[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618380":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":27,"locations":37,"responsibleParty":81,"collaborators":10,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":10,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":10,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":114,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Città di Lecce Hospital, GVM Care & Research","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Long-term Warfarin Group",null,"Male patients undergoing cardiac surgery with an indication for lifelong oral anticoagulation with warfarin, typically after mechanical heart valve replacement. Warfarin therapy is prescribed as part of standard clinical care and is not assigned by the study.",[13],"Other: Semen analysis, sperm DNA fragmentation and hormonal evaluation",{"label":15,"type":10,"description":16,"interventionNames":17},"Short-term Warfarin Group","Male patients undergoing cardiac surgery with an indication for short-term postoperative warfarin therapy (approximately three months), such as after valve repair or bioprosthetic valve implantation. Anticoagulation is administered according to standard clinical practice and not determined by the study protocol.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Control Group (No Long-term Anticoagulation)","Male patients undergoing cardiac surgery without an indication for long-term oral anticoagulation beyond routine perioperative prophylaxis. These patients serve as a comparison group and do not receive chronic warfarin therapy.",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Semen analysis, sperm DNA fragmentation and hormonal evaluation","Participants undergo standardized study assessments including semen analysis according to WHO criteria, sperm DNA fragmentation assessment, hormonal blood tests, andrological ultrasound, and exploratory molecular analyses of spermatozoa (mitochondrial function, oxidative stress markers, inflammatory mediators, and protein expression). All assessments are performed for observational and research purposes only and do not guide or modify clinical treatment.",[19,9,15],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Giuseppe Santarpino, MD, PhD","CONTACT","+393246940566","gsantarpino@gvmnet.it",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},"Veronica D'Anna, MSc","+39 3891437634","veronicadanna21@gmail.com",[38],{"facility":39,"status":10,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Città di Lecce Hospital - Department of Cardiac Surgery","Lecce","LE","73100","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],18.17244,40.35481,{"lat":49,"lon":48},[52,55,57,59,62,64,66,68,70,72,74,76,78,79],{"name":53,"role":30,"phone":54,"phoneExt":10,"email":32},"Giuseppe Santarpino MD, PhD, Cardiac Surgeon","+39 3246940566",{"name":34,"role":30,"phone":56,"phoneExt":10,"email":36},"+393891437634",{"name":29,"role":58,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":10,"phoneExt":10,"email":10},"Angelo M. Dell'Aquila, MD, PhD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":10,"phoneExt":10,"email":10},"Lamberto Coppola, MD, PhD",{"name":65,"role":61,"phone":10,"phoneExt":10,"email":10},"Alessandra Ferramosca, PhD",{"name":67,"role":61,"phone":10,"phoneExt":10,"email":10},"Francesco Murrieri, MSc",{"name":69,"role":61,"phone":10,"phoneExt":10,"email":10},"Alessia Ramundo, MSc",{"name":71,"role":61,"phone":10,"phoneExt":10,"email":10},"Gabor Szabo, MD, PhD",{"name":73,"role":61,"phone":10,"phoneExt":10,"email":10},"Marika Massaro, PhD",{"name":75,"role":61,"phone":10,"phoneExt":10,"email":10},"Stefano Quarta, PhD",{"name":77,"role":61,"phone":10,"phoneExt":10,"email":10},"Alessandro Fiorentino, MSc",{"name":34,"role":61,"phone":10,"phoneExt":10,"email":10},{"name":80,"role":61,"phone":10,"phoneExt":10,"email":10},"Giulia Palisi, MSc",{"type":82,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100618380","warfarin-effects-on-male-fertility-after-cardiac-surgery-100618380",false,"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.","MALE","18 Years","50 Years",{"count":94,"type":95},90,"ESTIMATED","OBSERVATIONAL","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.",[99,100],"Male Infertility","Heart Valve Disease",[102,103,104,105,106,107,108,109,110,111,112,113],"warfarin","male infertility","Semen quality","Sperm DNA fragmentation","Mitochondrial function","Inflammation","Mechanical heart valve","Cardiac surgery","Oral anticoagulation","Vitamin K antagonists","Reproductive hormones","anticoagulation","NOT_YET_RECRUITING","2025-12-29",{"date":117,"type":118},"2026-01-09","ACTUAL",{"date":120,"type":95},"2026-02",{"date":122,"type":95},"2028-06",{"name":5,"class":6},1]