Comparison of the Effectiveness of Simvastatin on Uterine Leiomyoma Development in Infertile Women

Comparison of the Effectiveness of Simvastatin on Uterine Leiomyoma Development in Infertile Women

A randomized, double-blind controlled clinical trial with parallel groups design of 60 patients

60 eligible infertile patients with uterine fibroid who will refer to infertility clinic of Royan Institue for infertility treatment and are underwent ART will be entered the study with ethic consideration.

• Women with age between 20-40 years, intramural fibroids confirmed by ultrasound, presence of at least one fibroid with size >4 cm or two fibroids with size >3 cm detected by pelvic ultrasound, presence of at least 3 fibroids with size <3 cm and a history of 2 IVF failures, number of fibroids ≤ 5, Body Mass Index >25 Kg/m2 include the study. The women with severe male factor infertility, severe endometriosis, diminished ovarian reserve, breastfeeding, Pregnancy, Hb ≤ 7, alcohol consumption, allergic to simvastatin, signs or symptoms of muscle aches, muscle weakness, myopathic syndrome, mental illness, hepatic dysfunctions, renal disease, cardiovascular disease, hypotension ,diabetes mellitus, hypothyroidism, neuropathy, lupus, cataract and cancer, transaminase abnormalities and taking antifungal medications, lipid-lowering medications (gemfibrozil, clofibrate and…), warfarin, danazol and erythromycin in the last one month don’t include the study.

Patients will be randomly divided into three groups and will be randomized to receive simvastatin 40 mg orally + vaginal placebo; simvastatin 40 mg vaginally + oral placebo and vaginal placebo + oral placebo for 3 months.

Uterine fibroid size, Uterine size, uterine bleeding

A randomization list was provided by statistic using randomization website (block randomization with block size of 6) and allocation was performed by a third party not directly connected with the trial.

As soon as the patient is entered into the study, the treatment code is determined from the randomly generated sequence and a unique identification code is assigned to the patient. Random codes are stored in the main project management unit of the study and are inqueried through the clinical caregiver and the relevant intervention will be applied to the new patient. For this purpose, after determining the patient eligibility, the clinical caregiver, inquiries from the project management unit and announces the patient information and receives the patient's assigned identification and treatment code. Therefore, the clinical caregiver will not be aware of the allocative treatment until the patient is admitted. The drug Medicine packages are given to the clinical caregiver by the code they are registered with. All placebo tablets are provided by Hakim Pharmaceutical Company (Tehran, Iran), approved by the Iranian Food and Drug Administration. The appearance of placebo tablets is in color, shape and size quite similar to simvastatin tablets, which cannot be detected by patients, clinical care giver and researcher.