[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601990":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":22,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":32,"eligibilityCriteria":33,"healthyVolunteers":28,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":48,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"Cytori Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ADRCs group","EXPERIMENTAL",null,[13],"Device: Autologous Adipose-Derived Regenerative Cells (ADRCs) Intraovarian Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Autologous Adipose-Derived Regenerative Cells (ADRCs) Intraovarian Injection","Under general anesthesia, patients undergo lower abdominal liposuction (aspirate: 100-360 mL). ADRCs are immediately prepared bedside using the Celution® system (Cytori Therapeutics): Lipoaspirate is processed in a sterile container with automated separation, centrifugation, and resuspension (90-120 min). From the 5mL ADRCs suspension obtained, 0.5mL is reserved for QC (cell count\u002Fviability\u002Fsurface markers); 4.5mL is injected bilaterally into ovarian stroma (2-2.5mL\u002Fovary). Post-procedure, patients are monitored supine for 30 min for local\u002Fsystemic reactions before discharge if stable.",[9],{"type":21,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[23],{"name":24,"class":25},"Peking University People's Hospital","OTHER","100601990","safety-and-efficacy-of-autologous-adipose-derived-regenerative-cells-adrcs-injection-for-improving-diminished-ovarian-reserve-100601990",false,"NCT07117682","Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) Injection for Improving Diminished Ovarian Reserve","Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) Injection for Improving Diminished Ovarian Reserve (ARISE) - A Single-arm Self-controlled Study","ARISE-01","Inclusion Criteria:\n\n1. Female patients aged 20-39 years.\n2. Diagnosed with DOR, defined as AFC \\\u003C 7 and\u002For AMH ≤ 1.1 ng\u002FmL.\n3. FSH ≤ 40 U\u002FL.\n4. Have signed informed consent for the clinical trial.\n5. In good general health and able to tolerate local anesthesia, liposuction, oocyte retrieval, as well as pregnancy and childbirth.\n6. Without relative contraindications to fertility such as hereditary tumor-related diseases.\n\nExclusion Criteria:\n\n1. Presence of thyroid disorders.\n2. Body Mass Index (BMI) \\\u003C 18 kg\u002Fm².\n3. Confirmed pregnancy (positive β-hCG with ultrasound confirmation of embryo implantation).\n4. History of autoimmune diseases.\n5. Family history of ovarian tumors.\n6. Prior pelvic or systemic radiotherapy for cancer treatment.\n7. Positive serology\u002Fvirology results for human immunodeficiency virus (HIV), Hepatitis C, Hepatitis B, Syphilis, human papillomavirus (HPV), or abnormal ThinPrep cytology (TCT).\n8. DOR caused by genetic disorders.\n9. Reproductive system pathologies including polycystic ovary syndrome (PCOS), adenomyosis, uterine fibroids ≥ 5 cm, endometrial carcinoma, or uterine malformations.\n10. Contraindications to liposuction.\n11. Abnormal semen analysis of the male partner precluding natural conception or conception via assisted reproductive technology (ART).\n12. Malignancy-related conditions such as active malignancy without complete remission or chemotherapy administration within the past 6 months.","FEMALE","18 Years","40 Years",{"count":38,"type":39},25,"ESTIMATED","INTERVENTIONAL",[42],"NA","Diminished Ovarian Reserve (DOR) poses significant challenges to fertility and hormonal health, with limited effective treatments. This prospective, self-controlled clinical study evaluates the safety and efficacy of intraovarian injection of autologous Adipose-Derived Regenerative Cells (ADRCs) to improve ovarian function in reproductive-aged women with DOR.\n\nThe ARISE trail enrolled 25 women aged \\\u003C40 years meeting clinical criteria for DOR, excluding those with severe comorbidities. Autologous adipose tissue was harvested via liposuction, and ADRCs were isolated using the Celution® system before bilateral ovarian medulla injection. Participants underwent follow-up at multiple time points up to 12 months post-procedure.\n\nPrimary outcomes included cumulative clinical pregnancy rates (natural or via ART) within 12 months and 1-, 2-, 3-, 6-month changes in ovarian reserve markers (FSH, AMH, antral follicle count) in non-pregnant patients. Secondary outcomes encompassed ovarian reserve markers at 12 months, as well as menstrual pattern recovery and ovarian volume changes at 1, 2, 3, 6, 12 months. Adverse events (AEs) will be monitored at each time point.\n\nStatistical analyses followed standard principles, including mixed models for repeated measures and appropriate tests for subgroup comparisons. Sample size was determined based on feasibility and prior effect size estimates to ensure adequate power.\n\nThis study provides novel insights into regenerative therapies for DOR, emphasizing safety and functional restoration.",[45,46,47],"Diminished Ovarian Reserve (DOR)","Primary Ovarian Insufficiency (Poi)","Ovarian Failure, Premature",[49,50,51,52,53],"Diminished Ovarian Reserve","Adipose-Derived Regenerative Cells","anti-Müllerian hormone","follicle-stimulating hormone","antral follicle count","NOT_YET_RECRUITING","2025-08-05",{"date":57,"type":58},"2025-08-12","ACTUAL",{"date":60,"type":39},"2025-08-25",{"date":62,"type":39},"2027-08-01",{"name":5,"class":6}]