[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polycystic-ovary-syndrome-pcos\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polycystic-ovary-syndrome-pcos":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,48,80,110,132,163,187,214,233,259,290,315,339,362,393,419,441,463,489,514,538,565],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100631349","fertility-and-polycystic-ovary-syndrome-100631349",false,"NCT07499518","Fertility and Polycystic Ovary Syndrome","Description of Fertility and Pregnancies in Patients With Polycystic Ovary Syndrome","FERTIOPK","Inclusion Criteria- PCOS group:\n\n* Aged between 18 and 45 years old\n* Female with a diagnosis of PCOS according to ESHRE criteria\n* Previouslu enrolled in METABOPK research\n\nInclusion Criteria- Control group\n\n* Aged between 18 and 45 years old\n* Female with normal metabolic and hormonal profiles\n* Previouslu enrolled in METABOPK research\n\nExclusion Criteria:\n\n* A prior diagnosis of type 1 or type 2 diabetes\n* A diagnosis of non-classical adrenal block\n* Use of hormonal therapy, oral antidiabetic medication, lipid-lowering medication, antihypertensive medication, corticosteroids, or spironolactone\n* Menopause or current pregnancy\n* Lack of data on BMI, insulin levels, and fasting blood glucose\n* Patients who do not speak French\n* Patients under legal guardianship, conservatorship, or curatorship",true,"FEMALE","18 Years","45 Years",{"count":22,"type":23},473,"ESTIMATED","OBSERVATIONAL","Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among women of reproductive age and affects approximately 10% of women worldwide. The diagnosis is based on the Rotterdam criteria established in 2003 and updated in the latest recommendations from the European Society of Human Reproduction (ESHRE) in 2023. The diagnosis of PCOS is based on the presence of 2 of the following 3 criteria:\n\n1. Oligo-anovulation\n2. Clinical and\u002For biological hyperandrogenism\n3. Polycystic ovary morphology (PCOM) on imaging It is also the leading cause of anovulatory infertility, with a 15-fold increased risk of infertility.\n\nIt is therefore a major cause of anovulatory infertility, but its pathophysiological mechanisms remain complex and multifactorial, involving interactions between genetic, metabolic, hormonal, and environmental factors. Prior to embarking on a fertility treatment plan, it is essential to better understand how these various factors influence ovarian function and reproductive capacity in patients with PCOS. Identifying and characterizing factors associated with fertility-such as hormonal profiles, insulin sensitivity, and metabolic markers-could help better predict future fertility and optimize personalized care and fertility outcomes. The aim of this study is therefore to identify modifiable factors influencing the fertility of PCOS patients phenotyped at La Pitié-Salpêtrière hospital.",[27],"Polycystic Ovary Syndrome (PCOS)",[29,30,31,32,33,34],"PCOS","Fertility","parental project","pregnancy","hormonal factors","metabolic factors","NOT_YET_RECRUITING","2026-06-08",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":23},"2026-06-01",{"date":43,"type":23},"2027-06-01",{"name":45,"class":46},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":47},"100643422","myo-inositol-alone-versus-myo-inositol-plus-alpha-lactalbumin-in-women-with-polycystic-ovary-syndrome-100643422","NCT07629895","Myo-Inositol Alone Versus Myo-Inositol Plus Alpha-Lactalbumin in Women With Polycystic Ovary Syndrome","Comparison of Efficacy of Myo-Inositol Alone With Myo-Inositol Plus Alpha-Lactalbumin on Reproductive and Metabolic Parameters in Polycystic Ovarian Syndrome","MIALA-PCOS","Inclusion Criteria:\n\n* Female participants aged 18 to 35 years.\n* Diagnosed with polycystic ovary syndrome according to Rotterdam criteria.\n* Diagnosis of PCOS for at least 6 months before enrollment.\n* Willing to conceive.\n* Normal husband semen analysis.\n\nExclusion Criteria:\n\n* Pre-existing diabetes mellitus.\n* Thyroid dysfunction.\n* Hyperprolactinemia.\n* Cushing syndrome.\n* Congenital adrenal hyperplasia.\n* Androgen-secreting adrenal or ovarian tumors.\n* Conditions causing ovulatory dysfunction and\u002For hyperandrogenism other than PCOS.\n* Use of ovulation-induction agents, hormonal therapy, insulin sensitizers, or anti-androgens within the previous 12 weeks.\n* Morbid obesity (BMI ≥40 kg\u002Fm²).\n* Known cow milk protein allergy, hypersensitivity to study medications, or severe gastrointestinal malabsorption.\n* Hepatic, renal, or cardiovascular impairment.\n* Tubal factor infertility.\n* Endometriosis.\n* Structural uterine abnormality.\n* Male factor infertility.","35 Years",{"count":58,"type":23},82,"INTERVENTIONAL",[61],"NA","Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting reproductive-aged women and is associated with menstrual irregularities, infertility, hyperandrogenism, obesity, and insulin resistance. Myo-inositol is commonly used as an insulin-sensitizing agent to improve reproductive and metabolic outcomes in women with PCOS. Alpha-lactalbumin may enhance the intestinal absorption and bioavailability of myo-inositol and potentially improve treatment response.\n\nThis randomized controlled trial aims to compare the efficacy of myo-inositol alone versus myo-inositol plus alpha-lactalbumin in women with PCOS. Eighty-two eligible women will be randomized to receive either myo-inositol alone or myo-inositol combined with alpha-lactalbumin for 12 weeks. The study will evaluate reproductive outcomes including spontaneous conception, menstrual regularity, hirsutism, and hormonal parameters, as well as metabolic outcomes including body mass index and insulin resistance.",[27],[29,65,66,67,68,69,70],"Myo-Inositol","Alpha-Lactalbumin","Infertility","HOMA-IR","Reproductive Outcomes","Metabolic Parameters","2026-06-05",{"date":73,"type":39},"2026-06-09",{"date":75,"type":23},"2026-09",{"date":77,"type":23},"2027-06",{"name":79,"class":46},"Quaid-e-Azam Medical College",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100639095","observational-study-on-the-causal-architecture-of-polycystic-ovary-syndrome-pcos-100639095","NCT07623551","Observational Study on the Causal Architecture of Polycystic Ovary Syndrome (PCOS)","An Observational Data Collection Study to Characterize the Hormonal, Metabolic, and Clinical Architecture of Polycystic Ovary Syndrome in Women Aged 18 to 45: A Global Recruitment Initiative","Inclusion Criteria:\n\n* Female\n* Aged 18 to 45 years\n* Diagnosed with Polycystic Ovary Syndrome (PCOS) by a licensed healthcare provider\n* Willing to voluntarily share existing lab results and clinical history\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Over 45 years of age\n* No confirmed PCOS diagnosis from a licensed healthcare provider\n* Unable or unwilling to provide informed consent",{"count":88,"type":23},100,"The goal of this observational study is to learn about the causal architecture of Polycystic Ovary Syndrome (PCOS) in women aged 18 to 45. The main questions it aims to answer are:\n\nWhat does the hormonal, metabolic, and clinical architecture of PCOS look like across a diverse global population? Can the causal architecture of PCOS be reconstructed from existing lab results and clinical data? Are there distinct architectural patterns across different groups of women with PCOS? Participants who have been diagnosed with PCOS by a healthcare provider will complete an online questionnaire about their diagnosis, symptoms, clinical history, current treatment, and existing lab results. Participants will also be asked to submit copies of their most recent blood work and lab results. No intervention or treatment is involved. All data is de-identified.",[91,27,29,92],"Polycystic Ovary Syndrome","PCOS (Polycystic Ovary Syndrome)",[29,91,94,95,96,97,98,99],"Women's Health","Endocrine","Hormonal","Metabolic","Observational Study","Causal Architecture","2026-05-28",{"date":102,"type":39},"2026-06-03",{"date":104,"type":23},"2026-06",{"date":106,"type":23},"2026-07",{"name":108,"class":109},"AnnieGuard Corp.","INDUSTRY",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":18,"minAge":116,"maxAge":20,"enrollmentInfo":117,"targetDuration":118,"studyType":24,"phases":4,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":47},"100636854","construction-of-a-multi-dimensional-risk-assessment-system-a-clinical-study-of-polycystic-ovary-syndrome-complicated-with-thrombophilia-100636854","NCT07571096","Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia","Inclusion Criteria:\n\n* Female participants