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IRCT20220803055607N1 IRCT 2022-08-04 Babol University of Medical Sciences The effect of sitagliptin and metformin on the quality of oocyte and embryos, the number of retrieved oocyte 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) 2022-08-13 anticipated 76 Complete https://irct.ir/trial/65118 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: Intervention group 1: PCO women treated with sitagliptin (Elixir Pharmaceutical Company) 100 mg three times a day. Intervention 2: Intervention group: PCO women treated with Metformin (Zagros Daru Company) 500 mg 3 times a day. 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 No more information
public Sedigheh Esmaeilzadeh
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 4713566547 +98 11 3233 8301 s.esmaeilzadeh@mubabol.ac.ir Babol University of Medical Sciences scientific Sedigheh Esmaeilzadeh
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 4713566547 +98 11 3233 8301 s.esmaeilzadeh@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Polycystic ovary syndrome (PCOS) based on Rotterdam criteria Age 18 to 40 years BMI≥20 Insulin resistant In vitro fertilization (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 18 years 40 years Female 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 E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Intervention group 1: PCO women treated with sitagliptin (Elixir Pharmaceutical Company) 100 mg three times a day Intervention group: PCO women treated with Metformin (Zagros Daru Company) 500 mg 3 times a day Oocyte and embryo quality. Timepoint: Two months after the start of the intervention. Method of measurement: The average number of retrieved oocyte, fertilized and formed embryos with excellent quality. Babol University of Medical Sciences Approved 2022-07-11 Ethics Committee of Babol University of Medical Siences Babol University of Medical Sciences, Gangafrooz Street, Daneshgah Square, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)