may require oral anticoagulation with warfarin either lifelong, such as after mechanical valve replacement, or for a limited postoperative period, for example following valve repair or bioprosthetic valve implantation. Although the teratogenic effects of warfarin during pregnancy are well established, prospective clinical data on the potential impact of warfarin therapy on male reproductive health are scarce. This gap is particularly relevant for patients of reproductive age who may have a present or future desire for fatherhood.\n\nWarfarin acts as a vitamin K antagonist by inhibiting the vitamin K epoxide reductase complex, thereby reducing the availability of functional vitamin K. Beyond its role in coagulation, vitamin K is increasingly recognized as an important regulator of spermatogenesis, mitochondrial function, oxidative balance, and steroid hormone synthesis. Experimental and translational evidence suggests that disruption of vitamin K-dependent pathways may impair sperm quality, DNA integrity, mitochondrial bioenergetics, and reproductive hormone homeostasis. In addition, warfarin exposure has been associated with increased oxidative stress and inflammatory responses, both of which are known contributors to male infertility.\n\nDespite these biologically plausible mechanisms, no prospective observational studies have systematically evaluated semen parameters, sperm DNA fragmentation, hormonal profiles, inflammatory markers, and advanced molecular sperm alterations in men exposed to warfarin after cardiac surgery. Consequently, structured andrological assessment is rarely incorporated into routine preoperative counseling or postoperative follow-up in this population.\n\nThis prospective pilot observational study aims to investigate the association between warfarin therapy and male reproductive health in patients undergoing elective cardiac surgery. Male patients aged 18 to 50 years will be enrolled and observed in three cohorts based on clinical indication for anticoagulation: (1) long-term warfarin therapy following mechanical valve replacement; (2) short-term warfarin therapy (approximately three months) after selected cardiac procedures; and (3) a control cohort undergoing cardiac surgery without an indication for long-term oral anticoagulation beyond standard perioperative prophylaxis.\n\nParticipants will undergo comprehensive andrological assessments at baseline and during follow-up up to 12 months after surgery. Evaluations will include semen analysis according to World Health Organization guidelines, assessment of sperm DNA fragmentation, reproductive hormonal profiles, and seminal inflammatory markers. Exploratory analyses will assess mitochondrial function, oxidative stress, and molecular alterations in spermatozoa. Detailed warfarin exposure data, including dose, cumulative exposure, international normalized ratio values, and time in therapeutic range, will be collected to explore potential exposure-response relationships.\n\nAs a pilot study, the primary aims are to assess feasibility and generate preliminary clinical evidence to inform future larger studies. The findings may contribute to improved clinical counseling, fertility preservation strategies, and integration of reproductive health considerations into the multidisciplinary management of young male cardiac surgery patients.",[28,384],"Heart Valve Disease",[386,387,388,389,390,391,392,393,394,395,396,397],"warfarin","male infertility","Semen quality","Sperm DNA fragmentation","Mitochondrial function","Inflammation","Mechanical heart valve","Cardiac surgery","Oral anticoagulation","Vitamin K antagonists","Reproductive hormones","anticoagulation","2025-12-29",{"date":400,"type":37},"2026-01-09",{"date":402,"type":21},"2026-02",{"date":404,"type":21},"2028-06",{"name":406,"class":44},"Città di Lecce Hospital, GVM Care & Research",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":163,"sex":16,"minAge":284,"maxAge":18,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":45},"100436179","efficacy-study-of-a-food-supplement-with-myo-inositol-n-acetyl-cystein-zinc-and-vitamins-on-sperm-dna-fragmentation-100436179","NCT04959864","Efficacy Study of a Food Supplement With Myo-inositol, N-Acetyl-Cystein, Zinc and Vitamins on Sperm DNA Fragmentation","Double-Blind Randomized Controlled Trial Evaluating the Efficacy of the Food Supplement Isitol® Versus Placebo on the Rate of Abnormal Sperm DNA Fragmentation","Selection Criteria:\n\n* Male patient volunteers aged 20 to 45 years (limits included);\n* Socially insured patient receiving benefits from the French Social Security's health branch\n\nNon-Selection Criteria:\n\n* Patients suffering from infertility of infectious or genetic origin, or from a pathology requiring concomitant medical treatment;\n* Consumption of dietary supplements during the previous 3 months and during the course of the study;\n* Smoking ≥ 5 cigarettes\u002Fday;\n* Alcoholism ≥ 10 drinks (alcohol standard)\u002Fweek ;\n* Body Mass Index (BMI) not between \\[19 and 29\\] (inclusive).