aged 14 to 45 years\n* Diagnosis of polycystic ovary syndrome (PCOS)\n* For adult participants, PCOS diagnosed according to the 2023 international evidence-based guideline. After exclusion of related disorders, diagnosis is based on ovulatory dysfunction and\u002For irregular menstrual cycles together with clinical hyperandrogenism, biochemical hyperandrogenism, or polycystic ovarian morphology on ultrasound where appropriate\n* For adolescent participants, PCOS diagnosed according to adolescent-specific recommendations. After exclusion of related disorders, both ovulatory dysfunction and\u002For irregular menstrual cycles and clinical or biochemical hyperandrogenism are required\n* Irregular menstrual cycles are defined as follows: more than 1 year and less than 3 years after menarche, menstrual cycles shorter than 21 days or longer than 45 days; more than 3 years after menarche to perimenopause, menstrual cycles shorter than 21 days or longer than 35 days, or fewer than 8 cycles per year; any cycle longer than 90 days more than 1 year after menarche; or primary amenorrhea by age 15 years or more than 3 years after thelarche\n* No use within 3 months before blood sampling of anticoagulant drugs, procoagulant drugs, oral contraceptives, or other medications that may affect sex hormones, insulin, glucose metabolism, or coagulation function\n\nExclusion Criteria:\n\n* Confirmed pregnancy\n* Hematologic disease\n* History of malignant tumor\n* Use of medications within 12 weeks before enrollment that may interfere with study assessments\n* Disorders that may cause hyperandrogenism or ovulatory dysfunction, including congenital adrenal hyperplasia, Cushing syndrome, functional hypothalamic amenorrhea, thyroid disease, hyperprolactinemia, or primary ovarian insufficiency\n* Disorders that may affect protein C or protein S levels, including antiphospholipid syndrome, liver disease, or tumor-related conditions\n* In adolescents, polycystic ovarian morphology alone will not be used to establish the diagnosis of PCOS","14 Years",{"count":88,"type":23},"1 Day","This observational case-control study aims to develop a multidimensional risk assessment model for thrombophilia-related abnormalities in females with polycystic ovary syndrome (PCOS). The study will analyze endocrine, metabolic, and genetic factors associated with decreased protein C and\u002For protein S levels in participants with PCOS. The results are expected to provide evidence for risk stratification and individualized management in this population.",[27,121],"Thrombophilia","RECRUITING","2026-04-30",{"date":125,"type":39},"2026-05-06",{"date":127,"type":39},"2025-03-04",{"date":129,"type":23},"2027-03-17",{"name":131,"class":46},"Guangdong Women and Children Hospital",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":17,"sex":139,"minAge":19,"maxAge":20,"enrollmentInfo":140,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":47},"100630691","polycystic-ovary-syndrome-in-type-1-diabetes-100630691","NCT07490964","Polycystic Ovary Syndrome in Type 1 Diabetes","Pathogenesis of Functional Hyperandrogenism in Women With Type 1 Diabetes Mellitus: From Genetic-molecular Mechanisms to Clinical Phenotype.","1. Non--hyperandrogenic women with type 1 diabetes INCLUSION CRITERIA\n\n   * Premenopausal women between 18 and 45 years old.\n   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.\n   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).\n   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.\n   * Menarche at least three years prior to study entry. EXCLUSION CRITERIA\n   * Honeymoon period of T1D.\n   * Pregnancy or lactation.\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.\n   * Diagnosis of other serious chronic disease.\n   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.\n2. Women with type 1 diabetes and polycystic ovary syndrome INCLUSION CRITERIA\n\n   * Women between 18 and 45 years old.\n   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.\n   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).\n   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.\n   * Menarche at least three years prior to study entry.\n   * PCOS diagnosis based on the 2012 American NIH consensus criteria, including the Rotterdam and AE-PCOS.\n\n   EXCLUSION CRITERIA\n   * Honeymoon period of T1D.\n   * Pregnancy\u002Flactation.\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.\n   * Diagnosis of other serious chronic disease. reatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.\n3. Men with T1D and normal gonadal function of similar age, BMI, and duration of diabetes.\n\n   INCLUSION CRITERIA\n   * Age between 18 and 45 years old.\n   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.\n   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).\n   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.\n\n   EXCLUSION CRITERIA\n   * Honeymoon period of T1D.\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia.\n   * Diagnosis of male hypogonadism.\n4. Women with PCOS of similar age and BMI. INCLUSION CRITERIA\n\n   * Women between 18 and 45 years old.\n   * Menarche at least three years prior to study entry.\n   * PCOS diagnosis based on the 2012 American NIH consensus criteria, including the Rotterdam and AE-PCOS.\n\n   EXCLUSION CRITERIA\n   * Pregnancy\u002Flactation.\n   * Previously known carbohydrate metabolism abnormalities (prediabetes or type 2 diabetes).\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.\n   * Diagnosis of other serious chronic disease.\n   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.\n5. Non-hyperandrogenic control women with regular menses of similar age and BMI. INCLUSION CRITERIA\n\n   * Women between 18 and 45 years old.\n   * Menarche at least three years prior to study entry.\n   * Presence of regular menses.\n   * Lack of signs or symptoms of functional hyperandrogenism. EXCLUSION CRITERIA\n   * Pregnancy\u002Flactation.\n   * Previously known carbohydrate metabolism disturbances.\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.\n   * Diagnosis of other serious chronic disease.\n   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.","ALL",{"count":141,"type":23},60,"BACKGROUND Functional ovarian hyperandrogenism, including the polycystic ovary syndrome (PCOS), is very prevalent in women with type 1 diabetes (T1D). The pathogenic mechanisms of this association remain unclear.\n\nHYPOTHESIS Individual factors expose or protect women with T1D to\u002Ffrom the development of androgen excess and PCOS. Such androgen excess in women with T1D may increase their cardiometabolic risk.\n\nMAIN OBJECTIVE Unveiling the pathogenic mechanisms behind functional hyperandrogenism in women with T1D from a sex\u002Fgender-medicine and sexual dimorphism perspective.\n\nMATERIAL AND METHOS We have designed a cross-sectional comparative clinical study, including 5 groups of study subjects with 12 participans per group:\n\ni) Women with T1D \\& PCOS. ii) Women with T1D without PCOS. iii) Men with T1D and normal gonadal function. iv) Women with PCOS without diabetes mellitus v) Non-hyperandrogenic control women without T1D. All groups will show similar age and body mass index. T1D groups will be matched for duration of disease.\n\nOUTCOMES 1.1 Insulin sensitivity (hyperinsulinaemic euglycaemic clamping). 1.2 Body composition (dual-energy x-ray absorptiometry, bioelectrical impedance analysis \\& sonographic studies).\n\n1.3 Ovarian and adrenal steroidogenesis. 2.1 Differential pattern in genetic variants related with insulin signalling and response, inflammation, adiposity, gonadal function, steroidogenesis, and PCOS itself by whole exome sequencing.\n\n2.2 Microbiopsy studies in deep subcutaneous adipose tissue and skeletal muscle tissue: 2.2.1 Differential DNA methylation patterns in genes associated with PCOS. 2.2.2 Differential transcriptomic pattern in genes associated with PCOS.\n\n2.2.3 Differential proteomic patterns in adipose and muscle tissues. 