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IRCT20230712058752N1 IRCT 2023-07-18 Mashhad University of Medical Sciences Investigating the effect of jujube hydroalcoholic extract on the pregnancy outcomes of infertile polycystic ovary syndrome patients Investigating the effect of jujube hydroalcoholic extract on the pregnancy outcomes of infertile polycystic ovary syndrome patients s undergoing ovulation induction and comparing it with myoinositol and metformin. 2023-07-12 anticipated 196 Complete https://irct.ir/trial/71240 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done using Sealedenvelope.com website. Blocks of 4 or 8 will be used to create a random sequence in the present study, Blinding description: In the groups receiving tablets, sachets and in the groups receiving sachets, placebo tablets will be used. 1-2 polycystic ovary syndrome. Intervention 1: the first Intervention group:: Jujube, in the form of jujube hydroalcoholic extract in the amount of one 10 gram sachet per day, dissolved in 100 cc of cooled boiled water and consumed by patients for 12 weeks. This sachet is prepared from jujube hydroalcoholic extract in Mashhad Faculty of Medicine, Department of Pharmacology. Intervention 2: the second intervention group: Metformin, taking one Glucophage 500 mg metformin tablet after lunch for 12 weeks. Intervention 3: the third intervention group: Myoinositol, in the form of one inofolic sachet daily for 12 weeks. Intervention 4: Control group: Placebo, in tablet form in the sachet receiving groups, and in sachet form in the pill receiving groups, one daily 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 There is no further information
public Faezeh Mashhadi
Park square, mashhad university of medical sciences
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3841 2081 mashhadif4001@mums.ac.ir Mashhad University of Medical Sciences scientific Faezeh Mashhadi
park square, mashhad university of medical sciences
Mashhad Iran (Islamic Republic of) ١٣٩۴۴ ٩١٣٨٨ +98 51 3841 2081 mashhadif4001@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Women with PCOS according to the Rotterdam criteria age range between18-45 years Willing to cooperate in the study Trying to get pregnant for more than a year No history of liver and kidney disease No other metabolic diseases No history of hyperprolactinemia, Cushing's, hypothyroidism, congenital adrenal hyperplasia Absence of various allergies Not using contraceptive and hormonal pills during the 3 months before the study 18 years 45 years Female other metabolic disease thyroid disorders OCP and hormonal drugs before intervention history of allergy history of cancer alcohol or drugs abuse infertility due to disease another than PCOS N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo the first Intervention group:: Jujube, in the form of jujube hydroalcoholic extract in the amount of one 10 gram sachet per day, dissolved in 100 cc of cooled boiled water and consumed by patients for 12 weeks. This sachet is prepared from jujube hydroalcoholic extract in Mashhad Faculty of Medicine, Department of Pharmacology the second intervention group: Metformin, taking one Glucophage 500 mg metformin tablet after lunch for 12 weeks the third intervention group: Myoinositol, in the form of one inofolic sachet daily for 12 weeks Control group: Placebo, in tablet form in the sachet receiving groups, and in sachet form in the pill receiving groups, one daily for 12 weeks. Biochemical pregnancy. Timepoint: after intervention. Method of measurement: blood sample. Change in PCOS morphology in sonography. Timepoint: after intervention. Method of measurement: ultrasound sonography. Mashhad University of Medical Sciences Approved 2023-06-20 Ethics committee of Mashhad Medical University of Medical Sciences, faculty of medicine Mashhad, 91778 99191Razavi Khorasan Province Mashhad Razavi Khorasan Iran (Islamic Republic of)