\n* Occupation at risk of exposure to carcinogenic, mutagenic and toxic agents for reproduction defined according to articles R.4412-2 2°, R.4412-3 and R.4412-60 of the French Labour Code;\n* Patient unable to give consent;\n* Minors and protected adults, vulnerable persons;\n* Patient participating in another clinical research study\n\nInclusion Criteria:\n\n* Sperm DNA fragmentation rate ≥ 30 %\n\nExclusion Criteria:\n\n* Positive semen culture",{"count":415,"type":21},72,[24],"In industrialised countries, it is estimated that about 15% of couples who wish to have a child are currently facing infertility problems, of which, in half of the cases, an anomaly in sperm quality or at least a factor of male origin is identified. The evaluation of sperm quality in males is based, for the most part, on the micro and macroscopic examination of various parameters (concentration, motility, physical abnormalities of the spermatozoa, etc.). Nevertheless, an increasing number of scientific studies have shown that the quality of sperm DNA, and in particular its fragmentation rate, is also associated with a lower fertilisation rate. The integrity of sperm DNA may be affected by an imbalance in the Red\u002FOx balance leading to uncompensated oxidative stress, and could be restored or improved by dietary hygiene measures and the consumption of specific dietary products. The ISITOL clinical study aims to evaluate the efficacy of a dietary supplement specifically formulated to target the various issues associated with male infertility, and in particular to contribute to the improvement of the sperm DNA fragmentation rate. The efficacy of the dietary supplement Isitol® (GYNOV SAS) on sperm DNA fragmentation rate and other secondary parameters is being evaluated through a single-centre, prospective, randomised, double-blind, interventional vs. placebo clinical study being conducted in France at Laboratoire Drouot (21 Rue Drouot - 75009 Paris - France) and led by Dr. Nino-Guy Cassuto. A total of 72 men aged between 20 and 45 years, with sperm DNA fragmentation rate ≥ 30% and with negative semen culture are recruited. The recruited patients were randomized in a 1:1 scheme into 2 groups (Isitol® treated vs placebo treated).\n\n\\[Results to be reported later\\]",[28],[420,421,422,423,424],"Spermatozoa","DNA Fragmentation","Chromatin Condensation","Food supplement","TUNEL","2025-08-18",{"date":427,"type":37},"2025-08-22",{"date":429,"type":37},"2021-07-07",{"date":431,"type":21},"2026-07",{"name":433,"class":434},"GYNOV","INDUSTRY",{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":16,"minAge":284,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":45},"100590957","effect-of-graminex-on-infertility-related-to-male-accessory-glands-inflammation-100590957","NCT06974175","Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation","Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation. Pilot Study","DEPR_1","Inclusion Criteria:\n\n* Male patients with a diagnosis of MAGI based on clinical and\u002For ultrasonographic criteria.\n\nExclusion Criteria:\n\n* History of cryptorchidism, orchitis, testicular torsion or trauma,\n* Hypogonadism,\n* Occupational chemical exposure,\n* Y chromosome microdeletions, karyotype abnormalities and Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutations,\n* ultrasound testicular volume \\\u003C12 mL,\n* FSH \\>8 mUI\u002FL,\n* fever or drug use within 3 months prior to the enrollment in this study\n* azoospermia.","55 Years",{"count":445,"type":21},50,[24],"Male Accessory Glands Inflammations (MAGI) include inflammatory diseases involving seminal vescicles and the prostate. Patients suffering from them present an impaired fertility because of seminal duct obstruction and alterations of the rheologic and functional parameters of semen, induced by direct microbiological action as well as inflammatory and oxidative damage. Inflammation in seminal plasma can be detected and measured by dosing of inflammatory molecules such as SuPAR and ST2. Treatment of MAGIs include specific antibiotic therapy in addition to use of anti-inflammatory nutraceutics. Deprox HP is a nutraceutic containing GraminexTM, a compound made of pollen extracts