3. Interaction between T1D and PCOS on parameters of metabolic control (intersticial blood glucose monitoring) and morbidities associated with T1D itself.",[144,27],"Type 1 Diabetes Mellitus",[146,147,148,149,150,151,152,153],"Hyperandrogenism","Type 1 diabetes","Pathogenesis","Steroidogenesis","Insulin resistance","Body composition","Genetics","Epigenetics","2026-04-18",{"date":156,"type":39},"2026-04-22",{"date":158,"type":23},"2026-04-01",{"date":160,"type":23},"2028-12-31",{"name":162,"class":46},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":59,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":47},"100623276","comparison-of-ivf-outcomes-between-ppos-and-antagonist-protocols-in-women-with-pcos-100623276","NCT07394530","Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS","A Comparative Study of In Vitro Fertilization Outcomes Between PPOS and Antagonist Protocols in Women With Polycystic Ovary Syndrome","PPOS-PCOS-IVF","Inclusion Criteria:\n\n* Women aged 18-40 years\n* Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo\u002Fanovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)\n* Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)\n* Eligible for controlled ovarian stimulation for IVF\n* Husband\u002Fpartner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT)\n* Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology.\n* History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)\n* History of recurrent pregnancy loss (≥3 spontaneous miscarriages)\n* Known chromosomal abnormalities in either partner\n* Inability to adhere to study protocol or follow-up procedures","40 Years",{"count":173,"type":23},400,[61],"This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.",[27,177],"Female Infertility","2026-02-09",{"date":180,"type":39},"2026-02-11",{"date":182,"type":39},"2026-01-20",{"date":184,"type":23},"2028-06-30",{"name":186,"class":46},"Hanoi General Hospital (Vietnam)",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":195,"targetDuration":4,"studyType":59,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":47},"100623420","scube-proteins-in-polycystic-ovary-syndrome-ipsos-100623420","NCT07396402","SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)","Study of Scube-1 and Scube-3 in Polycystic Ovary Syndrome (PCOS) and Their Possible Use as Inflammatory Markers and as a Link Between PCOS and Cardiovascular Events.","IPSOS","Inclusion Criteria:\n\n* Female subjects aged 18-35 years\n* Diagnosis of polycystic ovary syndrome (normoinsulinemic or hyperinsulinemic)\n* Availability of basal hormonal evaluation and oral glucose tolerance test\n* Healthy women for control group\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* History of cardiovascular disease\n* Diabetes mellitus or impaired glucose tolerance\n* Hypertension\n* Significant hepatic or renal disease\n* Other endocrine disorders\n* Neoplastic diseases\n* Psychiatric disorders\n* Autoimmune diseases\n* Shift work\n* Obesity\n* Refusal to sign informed consent",{"count":196,"type":23},56,[61],"This study investigates circulating levels of SCUBE-1 and SCUBE-3 proteins in women with polycystic ovary syndrome (PCOS) compared with healthy controls. Differences between normoinsulinemic and hyperinsulinemic PCOS subgroups will be evaluated, as well as correlations with clinical and metabolic parameters related to inflammation and cardiovascular risk.",[27,200],"Insulin Resistance",[202,203,91,29,200,204,205],"SCUBE-1","SCUBE-3","Inflammation","Cardiovascular Risk","2026-02-02",{"date":178,"type":39},{"date":209,"type":23},"2026-01-15",{"date":211,"type":23},"2026-07-01",{"name":213,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":59,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":231,"locationsCount":47},"100619920","effects-of-a-specific-dietary-program-on-overweightobese-women-with-polycystic-ovary-syndrome-a-multicenter-prospective-randomized-controlled-clinical-study-100619920","NCT07350889","Effects of a Specific Dietary Program on Overweight\u002FObese Women With Polycystic Ovary Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Study","Inclusion Criteria:\n\n1. Female participants aged 18-49 years.\n2. Body mass index (BMI) ≥ 24 kg\u002Fm² and waist circumference ≥ 85 cm.\n3. Diagnosis of polycystic ovary syndrome (PCOS) based on the 2003 Rotterdam consensus, defined by the presence of at least two of the following three criteria: (i) Oligo-ovulation and\u002For anovulation; (ii) Clinical and\u002For biochemical signs of hyperandrogenism; (iii) Polycystic ovarian morphology on ultrasonography, defined as the presence of ≥12 follicles measuring 2-9 mm in diameter in each ovary and\u002For increased ovarian volume ≥10 cm³.\n4. Menstrual irregularity.\n5. Use of reliable non-hormonal contraception throughout the study period.\n6. Provision of written informed consent.\n\nExclusion Criteria:\n\n1. Participants with non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or adrenal tumors will be excluded from the study.\n2. Participants who are postmenopausal or perimenopausal, as well as those who are pregnant, planning pregnancy, or currently lactating, will be excluded.\n3. Participants with a history of substance abuse, acute infectious diseases, or diabetes mellitus will not be eligible for inclusion.\n4. Participants with a history of malignancy within the past 5 years or with current malignant disease will be excluded.\n5. Participants with a history of gallstones or gout will be excluded from the study.\n6. Participants with poorly controlled thyroid disorders, regardless of etiology, will be excluded.\n7. Participants who have been diagnosed with an eating disorder within the past 12 months will be excluded.\n8. Participants with known intolerance or allergy to components of the study dietary plan, such as soy, lactose, or gluten, or those diagnosed with celiac disease, will be excluded.\n9. Participants who have used medications that may affect reproductive or metabolic outcomes within the past 3 months will be excluded, including oral hormonal contraceptives or hormonal implants; anti-androgens (e.g., spironolactone, flutamide, finasteride); metformin or other insulin-sensitizing agents; clomiphene citrate or estrogen modulators; gonadotropin-releasing hormone (GnRH) modulators (e.g., leuprolide); minoxidil; weight-loss medications; or other drugs that may influence appetite, such as oral corticosteroids.\n10. Participants with severe hepatic impairment, defined as alanine aminotransferase (ALT) \\> 100 U\u002FL or aspartate aminotransferase (AST) \\> 100 U\u002FL, will be excluded.\n11. Participants with severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) \\\u003C 80 mL\u002Fmin, will be excluded.\n12. Participants with severe cardiovascular or cerebrovascular disease, including unstable angina, heart failure classified as New York Heart Association (NYHA) class III or higher, or those in the acute phase of cerebral infarction, will be excluded.\n13. Participants who are currently participating in another clinical trial will be excluded.\n14. Participants with any other medical condition or circumstance that, in the opinion of the investigators, makes them unsuitable for participation will be excluded.","49 Years",{"count":222,"type":23},160,[61],"The goal of this clinical trial is to investigate the effects of a specific dietary program on overweight or obese patients with polycystic ovary syndrome (PCOS) through a multicenter, randomized, controlled, prospective study design.\n\nThe main questions it aims to answer are:\n\n1. Does the specific dietary program increase the clinical remission rate of PCOS in overweight or obese patients?\n2. Does the specific dietary program improve metabolic and anthropometric outcomes in overweight or obese patients with PCOS compared with conventional intervention?\n\nResearchers will compare the effects of a specific dietary program versus conventional intervention on clinical remission rates, metabolic outcomes, and anthropometric measures in overweight or obese patients with PCOS.\n\nParticipants will:\n\n1. Receive either a specific dietary intervention or conventional intervention for 24 weeks.\n2. Undergo assessments every 12 weeks throughout the study period.",[27],"2026-01-09",{"date":182,"type":39},{"date":209,"type":23},{"date":230,"type":23},"2027-12-31",{"name":232,"class":46},"Xuanwu Hospital, Beijing",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":139,"minAge":19,"maxAge":220,"enrollmentInfo":241,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":47},"100619077","phenotyping-of-patients-with-polycystic-ovary-syndrome-100619077","NCT07339930","Phenotyping of Patients With Polycystic Ovary Syndrome","Phenotyping of Patients With Polycystic Ovary Syndrome (PCOS) in Alsace, France","SOPK","Inclusion Criteria:\n\n* Adult woman (≥18 years and \\\u003C50 years)\n* Subject who consulted at the Strasbourg University Hospitals for suspected PCOS or for any other endocrinological condition that led to the discovery of PCOS.