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IRCT20220308054221N1 IRCT 2022-09-20 Ilam University of Medical Sciences The effect of inofolic powder on fertility in women with polycystic ovary syndrom The effect of inofolic powder on fertility in women with polycystic ovary syndrome referred to the gynecology clinic 2022-09-20 anticipated 100 Complete https://irct.ir/trial/62422 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, due to the lack of access to patients and the lack of a database of patients with polycystic ovaries, it is not possible to select a sample randomly, therefore, within 3 months of attending the women's clinic and meeting the entry and exit criteria, as well as obtaining The satisfaction of the clients with the diagnosis of polycystic ovary samples is collected. Therefore, the selection of the sample at this stage will continue until the completion of the sample volume. Then we randomly assign one patient to the control group and one patient to the intervention group. Patients will not be aware of the assigned group, but they will be aware that they have entered a study and will sign a written consent form. Therefore, the allocation of the sample to the control and intervention groups will be completely random. 2-3 Polycystic ovary syndrome. Intervention 1: case group: under treatment with 500 mg Metformin tablets with the brand name Glucophage twice a day and 5 mg Progesterone tablets with the brand name Medrofem twice a day, both pills on days 15 to 25 of the ovarian cycle and also Lo. Li. Pharma brand Inofolic powder is available in the form of two sachets per day throughout the monthfem are taken twice a day. Intervention 2: Control group: treated with metformin and progesterone on days 15 to 25 of the ovarian cycle. 500 mg metformin tablets with the brand name Glucophage are taken twice a day and 5 mg progesterone tablets with the brand name Medrofem are taken twice a day. 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 Mohamad Ehsan Mozafari
Ilam University of Medical Sciences, Pajuhesh Boulevard, Banganjab
Ilam Iran (Islamic Republic of) 6939177143 +98 84 3222 7134 ehsanmozafari75@gmail.com Ilam University of Medical Sciences scientific Mohamad Ehsan Mozafari
Ilam University of Medical Sciences, Pajuhesh Boulevard, Banganjab
Ilam Iran (Islamic Republic of) 6939177143 +98 84 3222 7134 ehsanmozafari75@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Women who have a proven history of polycystic ovary syndrome, tests, and ultrasound Clinical signs such as oligomenorrhea, irregular menstrual cycle and androgen-induced symptoms 15 years 50 years Female History of ovarian surgery in the last three months use of antiepileptic drugs and glucocorticoids congenital adrenal hyperplasia hypothyroidism, hyperthyroidism ICD-10 Cha ICD-10 Chapter XV: Pregnancy, childbirth and the puerperium Treatment - Drugs Treatment - Drugs case group: under treatment with 500 mg Metformin tablets with the brand name Glucophage twice a day and 5 mg Progesterone tablets with the brand name Medrofem twice a day, both pills on days 15 to 25 of the ovarian cycle and also Lo. Li. Pharma brand Inofolic powder is available in the form of two sachets per day throughout the monthfem are taken twice a day. Control group: treated with metformin and progesterone on days 15 to 25 of the ovarian cycle. 500 mg metformin tablets with the brand name Glucophage are taken twice a day and 5 mg progesterone tablets with the brand name Medrofem are taken twice a day. Percentage of infertile women who have had a positive pregnancy. Timepoint: Positive fertility in the first month or the second month or the third month after starting to use inofolic powder. Method of measurement: Positive B-hcg test and ultrasound. Increase the number and size of follicles. Timepoint: The first month, the second month and the third month after the start of inofolic powder. Method of measurement: sonography. Ilam University of Medical Sciences Approved 2022-05-17 Ethics Committee of Ilam University of Medical Sciences Ilam University of Medical Sciences, Pajuhesh Boulevard, Banganjab Ilam Ilam Iran (Islamic Republic of)