of rye, mais and timothy. To investigate its efficacy, we evalued seminal parameters, inflammatory and oxidative molecules in seminal plasma and clinical and ultrasonographic features of male accessory glands before and after 3 months of treatment in 20 patients taking Deprox HP and 20 patients undergoing treatment with palmitoilethanolammide, bromelin and horse chestnut extract.",[28,449],"Prostatitis","2025-08-13",{"date":452,"type":37},"2025-08-14",{"date":454,"type":21},"2025-09-01",{"date":456,"type":21},"2026-05-01",{"name":458,"class":44},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":16,"minAge":466,"maxAge":132,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":485,"locationsCount":45},"100589582","the-efficiency-of-a-new-sperm-wash-device-for-intrauterine-insemination-in-couples-with-infertility-100589582","NCT06956287","The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility","IUI","Inclusion Criteria:\n\n* Males aged between 25 to 50 years.\n* Part of a couple diagnosed with infertility.\n* Undergoing intrauterine insemination (IUI) treatment.\n* Sperm concentration \\>15 million\u002FmL, progressive motility \\>32%, and total motile sperm count \\>40 million after wash.\n* Willingness of both partners to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Known female infertility factors requiring assisted reproductive technologies beyond IUI.\n* Severe male factor infertility (e.g., oligoasthenoteratozoospermia).\n* Use of donor sperm or oocyte.\n* Chronic illness or medications affecting sperm quality.\n* Prior participation in another clinical trial within the past 3 months.","25 Years",{"count":468,"type":21},120,[24],"This study evaluates the effectiveness of a novel sperm-wash device designed to improve outcomes in intrauterine insemination (IUI) for couples with infertility. Traditional sperm preparation methods, such as density gradient centrifugation (DGC), are associated with elevated reactive oxygen species (ROS) levels and increased sperm DNA fragmentation, potentially compromising pregnancy rates. The new device aims to reduce these adverse effects by minimizing oxidative stress and preserving sperm DNA integrity.\n\nIn this prospective, randomized controlled trial, 120 couples will be allocated to either the intervention group using the new device or the control group using DGC. The primary outcome is the clinical pregnancy rate, while secondary outcomes include sperm DNA fragmentation. The study hypothesizes that the novel device will result in higher pregnancy rates and reduced DNA fragmentation compared to DGC. These findings may support its use as a more physiological approach to sperm preparation in fertility treatment.",[472,28],"Infertility",[472,474,475,476,477,244,478,387],"intrauterine insemination (IUI)","artificial insemination husband","sperm selection","sperm DNA fragmentation","fertility treatment","2025-05-05",{"date":481,"type":37},"2025-05-08",{"date":483,"type":37},"2025-04-24",{"date":187,"type":21},{"name":486,"class":44},"Chung Shan Medical University",{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":498,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":45},"100540993","study-to-verify-the-efficacy-of-a-product-containing-125-mg-of-tetrasod-for-the-treatment-of-male-infertility-100540993","NCT06324071","Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility","A Double-blind Randomized Placebo-controlled Clinical Study to Verify the Efficacy of TetraSOD® in the Improvement of Semen Quality in Patients With iIdiopathic Infertility","Inclusion Criteria:\n\n* Age: 18 to 45\n* Male patients with idiopathic infertility classified with asthenozoospermia, oligozoospermia or oligoasthenozoospermia after seminal assessment.\n* Not achieving pregnancy after at least one year of intercourse with the same partner without protective measures\n\nExclusion Criteria:\n\n* Azoospermia (absence of spermatozoa) or severe oligozoospermia (\\\u003C 5 x 10\\^6 spermatozoa\u002Fml of ejaculate)\n* Testicular torsion or prostatitis\n* Urinary retention and infections\n* Drug consumption\n* Hormone treatments\n* Recent surgical interventions\n* Diabetes\n* Kidney or liver disease\n* Leukocytosis\n* Antioxidant supplement consumption in the last 3 months\n* BMI\\>30 Kg\u002Fm2\n* Endocrinopathies, hypo and hyperthyroidism\n* Chromosomal anomalies (XX, XYY, XXY)\n* Treatments with anticoagulants\n* Radiotherapy\u002FChemotherapy\n* Participation in another clinical study prior to inclusion in this study that could affect the objectives of the current study",{"count":445,"type":21},[24],"TetraSOD® is a unique