\n\nExclusion Criteria:\n\n* Final diagnosis excluding PCOS.",{"count":88,"type":23},"Polycystic ovary syndrome (PCOS) is the leading endocrine disorder of the reproductive system, affecting 10 to 13% of women of childbearing age. However, there is a significant delay in diagnosis, which may be due to considerable clinical heterogeneity and a lack of information among the general population. The diagnosis is made when two of the three Rotterdam criteria established in 2003 and revised in 2023 are met, namely: 1) menstrual cycle disorders (oligoanovulation) - 2) clinical or biological hyperandrogenism - 3) OPK morphological appearance or elevated anti-Müllerian hormone (AMH) levels, after exclusion of differential diagnoses. PCOS is a condition that carries a risk of metabolic complications and fertility problems due to dysovulation. Patients have an impaired quality of life and are at greater risk of anxiety and depression, which should be screened for systematically.",[27],[245,246,247,248,249],"Polycystic ovary syndrome (PCOS)","Polycystic Ovary","Endocrine disorder","Menstrual cycle disorders","Anti-Müllerian hormone (AMH)","2026-01-05",{"date":252,"type":39},"2026-01-14",{"date":254,"type":39},"2025-09-17",{"date":256,"type":23},"2026-09-17",{"name":258,"class":46},"University Hospital, Strasbourg, France",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":267,"targetDuration":4,"studyType":59,"phases":269,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":289},"100618014","phase-4-a-clincial-study-testing-tirzepatide-on-reproductive-function-and-metabolic-health-in-women-with-pcos-who-are-overweight-or-obese-100618014","NCT07326111","A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese","A Clinical Trial of Tirzepatide (LY3298176) in Subjects With Overweight or Obesity and PCOS-related Ovarian Dysfunction","PERIODS","General Inclusion Criteria\n\n* Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial\n* Subjects\n\n  * motivated, capable, and willing to self-inject IMP, as required for this protocol.\n  * motivated, capable, and willing to follow trial procedures for the duration of the clinical trial, includ-ing, but not limited to lifestyle, dietary and exercise advice.\n  * motivated, capable, and willing to complete trial diaries and required questionnaires.\n\nIndication-specific Inclusion Criteria\n\n* Females aged 18 - 45 years of childbearing potential\n* At least 3 years post-menarche and premenopausal\n* BMI ≥ 27 kg\u002Fm²\n* Previous diagnosis of PCOS, defined by Rotterdam criteria\n* Oligomenorrhea or secondary amenorrhea with irregular periods (defined as cycle length less than 21 or more than 35 days or \\\u003C 8 cycles per year); within the last 10 years (if currently receiving hormonal contraceptive treatment) OR over the last year in the absence of hormonal contraceptive treatment\n* Biochemical signs of hyperandrogenism with total testosterone in upper 95th Percentile AND free androgen index (FAI) \\> ULN and\u002For clinical signs of hyperandrogenism\n* Hormonal contraceptive naïve or not on hormonal contraceptives six months prior to screening, willing to be without hormonal contraceptives for the duration of the clinical trial and to perform safe alternate contraception (barrier methods) during the 72-week IMP intake period and 30 days after the last dose of IMP\n\nGeneral Exclusion Criteria\n\n* Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial\n* Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial\n\n  * Note: Patients with depression or other psychiatric disorder whose disease state is considered stable and expected to remain stable throughout the course of the clinical trial, in the opinion of the investigator, may be considered for inclusion.\n  * Note: Subjects with a lifetime suicidal event cannot be considered for inclusion\n* Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investiga-tional product, up to 30 days after last IMP intake in that clinical trial\n* Known or persistent abuse of medication, drugs or alcohol\n* History of an active or untreated malignancy or being in remission from a clinically significant malig-nancy for less than 5 years\n\n  o Excluding basal- or squamous-cell skin cancer or in situ carcinomas of the cervix\n* Prior diagnosis of severe renal impairment or measured as estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m² during screening\n* Acute or chronic hepatitis, signs and symptoms of any other liver disease other than non-alcoholic fatty liver disease, or alanine aminotransferase (ALT) level \\> 3.0 X the upper limit of normal, as deter-mined by the laboratory during screening\n* History of gastric emptying abnormality (e.g., gastroparesis, gastric outlet obstruction or chronic de-pendence on drugs that significantly affect gastric emptying)\n* Current (positive pregnancy test, e.g., ß-HCG test in urine \u002F serum) or planned pregnancy during the 72-week treatment period from randomization, or nursing women\n\nIndication-specific Exclusion Criteria\n\n* Prior diagnosis of diabetes mellitus other forms than type 2\n\n  o Note: Excluding prior history of gestational diabetes\n* In case of diabetes mellitus type 2, exclusion of subjects\n\n  * on DPP-4 inhibitors, GLP-1R agonist and\u002For a dual\u002Ftriple incretin agonist (up to 6 months prior to screening)\n  * on sulfonylureas or insulin (basal and\u002For bolus)\n  * with uncontrolled diabetes (HbA1c \\> 8.5%)\n  * with non-proliferative diabetic retinopathy requiring acute treatment\n  * with diabetic maculopathy\n  * Note: use of metformin or SGLT-2-inhibitor (if needed for glycemic control in type-2-diabetes) is allowed\n* Current or prior treatment (up to 6 months prior to screening) with GLP-1R agonist or a dual incretin agonist for obesity or other indications\n* Use of inositol formulations (up to 6 months prior to screening)\n* Congenital adrenal hyperplasia (CAH, classic and non-classic forms)\n* Thyroid, pituitary, and\u002For adrenal disease (if not appropriately treated)\n\n  o Note: Excluding stable disease and\u002For stable drug dose 12 weeks before screening\n* Hyperprolactinaemia\n* Known history of benign intrauterine lesions\n* Hysterectomy\n* Known history of hypersensitivity against tirzepatide or excipients\n* Known history of hypersensitivity against medroxyprogesterone acetate or dydrogesterone or any other ingredients of the Auxiliary Medicinal Products\n* Known personal or family history of medullary thyroid cancer or subjects with Multiple Endocrine Ne-oplasia syndrome type 2 (MEN 2)\n* Elevated calcitonin levels as determined by the laboratory during screening\n\n  * ≥ 20 ng\u002FL, if eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2\n  * ≥ 35 ng\u002FL, if eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n* Known secondary cause of obesity (i.e., Cushing syndrome) or monogenetic or syndromic forms of obesity (i.e., melanocortin 4 receptor deficiency or Prader Willi Syndrome)\n* Known history of acute or chronic pancreatitis\n* Previous or planned bariatric surgery or endoscopic and\u002For device-based therapy for obesity\n\n  o Note: excluding liposuction or abdominoplasty if performed \\> 1 year prior to screening\n* Vaginal bleeding of unknown cause\n* Known thromboembolic events or active thrombophlebitis",{"count":268,"type":23},198,[270],"PHASE4","This clinical study examines whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome (PCOS) who are overweight or have obesity. Tirzepatide is already approved for the treatment of diabetes and obesity, but its effects on ovarian dysfunction in PCOS are not yet known. Participants will be randomly assigned to tirzepatide or placebo in a double-blinded manner.\n\nThe goal of the study is to demonstrate that tirzepatide, at the maximum tolerated dose, is superior to placebo for improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS.\n\nAll participants will have a screening visit, followed by 72 weeks of treatment. Treatment includes a 20-week dose-escalation period and a 52-week maintenance period. Lower doses may be used if side effects occur, and the highest tolerated dose will be continued through the maintenance phase. A 4-week safety follow-up will take place after treatment, and long-term follow-up will continue for one year. The study will take place at five clinical trial sites in Germany.",[27,273],"Obesity & Overweight",[275,276,277,278,279],"pcos","tirzepatide","obesity","reproductive health","polycystic ovary syndrome","2025-12-23",{"date":282,"type":39},"2026-01-08",{"date":284,"type":39},"2025-12-09",{"date":286,"type":23},"2029-12",{"name":288,"class":46},"University of Bonn",2,{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":18,"minAge":297,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":59,"phases":301,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":47},"100615896","effect-of-magnesium-and-levocarnitine-on-metabolic-and-clinical-outcomes-in-women-with-polycystic-ovarian-syndrome-pcos-100615896","NCT07298564","Effect of Magnesium and Levocarnitine on Metabolic and Clinical Outcomes in Women With Polycystic Ovarian Syndrome (PCOS)","Assessment of the Effect of Magnesium and Levocarnitine Co-supplementation on Lipid Profile, Glycemic Control Indicators and Hirsutism in Women With Polycystic Ovarian Syndrome","Inclusion Criteria:\n\n* Age between 19 and 65 years.