[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-ovarian-insufficiency-poi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-ovarian-insufficiency-poi":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,76,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":20,"type":21},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.",[25,26],"Systemic Lupus Erythematosus (Sle)","Primary Ovarian Insufficiency (Poi)",[26,28,29,30,31],"Nephritis","Neuro-Psychiatric Lupus","Anti-Mullerian Hormone (Amh)","Natural History","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":36},"2023-03-03",{"date":40,"type":21},"2027-05-31",{"name":42,"class":43},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100635377","phase-1-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-the-treatment-of-primary-ovarian-insufficiency-100635377","NCT07551895","Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Primary Ovarian Insufficiency","A Phase I\u002FⅡ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Primary Ovarian Insufficiency","HS_SW01","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form;\n2. Age ≥18 to \\\u003C40 years, with oligomenorrhea or amenorrhea \\>4 months;\n3. Serum baseline FSH \\>25 U\u002FL (at least two measurements, interval \\>4 weeks);\n4. Have received stable standard treatment for POI, such as ≥3 months of standardized hormone replacement therapy (HRT) with stable hormone levels;\n5. No fertility requirement and adherence to strict contraception.\n\nExclusion Criteria:\n\n1. Individuals with childbearing plans or those who are pregnant.\n2. Genetic disorders, chromosomal abnormalities, or genetic defects known to cause premature ovarian insufficiency (POI).\n3. Endocrine disorders affecting ovarian function, including polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, diabetes mellitus, and abnormalities of thyroid or adrenal function.\n4. Presence of breast, uterine, or ovarian tumors; known or suspected sex hormone-dependent malignancies; or any other benign or malignant tumors.\n5. Primary amenorrhea.\n6. Uterine malformations.\n7. Iatrogenic or drug-induced ovarian insufficiency.\n8. Uncontrolled acute or chronic gynecological inflammation (including endometritis, etc.).\n9. Bilateral endometrial thickness ≤8 mm after moderate-to-severe intrauterine adhesion surgery.\n10. Complicated with endometriosis.\n11. Severe functional impairment of major organs or coagulation disorders.\n12. Active venous or arterial thromboembolic disease within the past 6 months.\n13. Severe hepatic or renal insufficiency, etc.\n14. Vaccination with live or live-attenuated vaccines within 2 months prior to enrollment.\n15. Prior treatment with mesenchymal stem cells less than 3 months before enrollment.\n16. Uncontrolled hypertension (\\>150\u002F100 mmHg).\n17. Any of the following conditions within 3 months prior to enrollment:\n\n    1. Major trauma or major surgery (including joint surgery), or anticipated need for major surgery during the study period, which in the investigator's opinion poses unacceptable risk to the participant;\n    2. Receipt of plasma exchange or extracorporeal photopheresis;\n    3. Participation in any other interventional clinical trial.","40 Years",{"count":55,"type":21},21,"INTERVENTIONAL",[58,59],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of human umbilical cord mesenchymal stem cell injection (HS\\_SW01 cells injection) in patients with Primary Ovarian Insufficiency (POI).\n\nParticipants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.",[26],[63,64],"Primary Ovarian Insufficiency","MSC","NOT_YET_RECRUITING","2026-04-22",{"date":68,"type":36},"2026-04-27",{"date":70,"type":21},"2026-04-15",{"date":72,"type":21},"2027-12-31",{"name":74,"class":75},"Shenzhen Huishan Biotechnology Co., Ltd.","INDUSTRY",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":56,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":44},"100580230","phase-4-bleeding-patterns-in-sequential-and-continuous-progesterone-supplementation-in-adolescents-with-turner-syndrome-100580230","NCT06834594","Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome","Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)","BOOST","Inclusion Criteria:\n\n* Diagnosis of Turner Syndrome and Primary Ovarian Insufficiency.\n* Prescribed adult dosing\\* of transdermal or oral estradiol for estrogen replacement therapy.\n\n  \\*Adult dosing of will be defined per published clinical practice guidelines from the 2023 International Turner Syndrome Meeting (i.e. 50-200μg\u002Fday of transdermal estradiol, or (i.e. 50-200μg\u002Fday of transdermal estradiol or 2-4mg\u002Fday oral estradiol).\n* Have achieved menarche.\n\nExclusion Criteria:\n\n* Disclosure of sexual activity and desire for contraception.\n* Having a levonorgestrel-releasing intrauterine device or etonogestrel arm implant in place.\n* Having received depot medroxyprogesterone within one year prior to study recruitment.\n* Non-English or non-Spanish speaking.","12 Years","20 Years",{"count":87,"type":21},40,[89],"PHASE4","This is a single-site open label non-randomized study comparing effects of sequential versus continuous use of progesterone supplementation amongst Turner Syndrome (TS) patients with primary ovarian insufficiency (POI) prescribed hormone replacement therapy (HRT).",[92,26],"Turner Syndrome",[94,95,96],"Turner syndrome","Primary ovarian insufficiency","Hormone replacement therapy","2025-08-27",{"date":99,"type":36},"2025-09-04",{"date":101,"type":36},"2025-07-31",{"date":103,"type":21},"2026-07-31",{"name":105,"class":106},"Children's Mercy Hospital Kansas City","OTHER",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":115,"targetDuration":4,"studyType":56,"phases":117,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100601990","safety-and-efficacy-of-autologous-adipose-derived-regenerative-cells-adrcs-injection-for-improving-diminished-ovarian-reserve-100601990","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.",{"count":116,"type":21},25,[118],"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.",[121,26,122],"Diminished Ovarian Reserve (DOR)","Ovarian Failure, Premature",[124,125,126,127,128],"Diminished Ovarian Reserve","Adipose-Derived Regenerative Cells","anti-Müllerian hormone","follicle-stimulating hormone","antral follicle count","2025-08-05",{"date":131,"type":36},"2025-08-12",{"date":133,"type":21},"2025-08-25",{"date":135,"type":21},"2027-08-01",{"name":137,"class":75},"Cytori Therapeutics"]