marine phytoplankton (Tetraselmis chuii) SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino, S.L. (Spain). In a previous pilot trial, the ability of TetraSOD® (dose: 250 mg\u002Fday) to improve semen characteristics in idiopathic infertile men after three months of treatment was assessed, revealing significant improvements in almost all of the analyzed parameters. In a further clinical trial close to finish (ClinicalTrials.gov Identifier: NCT04864314) using the same dose, such positive results have been tested again in a higher number of patients, and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality. In this new clinical trial, an intermediate dose (125 mg\u002Fday) is going to be tested in an attempt to determine a range of TetraSOD® dosage being clinically active for the treatment of male infertility.",[28],[499,500,501],"TetraSOD®","Idiopathic Male Infertility","Oxidative stress","2025-03-06",{"date":504,"type":37},"2025-03-10",{"date":506,"type":37},"2024-01-08",{"date":508,"type":21},"2025-12",{"name":510,"class":434},"Fitoplancton Marino, S.L.",{"id":512,"slug":513,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":163,"sex":16,"minAge":466,"maxAge":132,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":523,"conditions":524,"keywords":525,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":545,"locationsCount":45},"100523157","phase-2-supplementation-for-male-subfertility-100523157","NCT06091969","Supplementation for Male Subfertility","Nutraceutical Supplementation for Male Subfertility","FertEnhancer","Inclusion Criteria:\n\n* Males between the ages of 25-50 years diagnosed with subfertility through Ontario Networks of Experts in Fertility (ONE Fertility, Burlington, ON).\n* For diagnosis of male subfertility, the 2010 and 2021 World Health Organization criteria will be used for sperm count, motility, morphology and vitality.\n* Overweight and obese males according to body mass index (BMI) between the ages of 25-50 years.\n\nExclusion Criteria:\n\n* Smoking,\n* history and drug alcohol abuse,\n* BMI \\> 30 kg\u002Fm2,\n* genital disease (cryptorchidism, current genital inflammation, or varicocele),\n* genital trauma or surgery to the male reproductive system,\n* known Y chromosome microdeletions or karyotype abnormalities (if known prior),\n* hepatobiliary disease,\n* significant renal insufficiency,\n* occupational exposures to reproductive toxins,\n* endocrine abnormality,\n* recent or current sexually transmitted infection,\n* use of cytotoxic drugs,\n* use of immunosuppressants,\n* use of anticonvulsants,\n* use of androgens or antiandrogens,\n* history of central nervous system injury,\n* neurological or psychiatric disease to potentially compromise study data collection,\n* treatment of erectile dysfunction with any drugs during the past 4 weeks,\n* history of cancer chemotherapy,\n* current supplementation with ingredients being tested unless 1-month washout period",{"count":520,"type":21},64,[522],"PHASE2","Old age, obesity, physical inactivity, environmental factors and genetics may contribute negatively to fertility in both males and females. In males, specifically, certain supplements, such as single antioxidants and trace minerals, have previously been shown to improve sperm function marginally. One hypothesis is that sperm function can be improved even further by combining several different types of supplements (e.g., amino acids, energy carriers, vitamins, antioxidants, and trace minerals) to target several age-related cell pathways, for example, oxidative stress, mitochondrial dysfunction, inflammation and cell energetics. This 3-month placebo-controlled, randomized clinical trial, aims to test the effects of a novel multi-ingredient supplement (Fertility Enhancer) that targets several age-related cell pathways on sperm function in overweight or obese and subfertile males.",[28],[526,472,527,528,529,530,531,532,501,391,533,534,535,536,537,538],"Sub-fertility","Antioxidants","Supplements","Creatine","Arginine","Vitamins","Aging","DNA","Mitochondria","Fragmentation","ATP","Weight loss","Obesity","2024-10-08",{"date":541,"type":37},"2024-10-10",{"date":543,"type":21},"2025-01-01",{"date":294,"type":21},{"name":546,"class":44},"Hamilton Health Sciences Corporation",{"id":548,"slug":549,"hasResults":11,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":163,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":556,"conditions":557,"keywords":560,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":45},"100530981","protocol-n-2014---observational-study-on-the-quality-of-life-of-outpatients-100530981","NCT06193850","Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients","Observational Study on the Quality of Life of Patients Attending General Urology, Sexual Medicine, Reproductive Medicine, Uro-oncology, Neuro-urology, Functional Urology Clinics","Inclusion Criteria:\n\n* subjects belonging to general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.