\n* Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.\n\nExclusion Criteria:\n\n* Hypothyroidism\n* Menopause\n* Pregnancy or breastfeeding\n* Renal (kidney) dysfunction\n* Use of therapeutic vitamin or mineral supplements\n* Liver diseases (e.g., grade 3 fatty liver, hepatitis, or cirrhosis)\n* Psychiatric disorders such as bipolar disorder\n* Neuromuscular diseases (e.g., myasthenia gravis, Parkinson's disease, multiple sclerosis, epilepsy, or muscular dystrophy)\n* History of seizures\n* Participants who become pregnant during the study or fail to comply with more than 20% of the study protocol will be withdrawn from the study","19 Years","65 Years",{"count":300,"type":23},84,[61],"Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age and is associated with metabolic abnormalities such as insulin resistance, dyslipidemia, and hormonal imbalance, which may lead to infertility and hirsutism. Despite the availability of several pharmacological treatments, many therapies fail to effectively address the underlying metabolic and endocrine dysfunctions of PCOS. Magnesium and L-carnitine are two essential nutrients that may play a synergistic role in improving insulin sensitivity, glucose metabolism, and lipid profile, as well as reducing oxidative stress and androgen production in women with PCOS. This randomized, triple-blind, placebo-controlled clinical trial aims to evaluate the effects of co-supplementation with magnesium and L-carnitine on glycemic control indices, lipid profile, and hirsutism in women with PCOS. A total of 84 eligible women aged 19-65 years diagnosed with PCOS according to the Rotterdam criteria will be recruited from Shohada Tajrish Hospital, Tehran, Iran. Participants will be randomly assigned to one of three groups: (1) magnesium supplementation (500 mg\u002Fday, in two 250 mg doses) plus L-carnitine placebo, (2) L-carnitine supplementation (1000 mg\u002Fday) plus magnesium (500 mg\u002Fday), or (3) placebo control group. The intervention period will last 12 weeks. Physical activity information will be collected using short form of International Physical Activity Questionnaire (IPAQ) and demographic information through a general information questionnaire. In order to evaluate dietary intake of patients in terms of energy(kcal\u002F(day), carbohydrate(gr\u002Fday), protein(gr\u002Fday), fat intake(gr\u002Fday), saturated fatty acids (SFA) (gr\u002Fday), monounsaturated fatty acids (MUFA) (gr\u002Fday), polyunsaturated fatty acids (PUFA)(gr\u002Fday), Vitamin E (mg\u002Fday), Vitamin C (mg\u002Fday), Beta-carotene (mg\u002Fday) and Vitamin A (mg\u002Fday), cupper intake (mg\u002Fday), selenium intake (mg\u002Fday), and zink intake (mg\u002Fday), 24-hr recalls will be completed by interviewing the patient for 3 days (two normal days and a weekend day). Weight will be measured with the minimum dress and without shoes by using a digital balance scale of 100 grams and height will be measured without shoes by meters mounted to the wall with an accuracy of 0.5 centimeters. Then the body mass index will be calculated by dividing the weight (kg) by the square of the height (m), waist circumference will be measured in the narrowest area between the lowest lumbar spine and the iliac bone (cm), systolic and diastolic blood pressure will be measured after 15 minutes of rest, twice using the mercuric barometric measure and the mean will be reported as individual blood pressure. The blood sample will be taken after 12 hours of overnight fasting in three groups for measuring Fasting Blood Sugar (FBS) (mg\u002FdL), lipid profile (mg\u002FdL), Hemoglobin A1c (HbA1C) (percentage), serum insulin concentration (µIU\u002Fml) and insulin resistance. Insulin resistance will be calculated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) formula, and hirsutism score (using the modified Ferriman-Gallwey method) will be assessed at baseline and post-intervention. At the end of the study, counting the remaining capsules, the patient's compliance rate will be evaluated, and patients who have consumed less than 90% of their capsules will be excluded from the analysis.",[27],[91,146,200,305,306],"Dyslipidemia","Hirsutism","2025-12-22",{"date":280,"type":39},{"date":310,"type":23},"2026-01-30",{"date":312,"type":23},"2026-11-30",{"name":314,"class":46},"Behnood Abbasi",{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":171,"enrollmentInfo":322,"targetDuration":4,"studyType":59,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":289},"100613412","effect-of-levocarnitine-plus-myoinositol-versus-myoinositol-alone-on-hormonal-and-insulin-resistance-in-pcos-women-100613412","NCT07266259","Effect of Levocarnitine Plus Myoinositol Versus Myoinositol Alone on Hormonal and Insulin Resistance in PCOS Women","Effects of Levocarnitine and Myoinositol in Comparison to Myoinositol Alone on Hormonal and Insulin Resistance Parameters in Subfertile Women With Insulin Resistant Polycystic Ovary Syndrome","Inclusion Criteria:\n\n* Age:18-40 years old.\n* Diagnosed cases of PCOS patients(both old \\& new cases) according to International evidence-based guideline criteria 2023\n* Primary or secondary subfertility.\n* Insulin resistance (HOMA-IR \\>2.6)\n\nExclusion Criteria:\n\n* Hypothyroidism\n* Diabetes mellitus\n* Hormonal (Myo-inositol,D-chiro-inositol) or insulin sensitizing drugs like Metformin,Pioglitazone etc. treatment in the last three months\n* Known hypersensitivity to Myo-inositol and Levo-carnitine\n* Pregnancy",{"count":323,"type":23},72,[61],"The goal of this clinical trial is to learn if combination of levocarnitine and myoinositol works better than myoinositol alone on insulin resistance and hormonal parameters in subfertile women with insulin resistant polycystic ovary syndrome . It will also learn about the safety of drug levocarnitine and myoinositol. The main questions it aims to answer are:\n\nDoes combined action of levocarnitine and myoinositol improve insulin resistance and hormonal parameters in comparison to myoinositol alone in subfertile women with insulin resistant polycystic ovary syndrome ? What medical problems do participants have when taking drug levocarnitine and myoinositol? Researchers will compare the drug combination of levocarnitine and myoinositol to myoinositol alone to see if combination therapy works better?\n\nParticipants will:\n\nTake drug levocarnitine and myoinositol or a myoinositol alone twice daily for 3 months Visit the clinic once after 3 months for checkups and tests Keep a diary of their symptoms and the number of times.",[27],[328,329,279],"levocarnitine myoinositol","insulin resistance hormonal parameters","2025-12-13",{"date":332,"type":39},"2025-12-19",{"date":334,"type":39},"2025-09-19",{"date":336,"type":23},"2027-03-01",{"name":338,"class":46},"Mst.Sumyara Khatun",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":171,"enrollmentInfo":346,"targetDuration":4,"studyType":59,"phases":348,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":360,"locationsCount":47},"100611557","efficacy-of-oral-contraceptive-progesterone-and-inositol-on-menstrual-regulation-in-pcos-100611557","NCT07242131","Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS","Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)","Inclusion Criteria:\n\n* Female participants aged 18 to 40 years.\n* Diagnosed with polycystic ovary syndrome (PCOS) according to the ESHRE\u002FASRM (Rotterdam) criteria (presence of at least two of the following: oligo\u002Fanovulation, clinical or biochemical hyperandrogenism, polycystic ovarian morphology).\n* No significant comorbid systemic disease.\n* Willingness to participate and ability to provide written informed consent.\n* Regular follow-up availability for at least 6 months.\n\nExclusion Criteria:\n\n* Known hepatic, renal, cardiovascular, or endocrine disorders other than PCOS.\n* Pregnancy or current use of hormonal therapy within the past 3 months.\n* History of thromboembolic disease, breast cancer, or other contraindications to hormonal treatment.