]>
IRCT20240128060827N1 IRCT 2024-02-11 Kashan University of Medical Sciences Comparison the Effect of Sitagliptin and Inositol on the Fertility Treatment in Polycystic Ovarian Syndrome Comparison of the effect of Sitagliptin and Inositol on the Oocyte and Embryo Quality in Poly Cystic Ovarian Syndrome (PCOS) Patients Undergoing Intra Cytoplasmic Sperm Injection (ICSI) 2024-04-02 anticipated 70 Complete https://irct.ir/trial/75219 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the Drug Package of Sitagliptin and Inofolic was Coded with the Letter A and the Drug Package of Inofolic with the Letter B, and then using the Website www.sealdenvelope.com/simple-randomiser/v1/lists, the Randomization List was Selected by Selecting a Sample Size of 70. And it is Prepared by Balanced Quadruple Blocking Method. Then, through the obtained Randomization list, the People Included in the study will be Assigned to one of the two groups A and B. For example, suppose that in the first quartet block, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples will be assigned to group B, and it will continue in this way until the last sample, Blinding description: A person who has no Role in this Trial and is not Aware of the Random Allocation will Allocate the Drugs to thePparticipants, a code will be Placed on the box of the Drugs. The Researcher is Unaware of the Type of Intervention and After Analyzing the Data, the Package Codes will be Decoded. Considering that the Form of Drugs and their Consumption are not the same, one is in the form of Powder and the other is a Tablet, and Considering the Proven Therapeutic Effect of Inofolic Powder in the Treatment of Infertility, Placebo cannot be Considered. 3 Polycystic Ovarian Syndrome. Intervention 1: Intervention group: Patients in the Intervention Group Received Sitagliptin Tablets 50 mg Every 12 Hours Made by Abidi Company and Inofolic Powder Including 2000 mg Myoinositol and 200 mcg Folic Acid Made by Teb Mofid Nikan Every 12 Hours with their Routine Medications for 8 Weeks Before the Start of the IVF Cycle and then Embryo Transfer will be Done with Appropriate Quality, Embryo and Oocyte quality and the Level of Laboratory Criteria (LH, FSH, FBS, Testosterone) and BMI will be Checked. Intervention 2: Control group: Patients in the Control Group Received Inofolic Powder Including 2000 mg Myoinositol and 200 mcg Folic Acid Made by Teb Mofid Nikan Every 12 Hours with their Routine Medications for 8 Weeks Before the Start of the IVF Cycle and then Embryo Transfer will be Done with Appropriate Quality, Embryo and Oocyte quality and the Level of Laboratory Criteria (LH, FSH, FBS, Testosterone) and BMI will be Checked. 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 Find the best way to publish
public Fateme Foroozanfard
Ghotbe Ravandi Blv, Kashan Medical Science University
Kashan Iran (Islamic Republic of) 8715981151 +98 31 3457 4191 fatemehforoozanfard@yahoo.com Kashan University of Medical Sciences scientific Mahdis Rajabi
Ghotbe Ravandi Blv, Kashan Medical Science University
Kashan Iran (Islamic Republic of) 8715981151 +98 31 3457 4191 Mahdiis174@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) People with Polycystic Ovarian Syndrome Age Between 18 and 40 Years People who are Known Case of Polycystic Ovarian Syndrome Based on Sonographic and Laboratory Findings Contained in the Case file People who are Candidates for Infertility Treatment and ICSI Based on Infertility Records 18 years 40 years Female People with Uterine Abnormalities (such as Asherman's Syndrome, Fibroids, Polyps, and a Diagnosis of Adenomyosis) Contraindications for Inositol and Sitagliptin Treatment Cycles with Embryo Donation or Prenatal Genetic Screening Endometriosis and Infertility with Unknown Cause Severe Male Factor Infertility E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Patients in the Intervention Group Received Sitagliptin Tablets 50 mg Every 12 Hours Made by Abidi Company and Inofolic Powder Including 2000 mg Myoinositol and 200 mcg Folic Acid Made by Teb Mofid Nikan Every 12 Hours with their Routine Medications for 8 Weeks Before the Start of the IVF Cycle and then Embryo Transfer will be Done with Appropriate Quality, Embryo and Oocyte quality and the Level of Laboratory Criteria (LH, FSH, FBS, Testosterone) and BMI will be Checked Control group: Patients in the Control Group Received Inofolic Powder Including 2000 mg Myoinositol and 200 mcg Folic Acid Made by Teb Mofid Nikan Every 12 Hours with their Routine Medications for 8 Weeks Before the Start of the IVF Cycle and then Embryo Transfer will be Done with Appropriate Quality, Embryo and Oocyte quality and the Level of Laboratory Criteria (LH, FSH, FBS, Testosterone) and BMI will be Checked Oocyte Quality. Timepoint: 8 Weeks Later Use of Medications. Method of measurement: Microscope. Embryo Quality. Timepoint: 8 Weeks Later Use of Medications. Method of measurement: Microscope. Body Mass Index. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Dividing Weight by Height to the Power of 2. Luteinizing hormone. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA test. Follicle stimulating hormone. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA test. Fasting Blood Sugar. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA test. Testosterone. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA test. Kashan University of Medical Sciences Approved 2023-12-11 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi blv, Kashan Medical Science University Kashan Isfehan Iran (Islamic Republic of)