\n* subjects \\>= 18 years old\n* signature of informed consent\n\nExclusion Criteria:\n\n* \\- subjects \\\u003C 18 years\n* presence of mental or physical disability that may prevent the patient from answering the questionnaires.",{"count":555,"type":21},10000,"Prospective observational study on the quality of life of patients attending general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.The data relating to the clinical conditions (disease state, psychological and related to quality of life) of the patients belonging to the above-mentioned clinics will be collected in a specially designed database which will allow us to extract the data in a simple and safe way used for statistical analyses. in clinical research.",[558,28,559],"Urologic Diseases","Sexual Medicine",[28,561,562],"urology","rare male cancer","2024-01-04",{"date":565,"type":37},"2024-01-05",{"date":567,"type":37},"2015-02-24",{"date":569,"type":21},"2045-01-31",{"name":571,"class":44},"IRCCS San Raffaele",{"id":573,"slug":574,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":594,"locationsCount":45},"100416551","relationship-of-the-microenvironment-and-male-fertility-100416551","NCT04704141","Relationship of the Microenvironment and Male Fertility","Relationship of the Gut and Genitourinary Tract Microenvironment and Male Fertility","Inclusion Criteria:\n\n* Men diagnosed with infertility who consent to participate in the study\n\nExclusion Criteria:\n\n* Prior hormone replacement therapy\n* Antibiotic use in past 6 months\n* Inability to consent for self, due to age or mental capacity\n* Infertility attributable to identifiable causes other than hypogonadism",{"count":580,"type":21},150,"Although much is known about the microenvironment of the gut and the vagina, very little has been published on the microenvironment of the seminal plasma. The seminal plasma is the support fluid for sperm, providing nutrients, facilitating sperm transit to the uterus, and promoting fertilization. It is a rich area of research for markers of fertility and treatment targets.\n\nThe investigators hypothesize that (1) there are significant populations of seminal microorganisms associated with seminal leukocyte counts well below the WHO's cutoff for pyospermia (1 million\u002FmL) that were not previously detected by traditional culturing methods, and (2) there are pathologic populations of bacteria within the gut and semen microbiome which negatively impact overall fertility, by directly or indirectly impairing hormone status.\n\nParticipants will be recruited from the Male Fertility practice at the University of Illinois-Chicago (UIC). All participants will have infertility, diagnosed as an inability to conceive pregnancy after 12 months of unprotected intercourse. The normal evaluation of these participants is to obtain at least one semen analysis and bloodwork investigating their endocrine profile: total testosterone, estradiol, sex hormone binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and albumin. Semen volume is typically \\>1 mL, and \\\u003C0.2 mL is typically used for the semen analysis. If over 1 million\u002FmL round cells are identified, then a Papanicolaou stain would be performed to identify leukocytes. In this study, any semen demonstrated to have round cells would undergo Papanicolaou staining. A portion of the remaining semen, which would typically be discarded, will be sent for microbiome analysis.\n\nSecondly, as part of routine care, fertility patients may be started on medications to increase endogenous testosterone (i.e.: clomiphene citrate, anastrozole, etc). Participants started on medications will also be asked to submit a rectal swab for gut microbiome analysis. Routine care is to monitor the hormonal and testicular response with periodic endocrine blood panels and semen analyses; rectal swabs will be requested at these follow-up intervals also. The control group for both hypotheses will be men with clinical infertility with normal semen analyses and hormone profiles.",[28,583],"Male Hypogonadism",[472,585,586,587],"Microenvironment","Microbiome","Seminal Fluid","2023-04-17",{"date":590,"type":37},"2023-04-20",{"date":592,"type":21},"2023-06",{"date":274,"type":21},{"name":595,"class":44},"University of Illinois at Chicago"]