\n* Inability to adhere to follow-up visits or treatment regimen.\n* Severe cognitive or communication impairment that prevents proper consent or data collection.\n* Known allergy or hypersensitivity to any component of the study drugs.\n* Participation in another interventional study within the past 3 months.",{"count":347,"type":23},150,[61],"This cross-sectional study aims to compare the effectiveness of oral contraceptives, oral progesterone (didrogesterone), and inositol in regulating menstrual cycles among women diagnosed with polycystic ovary syndrome (PCOS).\n\nPCOS is a common endocrine disorder affecting reproductive-aged women and is associated with menstrual irregularities, hyperandrogenism, and polycystic ovarian morphology. While oral contraceptives are the mainstay of treatment, their use may be contraindicated in patients with cardiovascular risk factors, liver dysfunction, or in those who desire pregnancy.\n\nThis study investigates whether oral progesterone and myo-inositol can serve as effective and safer alternatives for menstrual regulation and improvement of ovarian morphology and hyperandrogenic symptoms.\n\nA total of 150 women aged 15-40 years with a diagnosis of PCOS will be enrolled and divided into three equal groups:\n\nGroup 1: Oral contraceptive users\n\nGroup 2: Oral progesterone users\n\nGroup 3: Inositol users The study will assess changes in menstrual regularity, ovarian morphology (via ultrasound), and clinical features such as hirsutism and acne before and after treatment.",[27],[91,352,353],"Menstrual Cycle","Didrogesterone","2025-12-10",{"date":356,"type":39},"2025-12-18",{"date":358,"type":39},"2025-12-01",{"date":41,"type":23},{"name":361,"class":46},"Ege University",{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":59,"phases":373,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":47},"100606162","ivm---fresh-et-the-saigon-protocol-versus-ivf---fet-in-pcos-women-100606162","NCT07171970","IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women","The Effectiveness and Safety of In Vitro Maturation With Fresh Embryo Transfer (The SAIGON Protocol) Versus In Vitro Fertilization With Frozen Embryo Transfer in Women With Polycystic Ovary Syndrome","SAIGON-PTC","Inclusion Criteria:\n\n* Women aged 18 - 42 years old.\n* Diagnosed with PCOS, followed Rotterdam 2003 criteria (Group TREP consensus workshop, 2004)\n* Had fewer than three previous failed frozen embryo transfer (FET) cycles\n* Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts.\n* Agreeing to participate in the study\n\nExclusion Criteria:\n\n* Having allergy and contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)\n* Cycles with preimplantation genetic testing indication\n* Oocyte donation cycles\n* Having untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate\u002F bicornuate\u002F arcuate uterus, large leiomyoma ≥5 cm in diameter; adenomyosis, endometrial polyp, hydrosalpinx).","42 Years",{"count":372,"type":23},600,[61],"Assisted Reproductive Technologies (ART) aim to increase success rates while minimizing patient risks. For women with high AFC or PCOS, conventional IVF carries a high risk of OHSS (Ho et al., 2019). A modern IVF strategy to prevent this uses a GnRH agonist trigger, requiring a \"freeze-all\" and subsequent FET (Wong et al., 2017). This reduces OHSS risk but can increase time to pregnancy (Vuong et al., 2021) and treatment burden.\n\nIVM is a patient-friendly alternative that eliminates OHSS risk by avoiding high-dose gonadotropins. A 2020 trial by Vuong et al. compared CAPA-IVM-FET to conventional IVF-FET in women with high AFC. IVM yielded a comparable live birth rate (35.2%) versus IVF (43.2%), with a 0% OHSS rate in IVM compared to 0.7% in IVF (Vuong et al., 2020).\n\nThe optimal transfer method (fresh or frozen) in IVM cycles is debated. A 2021 pilot RCT by Vuong et al. found a freeze-only strategy after CAPA-IVM led to a significantly higher live birth rate (60%) than a fresh transfer (20%) (Vuong et al., 2021), but increased time to pregnancy (194 vs. 150 days) (Vuong et al., 2021). A refined CAPA-IVM protocol, which uses no gonadotropins, allowed for fresh embryo transfer in the same cycle, resulting in a numerically higher ongoing pregnancy rate (43.3% vs. 33.3%) than FET (Vuong et al., 2025).\n\nThis raises an important question: how does a simplified IVM strategy with fresh transfer compare to the established \"safety-net\" IVF strategy with FET? These two approaches represent opposing clinical philosophies. No large-scale study has yet compared them in women with PCOS. Therefore, this study is designed to compare the SAIGON protocol (gonadotropin-free CAPA-IVM with fresh ET) against a standard GnRH-antagonist IVF protocol with agonist trigger and subsequent FET.",[27,376,377],"In Vitro Maturation of Oocytes","Fresh Embryo Transfer",[379,380,381,382,383],"in vitro maturation","The SAIGON protocol","fresh embryo transfer","GnRH-Antagonist","frozen embryo transfer","2025-09-30",{"date":386,"type":39},"2025-10-01",{"date":388,"type":39},"2025-09-22",{"date":390,"type":23},"2028-01-15",{"name":392,"class":46},"Mỹ Đức Hospital",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":400,"enrollmentInfo":401,"targetDuration":4,"studyType":59,"phases":402,"briefSummary":403,"conditions":404,"keywords":405,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":289},"100605146","protein-and-polycystic-ovary-syndrome-pcos-100605146","NCT07158723","Protein and Polycystic Ovary Syndrome (PCOS)","Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)","Inclusion Criteria:\n\n* Females ages 18-50 years\n* Confirmed diagnosis of PCOS\n* Body mass index (BMI) between 18.5 and 35 kg\u002Fm2\n* Stable body weight for at least 3 months (+ 5 pounds)\n* Willingness to consume both plant- and animal-based protein meals\n\nExclusion Criteria:\n\n* Smoking or use of nicotine products\n* Smoking, vaping, and\u002For use of marijuana products\n* More than 4 alcoholic beverages per week\n* Food allergies or dietary restrictions incompatible with test meals\n* Diagnosed diabetes (type 1 or 2) or other preexisting chronic disease(s).\n* Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)\n* Consumption of more than 0.8 g\u002Fprotein\u002Fkg body weight\n* Underweight\n* Taking nutritional supplements","50 Years",{"count":141,"type":23},[61],"Polycystic ovary syndrome (PCOS) is a significant public health problem and is one of the most common hormonal disturbances affecting women of reproductive age. Women with PCOS are often insulin resistant, increasing their risk for cardiometabolic health problems (e.g., type 2 diabetes, heart disease, high blood pressure, sleep apnea, anxiety, depression, and stroke) especially if they are overweight. Lifestyle modifications, including dietary changes and regular physical activity, may alleviate metabolic dysfunction in women with PCOS and are often the first line of management for patients with PCOS. Several studies have identified protein as a key nutrient for regulation of energy balance, maintenance of skeletal muscle mass, and improving cardiometabolic health across the lifespan. However, the effect of increased protein intake (30% of total energy intake) on cardiometabolic health in women with PCOS has not been well-defined and mechanisms for these effects have not been identified.\n\nThere is an evident need for well-designed, randomized controlled trials evaluating the efficacy of increased protein intake in women with PCOS on markers of cardiometabolic health. Preliminary data from collaborative projects with the investigators on this proposal suggest that increasing protein in the diet has the potential to improve markers of cardiometabolic health, potentially through improvements in body composition and\u002For changes in cortisol, energy metabolism, inflammation, and neurological regulators",[27],[29,279,406,407,408,409],"protein","women","wellbeing","metabolism","2025-09-02",{"date":412,"type":39},"2025-09-08",{"date":414,"type":39},"2025-08-01",{"date":416,"type":23},"2027-12-03",{"name":418,"class":46},"University of Arkansas, Fayetteville",{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":400,"enrollmentInfo":426,"targetDuration":4,"studyType":59,"phases":428,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":47},"100603906","appetite-response-to-meals-with-different-protein-sources-in-women-with-pcos-100603906","NCT07142603","Appetite Response to Meals With Different Protein Sources in Women With PCOS","Comparative Meal Response to Plant vs. Animal Protein in Women With PCOS","Inclusion Criteria:\n\n* Females ages 18-50 years\n* Confirmed diagnosis of PCOS\n* Body mass index (BMI) between 18.5 and 35 kg\u002Fm2\n* Stable body weight for at least 3 months (+ 5 pounds)\n* Willingness to consume both plant- and animal-based protein meals\n\nExclusion Criteria:\n\n* Smoking or use of nicotine products\n* Smoking or use of marijuana products\n* Food allergies or dietary restrictions incompatible with test meals\n* Diagnosed diabetes (type 1 or 2)\n* Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)",{"count":427,"type":23},30,[61],"Polycystic ovary syndrome (PCOS) is a common endocrine disorder characterized by insulin resistance, hyperandrogenism, and reproductive dysfunction. Dietary strategies that improve postprandial insulin and glucose responses are central to managing metabolic symptoms in PCOS.