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IRCT20130211012438N34 IRCT 2023-01-23 Kashan University of Medical Sciences The effects inofolic supplementation, probiotic and vitamin D in polycystic ovary syndrome women candidate for In Vitro fertilization The effect of inofolic supplementation in combination with probiotics and vitamin D on ovarian response and metabolic profiles in women with polycystic ovary syndrome candidate for In Vitro Fertilization 2023-02-20 anticipated 120 Complete https://irct.ir/trial/67098 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The people who entered the study based on the inclusion and exclusion criteria will be randomly assigned to one of the four control or intervention groups within each block using the random block method. The size of each block will be equal to four, eight or twelve samples, which will be applied to people based on a random permutation of treatments after completing each block. Blocks and permutations within each block will be created using the agricolae package in R software and using a specific seed, Blinding description: Coding and similar packaging will be used for blinding. Therefore, the physician, patient, researcher and statistical analyzer are blind to the content of the packages. At the end of the study and analysis of data, decoding will be done.Another person at the clinic, who is not involved in the trial and not aware of assignments, will assign numbered bottles of capsules to the participants .Placebos capsules are completely identical with supplements in terms of their appearance, color, shape, size, and packaging. 3 Condition 1: Polycystic ovary syndrome. Condition 2: Infertility. Intervention 1: Intervention group 1: Inofolic Sachet ; Inositol 2gr, twice a day(Teb mofid nikan,Alborz, Iran) plus probiotic Capsule;Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium langum, Bifidobacterium lactis (1.8 ×109 CFU/capsule), One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D Capsule; 4000 IU ,One capsule per day( Daana ,Tabriz ,Iran) for 8 weeks orally. Intervention 2: Intervention group 2: Inofolic Sachet ; Inositol 2gr, twice a day(Teb mofid nikan, Alborz, Iran) plus probiotic Capsule;Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium langum, Bifidobacterium lactis (1.8 ×109 CFU/capsule), One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D placebo (Daana ,Tabriz ,Iran), One capsule per day for 8 weeks orally. Intervention 3: Intervention group 3: Inofolic Sachet ; Inositol 2gr, twice a day(Teb mofid nikan ,Alborz,Tehran) plus Probiotic placebo ;starch, One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D Capsule; 4000 IU ,One capsule per day( Daana ,Tabriz ,Iran) for 8 weeks orally. Intervention 4: Control group: Inofolic Sachet; Inositol 2gr, twice a day(Teb mofid nikan ,Alborz, Iran) plus Probiotic placebo; starch ( Takgene Zist ,Tehran, Iran), One capsule per day plus Vitamin D placebo (Daana ,Tabriz,Iran), One capsule per day for 8 weeks orally. No - There is not a plan to make this available Justification or reason for not sharing IPD is Information is kept confidential.
public Mohsen Taghizadeh
School of Medicine, Qotbe Ravandi Boulevard, Kashan,Iran
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5533 3213 taghizadeh_m@kaums.ac.ir Kashan University of Medical Sciences scientific Mohsen Taghizadeh
School of Medicine, Qotbe Ravandi Boulevard, Kashan,Iran
kashan Iran (Islamic Republic of) 81151-87159 +98 31 5533 3213 taghizadeh_m@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Women with Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria In Vitro Fertilization (IVF) candidate Age 45-30 years No smoking Male reproductive health 30 years 45 years Female Uncontrolled thyroid disorder Diagnosis of severe depression E28.2 N97 Polycystic ovarian syndrome Female infertility Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Inofolic Sachet ; Inositol 2gr, twice a day(Teb mofid nikan,Alborz, Iran) plus probiotic Capsule;Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium langum, Bifidobacterium lactis (1.8 ×109 CFU/capsule), One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D Capsule; 4000 IU ,One capsule per day( Daana ,Tabriz ,Iran) for 8 weeks orally Intervention group 2: Inofolic Sachet ; Inositol 2gr, twice a day(Teb mofid nikan, Alborz, Iran) plus probiotic Capsule;Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium langum, Bifidobacterium lactis (1.8 ×109 CFU/capsule), One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D placebo (Daana ,Tabriz ,Iran), One capsule per day for 8 weeks orally Intervention group 3: Inofolic Sachet ; Inositol 2gr, twice a day(Teb mofid nikan ,Alborz,Tehran) plus Probiotic placebo ;starch, One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D Capsule; 4000 IU ,One capsule per day( Daana ,Tabriz ,Iran) for 8 weeks orally Control group: Inofolic Sachet; Inositol 2gr, twice a day(Teb mofid nikan ,Alborz, Iran) plus Probiotic placebo; starch ( Takgene Zist ,Tehran, Iran), One capsule per day plus Vitamin D placebo (Daana ,Tabriz,Iran), One capsule per day for 8 weeks orally Anti Mullerian Hormone (AMH). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA. High Sensitivity- C Reactive Protein (hs-CRP). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA. Beck score. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Beck questionnaire. Fasting plasma glucose. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Enzymatic Kits with BT-3000. Insulin. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA. HOMA-IR. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Calculated with standard formula. Nitric oxide. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry. Total Anti Oxidant (TAC). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry. Glutathion. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry. Malondialdehyde. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry. Peroxisome proliferator-activated receptor gamma (PPAR-γ ) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR. Low Density Lipoprotein Receptor (LDLR) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR. Tumour necrosis factor α (TNFα) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR. Interferon gamma (IFN-γ) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR. Vascular endothelial growth factor (VEGF) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR. Anxiety. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Beck questionnaire. Sleep Quality. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Ovarian response. Timepoint: 8 weeks after the start of the intervention. Method of measurement: Optical microscope. Kashan University of Medical Sciences Approved 2022-11-06 Ethics Committee of Medical and Dental Faculties of Kashan University of Medical Sciences Kashan University of Medical Sciences,Qotbe Ravandi Boulevard, Kashan,Phone number :03155542999 Kashan Isfehan Iran (Islamic Republic of)