[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426738":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":35,"locations":41,"responsibleParty":56,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":80,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Group: Women with Polycystic Ovary Syndrome",null,"Woen diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Criteria (requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen. 2. Oligo or anovulation. 3. Polycystic ovaries on ultrasound - over 12 follicles, 2-9 mm or increased ovarian volume),who haven't started any treatment",[13,14,15],"Other: Dietary recommendations","Drug: Oral contraceptive pills","Drug: Metformin",{"label":17,"type":10,"description":10,"interventionNames":10},"Cohort Group: Women without Polycystic Ovary Syndrome",[19,26,31],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"OTHER","Dietary recommendations","Fruit, vegetables, legumes (e.g. lentils and beans), nuts and whole grains (e.g. unprocessed maize, millet, oats, wheat and brown rice).\n\nAt least 400 g (i.e. five portions) of fruit and vegetables per day excluding potatoes, sweet potatoes, cassava and other starchy roots.\n\nLess than 10% of total energy intake from free sugars Less than 30% of total energy intake from fats. Unsaturated fats (found in fish, avocado and nuts, and in sunflower, soybean, canola and olive oils) are preferable to saturated fats.\n\nLess than 5 g of salt (equivalent to about one teaspoon) per day.",[9],[25],"World Health Organisation (WHO) recommendations",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"DRUG","Oral contraceptive pills","Hormonal treatment",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Metformin","Insulin resistance treatment",[9],[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Aya Mohr-Sasson, M.D","CONTACT","0523692906","mohraya@gmail.com",[42],{"facility":5,"status":10,"city":43,"state":10,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Ramat Gan","52621","Israel","IL",{"type":48,"coordinates":49},"Point",[50,51],34.81065,32.08227,{"lat":51,"lon":50},[54],{"name":55,"role":38,"phone":39,"phoneExt":10,"email":40},"Aya Sasson",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Dr. Aya Mohr-Sasson","Principal Investigator","100426738","microbiome-and-polycystic-ovaries-100426738",false,"NCT04836910","Microbiome and Polycystic Ovaries","The Change in Microbiome Following Treatment of Women With Polycystic Ovaries","Inclusion Criteria:\n\nStudy group: Untreated women diagnosed with PCOS that are planned for intervention.\n\nControl group: Women without PCOS visiting the gynecologic outpatient's clinics.\n\nExclusion Criteria:\n\n1. Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor).\n2. Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics\u002F probiotics, hormonal, vaginal or laxative medicine (in the previous week).\n\n4\\. Vaginitis\u002F Pelvic Inflammatory Disease (PID)","FEMALE","18 Years","42 Years",{"count":71,"type":72},40,"ESTIMATED","OBSERVATIONAL","Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS .\n\nTherefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.",[76,77],"Polycystic Ovary Syndrome","Microbial Colonization",[79],"polycystic ovaries, microbiome","NOT_YET_RECRUITING","2024-11-12",{"date":83,"type":84},"2024-11-14","ACTUAL",{"date":86,"type":72},"2025-09-01",{"date":88,"type":72},"2027-03-30",{"name":5,"class":6},1]