The Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients

Conditions
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Infertility

Intervention / Treatment
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* Drug: oral drug and vaginal placebo
* Drug: oral drug and oral placebo
* Drug: Vaginal placebo+ oral placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 BMI>25 Kg/m2 Exclusion Criteria: Pregnancy Hormonal contraception or any hormonal therapy received in the last 3 months Alcohol consumption Allergic to simvastatin Suspicion or diagnosis of cancer Signs or symptoms of mental illness, hepatic dysfunction, myopathic syndromes, diabetes mellitus, renal disease, Cardiovascular disease, hypothyroidism, hypotension, neuropathy, lupus and cataract Hb ≤ 7 Taking antifungal medications, Lipid-Lowering medications (gemfibrozil, clofibrate), warfarin, danazol and erythromycin in the last one month. Severe male factor Severe endometriosis Diminished ovarian reserve

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin and vaginal placebo<br>The patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months. | Drug: oral drug and vaginal placebo<br>* prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.<br>|
| Experimental: Simvastatin and oral placebo<br>The patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months. | Drug: oral drug and oral placebo<br>* prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.<br>|
| Experimental: Vaginal placebo+ oral placebo<br>The patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months. | Drug: Vaginal placebo+ oral placebo<br>* prescription of Vaginal placebo + oral placebo every day for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine fibroid size | Evaluation the size of Uterine fibroid withultrasound. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine size | Evaluation the uterine size with ultrasound. | 3months | 
| Plasma concentration of Vitamin D3 | Evaluation the Plasma concentration of Vitamin D3 with blood sampling. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyoma simvastatin infertility