\n\nMeals higher in protein can attenuate postprandial glycemia and enhance satiety, but the effects may vary by protein source. Animal sources of protein typically have higher essential amino acid content and insulinogenic potential, whereas plant proteins offer fiber and phytochemicals that may influence glycemic dynamics differently. Few studies have directly compared the acute metabolic effects of plant versus animal protein in women with PCOS. Given the distinct pathophysiology of PCOS, extrapolating findings from healthy populations may be misleading.\n\nUnderstanding protein-specific effects on postprandial insulin, glucose, and appetite-regulating hormones in this group is essential for targeted nutrition guidance. Additionally, plant-based diets are increasingly promoted for cardiometabolic health, but their acute effects in insulin-resistant women remain underexplored. This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform dietary recommendations aimed at improving metabolic outcomes in this high-risk population.",[27],[29,279,432,433],"Protein","Women","2025-08-25",{"date":410,"type":39},{"date":437,"type":39},"2025-08-18",{"date":439,"type":23},"2027-06-30",{"name":418,"class":46},{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":59,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":47},"100602893","strengthening-healthy-emotional-co-regulation-of-mothers-with-pcos-and-obesity-and-their-infants-100602893","NCT07129434","Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants","ECoFam","Inclusion Criteria:\n\n* Diagnosis of PCOS\n* Obesity according to BMI\n* Gave birth at Oulu University Hospital in 2024-25\n* PEPPI cohort study participation\n* uWECS emotional connection score \\\u003C9.0 at pre-test\n\nExclusion Criteria:\n\n\\- Infant death",{"count":449,"type":23},40,[61],"It is both timely and important to invest in interventions that can improve healthy emotional co-regulation. It is proposed to evaluate the feasibility and limited efficacy of an adapted, brief, multimodal intervention: ECoFam (Emotional connection and Co-regulation for Families). Evidence from the US suggests intervention effects on maternal and infant outcomes that are large in effect size (i.e., Cohen's d \\>0.6 for increasing emotional connection and decreasing maternal depressive symptoms) (21-23). The study results will directly translate evidence into practice and, if found feasible, allow rapid scaling-up.\n\nObjectives:\n\n1. Build capacity for implementation of a novel diagnostic screening tool for emotional co-regulation, the uWECS, as part of clinical follow-up for mother-infant dyads with high fibrobesity risk in Finland.\n2. Test the feasibility and limited efficacy of the brief, multimodal ECoFam intervention to foster healthy emotional co-regulation between mothers with PCOS and obesity and their infants.",[27,453],"Obesity &Amp;Amp; Overweight","2025-08-11",{"date":456,"type":39},"2025-08-19",{"date":458,"type":39},"2025-04-15",{"date":460,"type":23},"2026-12",{"name":462,"class":46},"Oulu University Hospital",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":471,"enrollmentInfo":472,"targetDuration":4,"studyType":59,"phases":474,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":487,"locationsCount":47},"100602231","phase-3-optimizing-metformin-use-in-polycystic-ovary-syndrome-100602231","NCT07120815","Optimizing Metformin Use in Polycystic Ovary Syndrome","Optimizing Metformin Use in Polycystic Ovary Syndrome - A Randomized Controlled Trial","MET-PCOS","Inclusion Criteria:\n\n* Diagnosed PCOS (According to the International evidence-based Guideline for PCOS 2023)\n* Age: 18-37 years\n* BMI: ≥ 25 and \\\u003C40 kg\u002Fm2\n* Signed informed consent and willingness to comply with the trial procedures\n* Sufficient skills in the Finnish or Swedish language\n\nExclusion Criteria:\n\n* Not meeting the criteria according to the International evidence-based Guideline for PCOS 2023)\n* Use of hormonal contraceptive during the last 3 months\n* Pregnancy\n* Breastfeeding\n* Untreated diabetes\n* Hypothyroidism\n* Hyperprolactinemia\n* Use of medications for diabetes,\n* Use of medications for high cholesterol\n* Use of medications for obesity\n* Use of medications for cortisone (per oral)\n* Hypersensitivity to metformin\n* Acute metabolic acidosis\n* Renal impairment\n* Hepatic insufficiency\n* Heart- or respiratory failure\n* Serious mental illness\n* Alcoholism\n* Investigator site staff directly involved in the conduct of the study and their family members","37 Years",{"count":473,"type":23},184,[475],"PHASE3","The goal of this clinical trial is to learn if a metformin dose of 1500 mg or 2250 mg per day is better to treat polycystic ovary syndrome (PCOS) in adults. It will also learn about the adverse effects of metformin. The trial aims to evaluate which metformin dose is better for:\n\n1. improving biochemical and clinical outcomes\n2. gastrointestinal side-effects\n3. mental health and quality of life\n\nParticipants will:\n\n* Be randomized to take metformin at a dose of either 1500mg or 2250mg every day for 6 months\n* Visit the clinic three times during the trial for checkups and tests\n* Answer questionnaires on menstrual cyclicity, mental health, quality of life and side-effects",[27],[279,479,480],"metformin","randomized controlled trial","2025-08-06",{"date":483,"type":39},"2025-08-13",{"date":485,"type":23},"2025-09-01",{"date":160,"type":23},{"name":488,"class":46},"Helsinki University Central Hospital",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":171,"enrollmentInfo":495,"targetDuration":4,"studyType":59,"phases":497,"briefSummary":499,"conditions":500,"keywords":501,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":47},"100601169","early-phase-1-mechanism-of-red-yeast-rice-regulating-intestinal-indole-metabolism-pathway-to-improve-chronic-inflammation-in-polycystic-ovary-syndrome-100601169","NCT07106996","Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome","Inclusion Criteria\n\n* Female patients aged 18-40 years old\n* Meeting the Rotterdam criteria (at least two of the following):\n* Anovulation or oligo-ovulation\n* Clinical evidence of hyperandrogenism or hyperandrogenemia\n* Ultrasound findings indicating polycystic ovarian morphology (defined as at least 12 follicles measuring 2-9 mm in diameter and\u002For an ovarian volume \\>10 mL \\[length × width × thickness \u002F 2\\] in one ovary)\n* Subjects who have been fully informed of the study procedures and related risks, and voluntarily agree to participate\n\nExclusion Criteria\n\n* Pregnant women (confirmed via urine\u002Fserum hCG)\n* Patients with concomitant infectious diseases or severe dysfunction of multiple systemic organs\n* Patients who have taken antibiotics or other drugs (such as probiotics, prebiotics, etc.) that can alter the composition of intestinal flora within 3 months before enrollment",{"count":496,"type":23},90,[498],"EARLY_PHASE1","The aim of this study is to elucidate the effects of red yeast rice on the improvement of symptoms in patients with polycystic ovary syndrome（PCOS）, and to analyze the dose-response relationship between intestinal microbiota and its metabolite, hydroxyindole, and clinical indicators of PCOS.