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IRCT20210207050279N1 IRCT 2024-01-10 Iranian academic center for education culture and research Modification of Complications Caused by Polycystic Ovary Syndrome by Nano Curcumin Drug and HIIT Exercise in Women Undergoing ICSI Treatment Effects of High Intensity Interval Training(HIIT) with Nano Curcumin Supplementation on MDA,SOD,GPX,TAC, LH,FSH,TT and Oocytes Maturation , Embryos Quality in Patients with PCOs Undergoing ICSI treatment. a Randomized Placebo-Controlled Clinical Trial 2023-12-31 anticipated 40 Complete https://irct.ir/trial/74508 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 40 Beads are Placed in a Box, which are Numbered From 1 to 4. After Accepting Each Patient and After Obtaining Informed Consent, The Treating Physician Randomly Removes one of the Beads Inside the Box (without Seeing the Contents of the Box) and in this Way, People are Classified Into Different Groups, so that Numbers 1 belong to the HIIT Training Group, Numbers 2: Nano Curcumin Supplement, Numbers 3: HIIT and Curcumin Supplement, Numbers 4: Control Group, Blinding description: The Gynecologist was Fully Informed by the Project Manager about Nano Curcumin Drug and the Properties and Side Effects of the Drug. Patients were Placement in the Control and Treatment Group is the Responsibility of The Gynecologist. Patients Who Entered the Project with Full Consent, but Do not Know Whether They will be Placed in the Control or Treatment Group. 3 Polycystic ovary syndrome. Intervention 1: Intervention Group: Curcumin Nano Micelle Capsule (80 mg Daily for 12 Weeks) and Metformin (500 mg Daily for 12 weeks). Intervention 2: Intervention group: HIIT ٍExercise (Three Sessions Per Week) and Nanomicelle Curcumin (80 mg daily for 12 weeks) and Metformin (500 mg Daily for 12 Weeks). Intervention 3: Intervention group: HIIT Exercise (Three Sessions per Week) and Metformin (500 mg per Day for 12 Weeks). Intervention 4: Control group: Metformin, 500 mg Three Times a Day for 12 Weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet Known if There Will be a Plan to Make this Available
public Elham Asa
Unit 10, 3rd Floor, Razi Building, Razi Alley, Shahid Karimi Blvd
Qom Iran (Islamic Republic of) 3739164393 +98 25 3339 8378 asa.elham@gmail.com Iranian academic center for education culture and research scientific Elham Asa
Unit 10, 3rd Floor, Razi Building, Razi Alley, Shahid Karimi Blvd
ًQom Iran (Islamic Republic of) 3739164393 +98 25 3336 8378 asa.elham@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) Period Disorders Hirsutism Infertility Increased LH/FSH ratio Ultrasound View in the form of Enlarged Ovaries Having Numerous Follicles with a Size of 2-10 mm The Normality of Sperm Analysis Normal Thyroid Function No Endometriosis Normal Prolactin Level Normal Hysterosalpingography 20 years 35 years Female Infertility Factors other than Ovulation Male factor infertility Pelvic Organ Injuries Congenital Adrenal Hyperplasia Thyroid Dysfunction Cushing Syndrome Severe Liver or Kidney Diseases Active Gastric Ulcer Drug Sensitivity Intolerance of Exercise E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention Group: Curcumin Nano Micelle Capsule (80 mg Daily for 12 Weeks) and Metformin (500 mg Daily for 12 weeks) Intervention group: HIIT ٍExercise (Three Sessions Per Week) and Nanomicelle Curcumin (80 mg daily for 12 weeks) and Metformin (500 mg Daily for 12 Weeks) Intervention group: HIIT Exercise (Three Sessions per Week) and Metformin (500 mg per Day for 12 Weeks) Control group: Metformin, 500 mg Three Times a Day for 12 Weeks Regulation of Sex Hormones. Timepoint: Before Taking the Drug and 12 weeks After Starting to Take the Drug. Method of measurement: Elisa Kit. Stress Oxidative Level. Timepoint: Before Taking the Drug and 12 weeks After Starting to Take the Drug. Method of measurement: Laboratory Kits. Oocyte and Embryo Quality. Timepoint: After Completing the Intervention. Method of measurement: Shape and Morphology. Pregnancy Rate. Timepoint: 2 Weeks After Embryo Transfer. Method of measurement: Laboratory kits. Iranian academic center for education culture and research Approved 2023-11-27 Ethics committee of Qom University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran Tehran Tehran Iran (Islamic Republic of)