Comparison of the effect of treatment with metformin and metformin together with oral royal jelly on induction-ovulation cycles in infertile women with polycystic ovary syndrome.

Determining the effect of royal jelly on ovarian follicle size and maturation Determination of the effect of royal jelly on the thickness of the endometrium

clinical trial , parallel-group, double-blind, randomized clinical trial, phase one, on 110 infertile women with polycystic ovary syndrome. two groups by random allocation. randomly assigned to one of groups A or B before entering the study. After the visit and receiving the prescription, they are referred to the desired pharmacy and receive one of the packs A or B, which includes metformin + royal gel capsules, and the other pack includes metformin and placebo capsules. In this way, patients are not deprived of the main treatment and do not know about the complementary treatment.

Sabzevar University of Medical Sciences Polycystic patients referred to the infertility clinic who are also subjected to ultrasound in the clinic

first be diagnosed with polycystic ovary syndrome using the Rotterdam criteria. Also, they should have a normal hysterosalpingography and the spouse's spermogram should be normal, and they should not have undergone ovulation induction

. In the control group, metformin tablets 1500 mg + placebo capsules with the same color and shape as royal jelly are prescribed daily for two months, and in the experimental group, metformin tablets with the same dose and at the same time, plus royal gel with a dose of 800 mg are prescribed. It is given daily before breakfast. After taking the drugs for two months, both groups will be subjected to ovulation induction with Letrozole and CinalF,

Number of follicles, follicle size, endometrial thickness

In this research, the allocation of samples to each group is done in a simple random manner, so that after confirming the inclusion criteria, we place the first person in the intervention or control group with a simple randomization model of lion or line by tossing a coin. (line in the intervention group and milk in the control group) and after that they will be placed in the middle of the intervention and control groups until the number of samples in the two groups is completed.

The method of blinding in this study will be that before entering the study, eligible patients will be randomly assigned to one of groups A or B, and the demo graphic information of the desired group will be recorded in the questionnaire. After the visit and receiving the prescription, they are referred to the desired pharmacy and receive one of the packs A or B, which includes metformin + royal gel capsules, and the other pack includes metformin and placebo capsules. In this way, patients are not deprived of the main treatment and do not know about the complementary treatment. The researcher also does not know about the content of the pegs, and only in this research is the knowledgeable person a pharmaceutical consultant.

The results of the data will be published in the form of articles and the information of the participants will remain confidential.

The beginning of 1400 and the end of 1402

Accessible to the public

Fisher's chi-square and Mann-Whitney statistical tests and..

Can be published on official sites

After the defense in the faculty, it will be published as an article