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IRCT20200831048569N1 IRCT 2020-10-29 Gonabad University of Medical Sciences The effect of Vitagnos tablets on the function of polycystic ovaries The effect of Vitagnus tablets on follicle number and size, endometrial thickness and fertility in infertile women with polycystic ovary syndrome 2020-11-21 anticipated 60 Complete https://irct.ir/trial/51494 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For sampling, first each of the eligible individuals is selected to enter the study and then the samples will be placed in each of the two groups (intervention) A or (control) B according to the available method based on quadruple block and random allocation. 4 blocks will be used for sampling (AABB, ABAB, BBAA, BABA, ABBA, BAAB), Blinding description: In this study, each questionnaire and medication package will be identified by the letters A (intervention group) and B (control group). The researcher, clinical caregiver (gynecologist) and the data analyst are blind to the type of intervention provided to each participant so that they do not know which questionnaire and medication package belong to which group. The only informed person is the midwife working at the sampling site. This person is fixed until the end of the study and his only role in the study is randomization. After explaining the research to the research units and obtaining informed written consent based on random allocation, they will be placed in two groups of intervention and control. 4 blocks will be used for sampling (AABB, ABAB, BBAA, BABA, ABBA, BAAB). 3 polycystic ovary syndrome. Intervention 1: Intervention group: Control group: From the beginning of the monthly cycle, they take 1 mg of folic acid tablets and one empty capsule (placebo) daily. The use of this pill and placebo will continue for two months, ie until the end of the next cycle. In the second menstrual cycle, the standard 2.5 mg letrozole drug is used daily for 5 to 5 nights from the 5th menstrual period. Intervention 2: Intervention group: Intervention group: Two Vitagnos tablets produced by Dineh Pharmaceutical Company (each tablet containing 20 mg of Vitagnos plant extract) in a capsule for two months from the first day of the menstrual cycle will be taken daily. This pill is available in all pharmacies and is licensed by the Food and Drug Administration. Simultaneously with the use of Vitagnos, 1 mg of folic acid will also be used by members of this group. Also, in this group, from the fifth day of the second cycle, like the control group, they will receive the standard treatment of letrozole for five nights. 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 more information.
public Vahideh Behmard
22 Street., Shahid Deljoo Ave., Abu Nasr Blvd
Shiraz Iran (Islamic Republic of) 7147681564 +98 71 3731 7895 vahideh.behmard@gmail.com Gonabad University of Medical Sciences scientific Roghaieh Rahmany Bilandi
Asian roadside
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 roghaiehrahmany@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Age 18 to 35 years Having written consent to participate in the study Infertility is known to cause polycystic ovary syndrome and rule out other causes of infertility Ultrasound-confirmed polycystic ovaries along with another Rotterdam criteria No other androgenic disorders such as adrenal hyperplasia or androgen-producing tumor Manifestations of hyperandrogenism (high testosterone) No diseases such as: hypothyroidism or hyperthyroidism, hyperprolactinemia, kidney, heart, liver, bone diseases, pituitary tumor, cancer and diabetes Do not take infertility drugs or any other hormonal drugs in the last three months Body mass index 18 to 35 Hypersensitivity to food and drugs such as lactose, letrozole and vitagnus 18 years 35 years Female Breastfeeding Smoking and drugse Stressful events in the last three months Previous surgery on one or both ovaries Taking haloperidol E28.2 Polycystic ovarian syndrome Placebo Treatment - Drugs Intervention group: Control group: From the beginning of the monthly cycle, they take 1 mg of folic acid tablets and one empty capsule (placebo) daily. The use of this pill and placebo will continue for two months, ie until the end of the next cycle. In the second menstrual cycle, the standard 2.5 mg letrozole drug is used daily for 5 to 5 nights from the 5th menstrual period. Intervention group: Intervention group: Two Vitagnos tablets produced by Dineh Pharmaceutical Company (each tablet containing 20 mg of Vitagnos plant extract) in a capsule for two months from the first day of the menstrual cycle will be taken daily. This pill is available in all pharmacies and is licensed by the Food and Drug Administration. Simultaneously with the use of Vitagnos, 1 mg of folic acid will also be used by members of this group. Also, in this group, from the fifth day of the second cycle, like the control group, they will receive the standard treatment of letrozole for five nights. Number of follicles. Timepoint: Before the intervention and 1/5 month after the intervention. Method of measurement: Sonography. Follicle size. Timepoint: Before the intervention and 1/5 month after the intervention. Method of measurement: Sonography. Endometrial thickness. Timepoint: Before the intervention and 1/5 month after the intervention. Method of measurement: Sonography. Fertility rate. Timepoint: Before intervention and 2 months after intervention. Method of measurement: BHCG test. Improve ovarian function. Timepoint: After the intervention. Method of measurement: sonography. Side effects. Timepoint: During and after the intervention. Method of measurement: check list. Gonabad University of Medical Sciences Approved 2020-10-20 Ethics Committee of Gonabad University of Medical Sciences Asian roadside Gonabad Razavi Khorasan Iran (Islamic Republic of)