Comparison of the effect of sitagliptin and metformin on oocyte and embryo quality, number of retrieved and fertilized oocyte and embryo the Polycystic ovary syndrome (PCOS) insulin-resistant women undergoing In vitro fertilization (IVF)

Comparison of the effect of Sitagliptin and Metformin on oocyte and embryo quality, number of retrieved and fertilized oocyte and embryo the PCO insulin-resistant women undergoing IVF

Clinical trial, with parallel groups, double-blind, phase three, randomized, where 76 patients will be randomly assigned to two groups of 38 people with the size of blocks of 8.

The studied population are women aged 18-40 referring to the Fatima Zahra Infertility Research Center of Babol. Patients are randomly divided into two intervention groups by block method. Intervention group 1: PCO women treated with sitagliptin (Elixir Pharmaceutical Company) 100 mg three times a day Intervention group 2: PCO women treated with Metformin (Zagros Daru Company) 500 mg 3 times a day

Diagnosis of PCOS based on Rotterdam criteria؛ Age 18 to 40 years؛ BMI≥20؛ Insulin resistant؛ IVF candidate؛ Not taking drugs that are effective on the activity of two drugs at this time in the last 3 months؛ Not taking weight-loss drugs or having any slimming diet or regular aerobic exercise in the last 3 months؛ Not receiving assisted reproductive treatments in the last 3 months Exclusion Criteria: Getting pregnant during the study؛ The patient's lack of consent to enter or the patient's lack of cooperation in taking the medicine؛ smoking

Intervention group 1: PCO women treated with sitagliptin (Elixir Pharmaceutical Company) 100 mg three times a day Intervention group 2: PCO women treated with Metformin (Zagros Daru Company) 500 mg 3 times a day

oocyte and embryo quality (average number of recovered, fertilized oocyte and embryos formed with excellent quality)

Due to the corona pandemic and lack of referrals of sufficient number of patients. It was not possible to realize the expected sample size. Therefore, according to the opinion of the statistical consultant, the sample size has been changed.

Patients were randomly assigned to two groups of 38 using a block of 8 and a ratio of 1:1. In order to generate the allocation sequence, the free website com.randomization.www will be used. The obtained sequence will be written on separate sheets and will be placed in closed envelopes and will be provided to the main researcher to conduct the study.

Medicines are in capsule form. For the purpose of blinding, the capsules containing sitagliptin are chosen to be completely identical to metformin capsules so that they are completely similar in terms of smell, color and shape. The capsules containing these drugs are placed in cans of the same shape and size, and then a 3-digit code is written on each can. After the patient enters the study, one of these cans is assigned to the patient and the code on the can is on the patient file (study checklist) is written. Opening the codes will be done after completing the study.