[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659552":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":23,"studyPopulation":24,"armGroups":25,"interventions":20,"overallOfficials":20,"centralContacts":38,"locations":44,"responsibleParty":63,"collaborators":20,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":20,"enrollmentInfo":77,"targetDuration":20,"studyType":80,"phases":20,"briefSummary":81,"conditions":82,"keywords":20,"overallStatus":47,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Men sexual health","Differences in the Sexual Satisfaction Index (ISS) score between infertile men undergoing homologous vs. heterologous fertilization","Day 1",[14,17],{"measure":15,"description":16,"timeFrame":12},"Women sexual health","Differences in the Sexual Satisfaction Index (ISS) score between infertile women undergoing homologous vs. heterologous fertilization",{"measure":18,"description":19,"timeFrame":12},"Couples sexual health","Differences in the Sexual Satisfaction Index (ISS) score between subjects (both male and female) undergoing homologous or heterologous fertilization VS control of fertile couples",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":6,"maskingInfo":20},"COHORT","The aim of the study is to evaluate the impact of infertility on sexual function. The following validated questionnaires will be administered to both the study couples and the control group:\n\n* All couples: Index of Sexual Satisfaction (ISS; 25 items; approximately 5 minutes to complete) and the Depression Anxiety Stress Scale-21 (DASS-21; 21 items; approximately 4 minutes to complete).\n* Infertile couples only: Fertility Problem Inventory (FPI; 46 items; approximately 10 minutes to complete).\n* All male participants: International Index of Erectile Function (IIEF; 15 items; approximately 4 minutes to complete).\n* All female participants: Female Sexual Function Index (FSFI; 19 items; approximately 4 minutes to complete).\n\nQuestionnaire data will be collected from infertile couples undergoing homologous or heterologous assisted reproductive treatment. The control group will consist of couples attending the same outpatient clinic who have previously achieved at least one full-term pregnancy without the use of assisted reproductive technology (ART).","Fertile and infertile couples attending the Urology Department and the MAR service",[26,29,32,35],{"label":27,"type":20,"description":28,"interventionNames":20},"group 1","infertile men",{"label":30,"type":20,"description":31,"interventionNames":20},"group 2 control","fertile men",{"label":33,"type":20,"description":34,"interventionNames":20},"group 3","infertile women",{"label":36,"type":20,"description":37,"interventionNames":20},"group 4 control","fertile women",[39],{"name":40,"role":41,"phone":42,"phoneExt":20,"email":43},"Luca Boeri, MD, PhD","CONTACT","+390255034501","LUCA.BOERI@POLICLINICO.MI.IT",[45],{"facility":46,"status":47,"city":48,"state":20,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","RECRUITING","Mirano","20122","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],12.10775,45.49458,{"lat":56,"lon":55},[59,60],{"name":40,"role":41,"phone":42,"phoneExt":20,"email":43},{"name":61,"role":62,"phone":20,"phoneExt":20,"email":20},"Edgardo Somigliana, Prof., MD","SUB_INVESTIGATOR",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Luca Boeri","Principal Investigator","100659552","impact-of-infertility-on-the-sexual-sphere-in-couples-undergoing-assisted-reproduction-100659552",false,"NCT07864935","Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction","A Retrospective and Prospective Study on the Impact of Infertility on the Sexual Sphere in Couples Undergoing Homologous and Heterologous Assisted Reproduction and in Fertile Controls","LIFE","Inclusion Criteria:\n\n* Sexually active (at least 2 intercourses\u002Fweek)\n* Patients who have signed the informed consent form\n\nExclusion Criteria:\n\n* Conditions that may affect the sexual function (induratio penis plastica, hypogonadism, genital lichen planus, dyspareunia)\n* Psychiatric\u002Fdepressive conditions","ALL","18 Years",{"count":78,"type":79},240,"ESTIMATED","OBSERVATIONAL","Fertile and infertile couples attending the Urology Unit and the Assisted Reproductive Technology (ART) Service at our Foundation will be enrolled. As part of the standard of care, all couples will undergo both a gynecological evaluation and consultation and an andrological evaluation and consultation.\n\nIn accordance with routine clinical practice, infertile couples will be asked during the consultation to complete validated self-administered questionnaires designed to assess the impact of infertility on their sexual function.",[83,84,85],"Sexual Health Quality of Life","Infertile Patients","Assisted Reproduction","2026-10-02",{"date":88,"type":89},"2026-10-08","ACTUAL",{"date":91,"type":89},"2026-08-01",{"date":93,"type":79},"2028-01-30",{"name":5,"class":6},1]