[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anovulatory-infertility\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anovulatory-infertility":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100519576","phase-1-efficacy-of-injectable-vitamin-d-supplementation-in-females-with-polycystic-ovary-syndrome-100519576",false,"NCT06045351","Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome","Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design","Inclusion Criteria:\n\n* Recently diagnosed PCOS with presence of at least 2 of these 3 elements: clinical or biochemical signs of hyperandrogenism, chronic anovulation and polycystic ovaries (1) (from reports of available routine TVS), with VDD serum levels VD \\\u003C20 ng\u002Fml(10), age range 18- 45 years, from all ethnic background will be included.\n\nExclusion Criteria:\n\n* : Exclusion of subjects will be done by the Co-Principal Investigators (Co-PI) after history, examination and complete evaluation in the respective clinics. All female subjects meeting any of the following criteria will be excluded from the study\n\n  * Pregnancy\n  * Hypercalcemia (plasma calcium concentrations\\> 2.65 mmol\u002FL)\n  * Tuberculosis or other granulomatous disorders\n  * Chronic liver disease or alanine transaminase (ALT) level 3 times higher than the normal limit, chronic\n  * Kidney disease or serum creatinine \\>2.0 mg\u002FdL,\n  * Drug Therapies: VD replacement ; participants who had received VD injection in the last 3 months prior to recruitment in the study, oral contraceptives, hormonal replacement therapy, glucocorticoids, calcium supplementation, insulin-sensitizing drugs (incretin mimetic drugs, thiazolidinedione, sulfonylurea), lipid-lowering drugs or other drugs affecting insulin sensitivity or serum androgens (e.g., niacin, corticosteroids, beta-blockers, calcium channel blockers, thiazide diuretics), anti-epileptics, anti-retroviral, cholestyramine, anti-fungal, statins, H2 blockers, immunosuppressant, chemotherapeutic agents, antimicrobials (Rifampicin, Isoniazid, Hydroxychloroquine) or any other drug modifying lipid metabolism in the previous 3 months prior to study\n  * Suffering from congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, type 2 Diabetes Mellitus, renal, hepatic or thyroid disorders, hyperparathyroidism, malabsorption syndromes, Chronic Kidney Disease, Hepatic failure, cystic fibrosis, vaginal bleeding of unknown etiology or \u002Fand suffering from COVID-19 (within 3 months).",true,"FEMALE","18 Years","45 Years",{"count":21,"type":22},142,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by \"the presence of any two out of three criteria: oligo and\u002For anovulation, excess androgen activity and\u002For polycystic ovarian morphology on ultrasound\". Considering role of vitamin D (VD) (3, 4) and high prevalence (58%) of deficiency in PCOS of Pakistan. Researchers hypothesized that its correction would improve response to standard PCOS treatment. The objective is to compare PCOS parameters in intervention group (Group A) receiving VD supplementation and then PCOS care with control group (Group B) receiving standard PCOS care and then VD supplementation. A randomized open label trial: delayed-start design will be conducted on VD deficient PCOS females VD \\\u003C 20ng\u002Fml ; Group A will receive VD injections 600,000 I.U I\u002FM once with 1 gram calcium supplement daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks. PCOS females in Group B will receive standard PCOS care (same) with addition of VD and calcium supplementation after 12 weeks till study end point. Study outcomes will be comparison of i) hyperandrogenism by Free Androgen Index \\[Total Testosterone, Steroid Hormone Binding Globulin ii) insulin Resistance by HOMA-IR (serum Insulin, Fasting Blood Glucose) and iii) oxidative stress by Total Antioxidant Capacity after 24-weeks in these Groups'd levels after supplementation will be assessed for confirmation of correction and calcium and albumin levels for detection of hypercalcemia. Results of this study will inform the clinicians to add VD before or after the standard PCOS care for rectification of endocrine and metabolic derangements as a cost-effective treatment and prevention strategy in these females.",[28],"Anovulatory Infertility",[30,31,32,33],"Poly cystic Ovarian Syndrome","randomized open label trial; delayed-start design","vitamin D","Pakistan","RECRUITING","2025-02-17",{"date":37,"type":38},"2025-02-18","ACTUAL",{"date":40,"type":38},"2024-01-01",{"date":42,"type":22},"2026-12-31",{"name":44,"class":45},"Aga Khan University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":46},"100356129","phase-2-autologous-prp-intra-ovarian-infusion-to-restore-ovarian-function-in-menopausal-women-100356129","NCT03916978","Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women","Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women","PRP","Inclusion Criteria:\n\n* Age between 45-55 years old\n* Amenorrhea for at least 12 months\n* Discontinuation of any complementary\u002Fadjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.\n* Willing to comply with study requirements\n\nExclusion Criteria:\n\n* Any pathological disorder related to reproductive system anatomy\n* Previous POI diagnosis\n* Abnormal karyotype\n* Endometriosis\n* Adenomyosis\n* Fibroids and adhesions\n* Infections in reproductive system\n* Current or previous diagnosis of reproductive system cancer\n* History of familiar cancer in reproductive system\n* Severe male factor infertility\n* Prior referral for PGT\n* Ovarian inaccessibility\n* Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)\n* BMI\\>30 kg\u002Fm2 or BMI\\\u003C18.5 kg\u002Fm2\n* Systematic autoimmune disorders","55 Years",{"count":57,"type":22},100,[59,60],"PHASE2","PHASE3","Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.",[63,28,64,65],"Infertility, Female","Menopause","Amenorrhea",[67,68],"Ovarian rejuvenation","Ovarian reactivation; ovulation","2024-12-20",{"date":71,"type":38},"2024-12-27",{"date":73,"type":38},"2019-05-21",{"date":75,"type":22},"2026-07-30",{"name":77,"class":45},"Genesis Athens Clinic"]