\n\nThe main questions it aims to answer are:\n\nHow effective is red yeast rice in treating PCOS? Does the indole metabolic pathway of gut microbiota play a crucial role in the improvement of PCOS symptoms by red yeast rice? Participants will take 6 grams of red yeast rice daily for 6 months, and records will be kept of their PCOS clinical symptoms and indicators before the intervention, at the 3rd month post-intervention, and at the 6th month post-intervention. Additionally, biological samples from feces and serum will be collected at these time points.",[27],[502,503,504,505],"Polycystic ovary syndrome","red yeast rice","intestinal microbiota","indole metabolism","2025-08-05",{"date":481,"type":39},{"date":509,"type":39},"2025-07-28",{"date":511,"type":23},"2026-08-01",{"name":513,"class":46},"Sichuan Provincial People's Hospital",{"id":515,"slug":516,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":171,"enrollmentInfo":521,"targetDuration":4,"studyType":59,"phases":522,"briefSummary":524,"conditions":525,"keywords":526,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100580839","phase-2-dihydroartemisinin-for-the-treatment-of-polycystic-ovary-syndrome-100580839","NCT06842524","Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome","Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome: a Multi-centre Placebo-controlled Randomized Clinical Trial","Inclusion Criteria:\n\n* Women with PCOS defined as having irregular menstrual cycles and hyperandrogenism. Irregular menstrual cycles are defined as \\\u003C 21 or \\> 35 days or \\\u003C 8 cycles per year. Hyperandrogenism refers to either hyperandrogenemia or hirsutism. Hyperandrogenemia will be defined as an elevated total testosterone \\>1.67 nmol\u002FL measured by Elecsys Testosterone II (Roche Diagnostics). Hirsutism is determined by a modified Ferriman-Gallwey Score \\>4 at screening exam.\n* Body Mass Index (BMI) between 18.5 and 28 kg\u002FM2\n* Negative pregnancy test\n* No plan for pregnancy in the coming 6 months\n\nExclusion Criteria:\n\n* Patients on oral contraceptives. A two-month washout period will be required prior to screening for patients on these agents. A one-month washout will be required for patients on oral cyclic progestins. Patients on depo-progestins or hormonal implants are excluded.\n* Patients with liver disease defined as ALT or AST above normal range of each participating center, or total bilirubin\\>30umol\u002FL. Metabolic dysfunction-associated steatotic liver disease (MASLD) with normal ALT and AST can be included.\n* Patients with anemia (Hemoglobin \\\u003C 12 g\u002FdL) or neutropenia (neutrocyte \\\u003C1.8×10\\^9\u002FL).\n* Patients with renal disease defined as serum creatinine\\> 115umol\u002FL.\n* Patients diagnosed with other endocrine diseases that are known to cause secondary polycystic ovary morphology, e.g., Cushing's syndrome, hyperprolactinemia, congenital adrenal hyperplasia (21-hydroxylase deficiency or other enzyme deficiency), hypothyroidism, etc.\n* Patients diagnosed with Type 1 or Type 2 diabetes.\n* Patients with known heart disease, like heart failure, atrial fibrillation, coronary heart disease, etc.\n* Patients with a history of any type of cancer.\n* Patients taking other medications known to affect reproductive function or metabolism. These medications include GnRH agonists and antagonists, antiandrogens, gonadotropins, GLP-1 receptor agonist, SGLT2i, metformin and thiazolidinediones. The washout period on all these medications will be two months.\n* Patients who have undergone a bariatric surgery procedure within the past 12 months.",{"count":347,"type":23},[523],"PHASE2","Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder affecting women of reproductive age, with a prevalence of 10 to 13%. PCOS is characterized by irregular menstrual cylcles\u002Fovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. For infertile patients seeking ovulation induction, letrozole is the drug of first choice. For PCOS patients not seeking pregnancy, there exists a variety of treatments to alleviate symptoms. It has been demonstrated that artemisinin derivatives can promote energy expenditures and insulin sensitivity by activating thermogenic adipocytes, thereby protecting against diet-induced obesity and metabolic disorders in rodents. Recently, we showed in a single arm pilot study including 19 PCOS-patients, that dihydroartemisinin ameliorated hyperandrogenemia reduced antral follicle count and normalized menstrual cycles. Based on these findings, we aim to evaluate the efficacy of dihydroartemisinin in women with PCOS in a placebo controlled randomized clinical trial. The primary outcome is return of regular menstrual cycles within 6 months after start of treatment, with antral follicle count and metabolic profile being secondary outcomes. The results will potentially impact the standard of care for patients diagnosed with PCOS.",[27],[91,527],"Dihydroartemisinin","2025-04-17",{"date":530,"type":39},"2025-04-20",{"date":532,"type":39},"2025-04-16",{"date":534,"type":23},"2026-12-31",{"name":536,"class":46},"Shanghai Zhongshan Hospital",4,{"id":539,"slug":540,"hasResults":11,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":59,"phases":547,"briefSummary":549,"conditions":550,"keywords":551,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":289},"100527112","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-pcos-100527112","NCT06143527","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome","Inclusion Criteria:\n\n• Ultrasound documented poly cystic ovary syndrome\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety\n* Continued drug abuse\n* Previous organ transplant\n* Hypersensitivity to sulfur\n* Inability to supply proper informed consent",{"count":546,"type":23},20,[548],"PHASE1","This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.",[27,91,29],[27,91,29,552,553,554,555],"Stem Cell","Stem Cells","Mesenchymal Stem Cells","Umbilical Cord Derived Mesenchymal Stem Cells","2025-04-04",{"date":558,"type":39},"2025-04-08",{"date":560,"type":39},"2023-11-16",{"date":562,"type":23},"2027-11-16",{"name":564,"class":46},"The Foundation for Orthopaedics and Regenerative Medicine",{"id":566,"slug":567,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":298,"enrollmentInfo":572,"targetDuration":4,"studyType":59,"phases":574,"briefSummary":575,"conditions":576,"keywords":577,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":584,"leadSponsor":586,"locationsCount":47},"100586224","app-impact-on-quality-of-life-and-symptoms-in-pcos-100586224","NCT06912594","App Impact on Quality of Life and Symptoms in PCOS","Pilot Study to Investigate the Influence of an App on the Quality of Life and Symptoms of Patients With Polycystic Ovary Syndrome","Inclusion Criteria:\n\n* Legal capacity\n* Resident in Germany\n* Female gender\n* Age ≥18 years up to 65 years\n* Diagnosed and medically confirmed Polycystic Ovary Syndrome (E28.2)\n* Ownership of a smartphone with a compatible iOS or Android version and the ability to operate it\n* Internet access and an email address for registration, app usage, and completing questionnaires\n* Willingness to complete questionnaires online\n* Motivation to use the app regularly\n* Sufficient knowledge of the German language\n\nExclusion Criteria:\n\n* Changes in hormone therapy within eight weeks prior to the start of the study and\u002For planned within the next 12 weeks\n* Changes in treatment with metformin within eight weeks prior to the start of the study and\u002For planned within the next 12 weeks\n* Current treatment with medications for obesity (e.g., liraglutide, orlistat)\n* Changes in treatment with anti-androgens (e.g., spironolactone, cyproterone acetate, flutamide) within eight weeks prior to the start of the study and\u002For planned within the next 12 weeks\n* Pregnancy or breastfeeding\n* Current hormonal fertility treatment\n* Changes in treatment with psychotropic medications within eight weeks prior to the start of the study and\u002For planned within the next 12 weeks\n* Current psychotherapeutic treatment\n* Previous or current access to the Endo-App or other digital health applications (DiGAs)\n* Current participation in other clinical studies\n* Current nutritional counseling according to §20 SGB V or nutritional therapy according to §43 SGB V, or participation in weight reduction programs",{"count":573,"type":23},220,[61],"This study investigates the influence of a PCOS app on the quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). The intervention group can use the app over the study period of twelve weeks in addition to care-as-usual (CAU). In the control group, this is compared with no use of the PCOS-App for a twelve-week period, that is, care-as-usual only\u002F continuation of the current treatment (waitlist design). The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 220 participants.",[27],[29,578,579],"Quality of Life","Digital Therapeutics","2025-04-02",{"date":582,"type":39},"2025-04-06",{"date":580,"type":23},{"date":585,"type":23},"2025-09",{"name":587,"class":109},"Endo Health GmbH"]