[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482835":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":28,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1",null,"SLE patients receiving CYC alone",{"label":13,"type":10,"description":14,"interventionNames":10},"Group 2","SLE patients receiving both CYC and leuprolide acetate (GnRH-a)",{"label":16,"type":10,"description":17,"interventionNames":10},"Group 3","Control subjects, Age-matched female SLE patients without a history of reproductive disorders",[19],{"name":20,"affiliation":21,"role":22},"Sarfaraz A Hasni, M.D.","National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","PRINCIPAL_INVESTIGATOR",[24],{"name":20,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","(301) 451-1599","hasnisa@mail.nih.gov",[29],{"facility":21,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-77.10026,38.98067,{"lat":40,"lon":39},[43],{"name":44,"role":25,"phone":45,"phoneExt":10,"email":27},"Sarfaraz Hasni, M.D.","301-451-1599",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100482835","gonadotropin-releasing-hormone-agonist-gnrha-in-ovarian-preservation-in-sle-subjects-receiving-cyclophosphamide-as-determined-by-questionnaires-100482835",false,"NCT05567198","Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires","Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires","* ELIGIBILITY CRITERIA:\n* INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone\n\nSLE females \\\u003C40 years at the beginning of CYC treatment without GnRH-a cotreatment.\n\n-EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone\n\nFemales \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs).\n\n-INCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg\u002Fmonth or 11.25mg\u002Fevery 3 months.\n\nSLE females \\\u003C40 years at the beginning of CYC treatment with GnRH-a cotreatment.\n\n-EXCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg\u002Fmonth or 11.25mg\u002Fevery 3 months.\n\nFemales \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated STIs.\n\n-Group: Control subjects.\n\nAge-matched female SLE patients without a history of reproductive disorders, infertility, or untreated STIs, who have not received CYC either with or without GnRH-a.","FEMALE","18 Years","120 Years",{"count":59,"type":60},100,"ESTIMATED","OBSERVATIONAL","Background:\n\nSystemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not.\n\nObjective:\n\nTo find out whether GnRHa can help protect women s ovaries during CYC.\n\nEligibility:\n\nWomen under age 40 years starting CYC treatment with or without GnRHa.\n\nDesign:\n\nThis study will do 2 things: It will conduct patient surveys. It will collect data from medical records.\n\nParticipants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked about their history of pregnancy or infertility.\n\nParticipants can take the survey in 4 ways:\n\nOn paper, sent through the mail.\n\nOnline, in a secure web page managed by the NIH.\n\nBy phone.\n\nIn person, during a routine visit to the NIH clinic.\n\nThe survey will take about 30 minutes.\n\nParticipants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments.\n\nResearchers will also collect data about participants reproductive history. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections.",[64,65],"Systemic Lupus Erythematosus (Sle)","Primary Ovarian Insufficiency (Poi)",[65,67,68,69,70],"Nephritis","Neuro-Psychiatric Lupus","Anti-Mullerian Hormone (Amh)","Natural History","2026-06-17",{"date":73,"type":74},"2026-06-18","ACTUAL",{"date":76,"type":74},"2023-03-03",{"date":78,"type":60},"2027-05-31",{"name":21,"class":6},1]