Infertility Clinical Trial
Official title:
Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients
Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. Statins inhibit proliferation of several cell types including vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine tumors characterized by smooth muscle proliferation and excessive deposition of extracellular matrix. In the present study we aim to evaluate the effect of simvastatin on uterine leiomyoma development and growth.
The proposal of the present study approved by our institutional review boards and
institution's ethical committee, and all participants will sign a written consent before
enter to study. All 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.
CBC, Lipid profile, kidney & Liver function tests, FBS & hormonal evaluation will be
performed before and after the treatment. Ultrasound examination will be performed before and
after the treatment for determining of the number, size, and site of the myoma and also size
of the uterus.
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