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IRCT20200825048515N24 IRCT 2021-02-20 Esfahan University of Medical Sciences The effect of metronidazole and levofloxacin on increased IVF success rate Evaluation of the effect of oral metronidazole and levofloxacin on increased IVF success rate after at least two failed IVFs 2021-02-19 anticipated 260 Complete https://irct.ir/trial/54249 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 260 eligible couples will be non-randomly selected. Then random numbers are created by computer software "Random Allocation" and are automatically divided into two parts. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to a patient (a couple) and therefore they will be randomly assigned to one of the two study groups, Blinding description: In this study, two drugs "metronidazole with levofloxacin" and "placebo" were prepared by a pharmacist with similar shape, color, smell, and size and placed in coded packages, and provided to the researcher. He/She prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. 3 Infertility. Intervention 1: Intervention group: Couples (both men and women) are treated with metronidazole 500 mg oral tablet once every 12 hours for 14 days and levofloxacin 500 mg oral tablet once daily for up to seven days. At the end of the course of antibiotic treatment, IVF will be performed for the couple at the same time as the ovulation of the next cycle. Intervention 2: Control group: Couples (both men and women) are treated with two placebo pills every twelve hours, one for 14 days and one daily for seven days. At the end of the course of antibiotic treatment, IVF will be performed for the couple at the same time as the ovulation of the next cycle. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Elham Naghshineh
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3234 6338 naghshineh@med.mui.ac.ir Esfahan University of Medical Sciences scientific Elham Naghshineh
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3234 6338 naghshineh@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Couples (male and female) diagnosed with previous unexplained infertility History of at least two previous failed IVFs Do not take antibiotics in the last trimester or before previous IVFs Absence of diabetes and chronic kidney disease in couples Couple consent to participate in the study no limit no limit Both Allergy to the studied antibiotics N97.9 Female infertility, unspecified Treatment - Drugs Placebo Intervention group: Couples (both men and women) are treated with metronidazole 500 mg oral tablet once every 12 hours for 14 days and levofloxacin 500 mg oral tablet once daily for up to seven days. At the end of the course of antibiotic treatment, IVF will be performed for the couple at the same time as the ovulation of the next cycle. Control group: Couples (both men and women) are treated with two placebo pills every twelve hours, one for 14 days and one daily for seven days. At the end of the course of antibiotic treatment, IVF will be performed for the couple at the same time as the ovulation of the next cycle. Serum βHCG level. Timepoint: 14 days after IVF. Method of measurement: ELISA method. Isfahan University of Medical Sciences Approved 2020-09-15 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)