[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558104":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":47,"overallOfficials":53,"centralContacts":57,"locations":64,"responsibleParty":84,"collaborators":28,"id":86,"slug":28,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":28,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":28,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":67,"whyStopped":28,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Kaohsiung Veterans General Hospital.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":28},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Live birth rate (%)","a viable infant after 24 weeks of gestation","through study completion, an average of 4 year",{"measure":14,"description":15,"timeFrame":12},"oxygen consumption rate of mitochodria (%)","to assess mitocondrial function in cumulus cells",{"measure":17,"description":18,"timeFrame":12},"mRNA levels of cumulus cell genes","to assess cumulus cells gene expression analysis",[20,23,26],{"measure":21,"description":22,"timeFrame":12},"Clinical pregnancy rate (%)","the presence of a fetal heartbeat detected via transvaginal sonography at 6-7 weeks of gestation",{"measure":24,"description":25,"timeFrame":12},"Ongoing pregnancy rate (%)","the continuation of the pregnancy beyond 12 weeks of gestation",{"measure":27,"description":15,"timeFrame":12},"Amount of ATP production (moles\u002Fmin) of mitochodria",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","Aging in female reproductive cells, particularly cumulus granulosa cells, is associated with various dysfunctions that compromise fertility. Melatonin, a hormone primarily produced by the pineal gland, is renowned for its multifaceted roles in regulating physiological processes, including sleep-wake cycles, immune function, and antioxidative defense. Melatonin's antioxidant action is mediated through direct scavenging of free radicals, upregulation of antioxidant enzymes, and improvement of mitochondrial efficiency. These properties make melatonin a promising candidate for mitigating the adverse effects of aging on cellular function. This study aims to explore the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. In the control group, patients will proceed directly to IVF cycles without melatonin supplementation. Cumulus cells will be collected after oocyte retrieval, and gene expression will be measured. Additionally, clinical pregnancy rate, live birth rate, and miscarriage rate between the two groups will be evaluated.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Melatonin group","EXPERIMENTAL","Patients received melatonin supplementation for at least a two-month period prior to IVF cycles",[42],"Dietary Supplement: Melatonin",{"label":44,"type":45,"description":46,"interventionNames":28},"Control group","NO_INTERVENTION","Patients did not receive melatonin supplementation and proceeded directly to IVF cycles",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":28},"DIETARY_SUPPLEMENT","Melatonin","In the study group, patients will receive melatonin supplementation for at least two months prior to IVF cycles",[38],[54],{"name":55,"affiliation":5,"role":56},"Kuan-Hao Tsui","STUDY_DIRECTOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":28,"email":62},"Li-Te Lin","CONTACT","+88673464027","litelin1982@gmail.com",{"name":55,"role":60,"phone":28,"phoneExt":28,"email":28},[65],{"facility":66,"status":67,"city":68,"state":28,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan","RECRUITING","Kaohsiung City","886","Taiwan","TW",{"type":73,"coordinates":74},"Point",[75,76],120.31333,22.61626,{"lat":76,"lon":75},[79,82],{"name":55,"role":60,"phone":80,"phoneExt":28,"email":81},"+886-7-3422121","lllee23@vghks.gov.tw",{"name":59,"role":83,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"type":83,"investigatorFullName":59,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Associate professor","100558104",false,"NCT06546774","The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes","The Effect of Melatonin Supplementation on Cumulus Cells and Reproductive Outcomes in Older Women Undergoing IVF Cycles","Inclusion Criteria:\n\n* Age 35-45 years\n* BMI 18-30 kg\u002Fm2\n* planning to undergo IVF cycles\n\nExclusion Criteria:\n\n* Primary ovarian insufficiency\n* history of oophorectomy\n* receiving oocyte donation\n* Chromosome anomaly\n* Congenital uterine anomaly\n* Severe intrauterine adhesion\n* Malignancy\n* Using hormone therapy or supplements in recent 3 months","FEMALE","35 Years","45 Years",{"count":96,"type":97},200,"ESTIMATED","INTERVENTIONAL",[100],"NA","This study investigates the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. Cumulus cells will be collected after oocyte retrieval, and IVF outcomes will be assessed.",[103],"Unrecognized Condition",[50,105,106,107,108],"Cumulus cells","In vitro fertilization","Old women","Infertility","2024-08-09",{"date":111,"type":112},"2024-08-13","ACTUAL",{"date":114,"type":112},"2021-05-01",{"date":116,"type":97},"2025-12-31",{"name":5,"class":6},1]