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IRCT20200421047152N3 IRCT 2023-08-21 Iran University of Medical Sciences Protective effect of simvastatin on inflammatory factor Investigating the protective effect of simvastatin on inflammatory factors in infertile women who are candidates for In vitro fertilization (IVF) 2023-09-06 anticipated 84 Complete https://irct.ir/trial/71990 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done with a block size of 6. Sealedenvelode.com software will be used to generate a random sequence. For concealment, the generated sequence will be provided to a third party independent of the study team and will be revealed individually to the allocating person using A and B codes, Blinding description: This study will use a placebo similar in shape and color to simvastatin for blinding. An independent pharmaceutical company manufactures this placebo. Patients are generally aware of the existence of the placebo group in the study, but they are unaware of the group in which they are personally placed. Pills will be given to the care provider and then to the patients in identical packages with A and B coding. 2-3 Unexplained female infertility. Intervention 1: Intervention group: Patients of this group will receive simvastatin 20 mg daily orally for 45 days before the start of the ovarian stimulation cycle. After the end of the intervention, ovarian stimulation will be done using a gonadotropin-releasing hormone (GnRH) antagonist treatment regimen. Then, after the ovarian puncture, they will undergo in vitro fertilization (IVF) and embryo transfer. Intervention 2: Control group: Patients in this group will receive a placebo, which is identical with simvastatin tablets in form, orally for 45 days before the start of the ovarian stimulation cycle. After the end of this period, ovarian stimulation will be done through a gonadotropin-releasing hormone (GnRH) antagonist treatment regimen. and then after ovarian puncture, they will be subjected to vitro fertilization (IVF) and embryo transfer. 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 The intellectual property of the data is with the sponser.
public Azra Motaghinejad
Bagh-ferdous station, Molavi street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 monamotaghinejad67@yahoo.com Iran University of Medical Sciences scientific Mojgan Javedani
Bagh-ferdous station, Molavi street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 javedani46@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Women between 20-40 years old with unexplained infertility Serum Tumor Necrosis Factor (TNFα) > 5 pg/ml 20 years 40 years Female History of liver, kidney and muscular diseases History of metabolic diseases such as diabetes or thyroid dysfunction History of organic or function genital disorder History of medication with neurological , cardiovascular and metabolic drugs N97.8 Female infertility of other origin Treatment - Drugs Placebo Intervention group: Patients of this group will receive simvastatin 20 mg daily orally for 45 days before the start of the ovarian stimulation cycle. After the end of the intervention, ovarian stimulation will be done using a gonadotropin-releasing hormone (GnRH) antagonist treatment regimen. Then, after the ovarian puncture, they will undergo in vitro fertilization (IVF) and embryo transfer. Control group: Patients in this group will receive a placebo, which is identical with simvastatin tablets in form, orally for 45 days before the start of the ovarian stimulation cycle. After the end of this period, ovarian stimulation will be done through a gonadotropin-releasing hormone (GnRH) antagonist treatment regimen. and then after ovarian puncture, they will be subjected to vitro fertilization (IVF) and embryo transfer. Serum level of Tumor Necrosis Factor (TNFα). Timepoint: Screening, End of intervention (day 45). Method of measurement: Elisa technique. Interleukin 1 serum level. Timepoint: Screening, End of intervention (day 45). Method of measurement: Elisa technique. Humanuman chorionic gonadotropin Beta (βhCG). Timepoint: Two weeks after embryo transfer. Method of measurement: Elisa technique. C reactive protein serum level. Timepoint: Screening, End of intervention (day 45). Method of measurement: Immunoturbidimetry. Clinical Pregnancy. Timepoint: 5 weeks after embryo transfer. Method of measurement: Detection of fetal heart rate (FHR) in trans-vaginal ultrasound. Adverse Events. Timepoint: During the study period from randomization to the end of the first month after embryo transfer. Method of measurement: Interview and physical examination. Iran University of Medical Sciences Approved 2021-06-07 IUMS Biomedical Research Ethics Committee Next to Milad Tower ,Hemat Highway Tehran Tehran Iran (Islamic Republic of)