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

Determining the effect of "Iranian medicinal product made from silk" on the occurrence of pregnancy in infertile women with polycystic ovary syndrome.

A randomized clinical trial with a control group, with parallel groups, and thriple blind with 58 samples, the Rand function of Excel software, was used for randomization.

Infertile patients referred to Reihaneh Qom Infertility Center who meet the entry criteria of the study are selected by the researcher, then the details of the study will be explained by the researcher. Then the patients are randomly assigned to one of the two treatment groups.

Inclusion criteria: adult women, aged between 20 and 40, infertile women with polycystic ovary syndrome, infertility for at least 1 year, and a maximum of 5 years. Exclusion criteria: infertility due to male factor, infertility due to tubal causes, endometriosis, patients with liver, kidney, joint, rheumatic, and metabolic disorders

Intervention group: In addition to receiving letrozole (5 mg) daily from the third to the seventh day of the menstrual cycle, the intervention group will be treated with an Iranian medicine product made from silk 3 times a day, 10 cc each time the morning and evening during 3 cycles of ovulation stimulation from days first to 14. It will be from the first to the fourteenth of the menstrual cycle. Control group: In addition to receiving letrozole (5 mg) daily from the third to the seventh day of the menstrual cycle, they will be treated with placebo syrup 10 cc 3 times a day during 3 ovulation stimulation cycles from the first to the fourteenth day of the menstrual cycle.

Ovarian follicle size, dominant follicle number, endometrial thickness and pattern, chemical fertility rate, clinical pregnancy rate

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

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.