The effect of Persian medicine product containing asparagus root (Asparagus officinalis L) on ovarian follicle growth and incidence of pregnancy in infertile women with polycystic ovarian syndrome (PCOS)

Determining the effect of Iranian medicine product containing asparagus root on ovarian follicle growth and pregnancy in infertile women with polycystic ovarian syndrome (PCOS)

Random and controlled clinical trial, three-blind with 50 samples

Infertile patients referred to the infertility center of Shahid Beheshti Hospital in Kashan who have the inclusion criteria of the study will be selected by the researcher, then the details of the study will be explained by him, then a questionnaire including demographic characteristics and disease information will be prepared. Patients are then randomly assigned to one of two treatment groups.

Inclusion criteria: Adult women, aged between 20 to 35, infertile women with polycystic ovarian syndrome, infertility of at least 1 year and up to 5 years / Exclusion criteria: Male factor infertility , infertility due to tubular cause, endometriosis, patients with liver, kidney, joint and rheumatic and metabolic disorders

Intervention: 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 Iranian medicine product containing asparagus root syrup twice a day, 30 cc each morning and evening during 2 ovulation stimulation cycles from the first to the fourteenth day of the menstrual cycle. Control: In addition to receiving letrozole (5 mg) daily from the third to the seventh day of the menstrual cycle, the control group will be treated with 30 cc placebo syrup in the morning and evening during 2 ovulation stimulation cycles from the first to the fourteenth day of the menstrual cycle.

Ovarian follicle size, numbers of dominant follicles, 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 50 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 25 times without replacement; To identify all the people belonging to the announced group. The remaining 25 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 50 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 50 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.

Data will be sent to researchers upon request.

After publication the results of study

Researchers

for systematic or meta-analysis study

ِDr Fatemeh Nojavan

E-mail correspondence with the principle researcher