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IRCT20221009056122N1 IRCT 2022-11-01 Ghoum University of Medical Sciences To evaluate the effect of a Persian medicine product, containing silk, on the incidence of pregnancy in infertile women with polycystic ovary syndrom To evaluate the effect of a Persian medicine product, containing silk, on the incidence of pregnancy in infertile women with polycystic ovary syndrome-A Randomized clinical trial 2022-11-22 anticipated 58 Complete https://irct.ir/trial/66347 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocations will be made by simple randomization of patients available at the infertility treatment center. In the first step, the groups are written in the form of groups A and B. Then, to assign the intervention group and the control group to group A or B, a lottery is drawn between the two groups. In the second step, numbers from 1 to 58 are written on paper so that they are not visible and thrown into a container. In the third stage, a person announces that patients choose the intervention or control group, then picks up a number from the container and reads it and writes notes in the group he or she announced. This is repeated 29 times without replacement; To identify all the people belonging to the announced group. The remaining 29 numbers are then assigned to the second group. Finally, at the time of each patient's visit to the infertility center, each patient selects a number from a container containing 58 numbers from 1 to 50 and gives it to the researcher, then the researcher selects the patient in the relevant group according to the selected number. This is done up to 58 times to complete the groups, Blinding description: The present study is a three-blind study. In this study, the patient, the facilitator (physician) and the statistical consultant will not know the content of the syrup and blinding will be done for them. Only the traditional medicine referee who is responsible for preparing the syrup of Iranian traditional medicine and placebo syrup will know the content of medicinal syrups. Individuals who have the inclusion criteria, if they wish to participate in the study, after obtaining informed written consent, take the syrup of traditional Iranian medicine and placebo, which are in the same package and completely similar in terms of color and aroma randomly. The blinding method will be performed in such a way that a special code will be considered for each syrup and it will be recorded on the syrup label. Only pharmacist consultant will know about drug codes. Medications will be provided to the physician, project manager, and patient. The code of each syrup for each patient will be inserted in the file and the patient checklist by the executor. At the end of the study, for statistical analysis, information and patient checklist form will be provided to the statistical consultant, and after analyzing the data, the syrup code will be provided to the executor and statistical consultant by the pharmacist for final analysis. 3 Infertility in women with polycystic ovary syndrome. Intervention 1: Intervention group: the intervention group, in addition to the common ovulation-stimulating drug, letrozole 2.5 mg twice (5 mg) once a day from the third to the seventh day of the menstrual cycle (and if necessary HMG and Sinal F), silk worm coccon syrup made by Qom School of Traditional Medicine during 3 ovulation stimulation cycles from the first to the fourteenth menstrual cycle will be given three times a day, 10 cc each morning and evening. Intervention 2: Control group: the control group, in addition to the common ovulation-stimulating drug, letrozole 2.5 mg twice (5 mg) once a day from the third to the seventh day of the menstrual cycle (and if necessary HMG and Sinal F), placebo syrup made by Qom School of Traditional Medicine during 3 ovulation stimulation cycles from the first to the fourteenth menstrual cycle will be given three times a day, 100 cc each morning and evening. 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 Immunity
public Batoul Khayatzadeh
15 Khordad Blvd., next to Koche 44, Qom School of Traditional Medicine
Qom Iran (Islamic Republic of) 3714848350 +98 25 3776 4073 bkhaiatzadeh@muq.ac.ir Ghoum University of Medical Sciences scientific Majid asghari
15 Khordad Blvd., next to Koche 44, Qom School of Traditional Medicine
QOM Iran (Islamic Republic of) 3714848350 +98 25 3776 4073 Asghari.rall@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Infertile women suffering from polycystic ovary syndrome referred to Rehane Infertility Center, Nekoui Hospital, Qom. Informed consent to enter the plan The period of infertility is at least 1 year and at most 5 years BMI less than 30 kg/m2 20 years 40 years Female Male factor Infertility Tubular infertility other types of ovarian cysts except for PCO Endometriosis Premature ovarian failure (POF) and decreased ovarian reserve (DOR) Underlying and systemic disease and malignancy Breast diseases such as breast cysts Liver, kidney, joint and rheumatic disorders Other diseases including metabolic diseases such as diabetes and endocrine disorders including uncontrolled hypothyroidism, hyperprolactinemia, and Cushing's disease Breast diseases such as breast cysts Liver, kidney, joint and rheumatic disorders Other diseases including metabolic diseases such as diabetes and endocrine disorders including uncontrolled hypothyroidism, hyperprolactinemia, and Cushing's disease Other diseases include metabolic diseases such as diabetes and endocrine disorders including uncontrolled hypothyroidism, hyperprolactinemia, and Cushing's disease N97.0 Female infertility associated with anovulation Treatment - Drugs Placebo Intervention group: the intervention group, in addition to the common ovulation-stimulating drug, letrozole 2.5 mg twice (5 mg) once a day from the third to the seventh day of the menstrual cycle (and if necessary HMG and Sinal F), silk worm coccon syrup made by Qom School of Traditional Medicine during 3 ovulation stimulation cycles from the first to the fourteenth menstrual cycle will be given three times a day, 10 cc each morning and evening. Control group: the control group, in addition to the common ovulation-stimulating drug, letrozole 2.5 mg twice (5 mg) once a day from the third to the seventh day of the menstrual cycle (and if necessary HMG and Sinal F), placebo syrup made by Qom School of Traditional Medicine during 3 ovulation stimulation cycles from the first to the fourteenth menstrual cycle will be given three times a day, 100 cc each morning and evening. Chemical pregnancy. Timepoint: After the first delay in menstruation, the fourth week of the menstruation cycle. Method of measurement: Serum Β-hCG meausurment. Clinical pregnancy. Timepoint: After a positive serum Β-hCG test, the fifth to sixth week of the menstruation cycle. Method of measurement: Observing fetal heart rate on ultrasound. The level of anxiety. Timepoint: The beginning and end of the intervention. Method of measurement: Anxiety score in Beck's questionnaire. Ghoum University of Medical Sciences Approved 2022-07-04 Research Ethics Committee of Qom University of Medical Sciences No. 83, Shahid Lotfi Niasar (Alley No. 4), University Jihad Alley, Saffashahr St. Qom Ghoum Iran (Islamic Republic of)