To Evaluate Efficacy and Safety of Multiple Micronutrients Preparation in Women with Polycystic Ovary Syndrome or Subfertility

Meyer Organics Pvt Ltd Thane0 个研究点目标入组 104 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Young women of age between 18 to 38 yrs with PCOS [Presence of any two of the following parameters: (Roterdam criteria 2003)
•Oligomenorrhea and/or anovulation.
•Subjects with Hyperandrogenism. (clinical and/or biochemical) (Ferriman-Gallwey score >8; biological (LH/FSH ratio >2]
•Subfertile females
•Sexually active and male partner with potential of produce a child
•Polycystic ovaries with exclusion of other etiologies.
•Women with normal uterine cavity
•Subjects with Impaired Glucose Tolerance or Insulin Resistance.
•Normal physical activity confirmed with physical and clinical examination, and routine laboratory tests, including AST, ALT, hematology routine urinalysis and measurement of oral temperature and vital signs.

•Pregnant or lactating women.
•Subjects with presence of infertility factors other than anovulation
•Subjects with pelvic organic pathologies, presence of other pathologies such as non-classical congenital adrenal hyperplacia, cushingâ??s syndrome and androgen secreting tumors,
•Subjects with thyroid dysfunction, hyprolactenemia, androgen secreting neoplacia.
•Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and antiobesity drugs, or other hormonal drugs.
•Subjects taking vitamins & micronutrient supplementation at the time of screening.
•Subjects with any neoplastic, metabolic, and cardiovascular disorder or other concurrent medical illness (i.e. type 1 or type 2 diabetes, renal disease, and malabsorptive disorders, acute and chronic inflammations) confirmed based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.
•Subjects with known history of hypersensitivity to the study drugs.
•Alcoholic consumers and smokers

发起方

Meyer Organics Pvt Ltd Thane