Infertility
Conditions
Keywords
Leiomyoma simvastatin infertility
Brief summary
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
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.
Interventions
DRUGoral drug and vaginal placebo
prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.
DRUGoral drug and oral placebo
prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.
DRUGVaginal placebo+ oral placebo
prescription of Vaginal placebo + oral placebo every day for 3 months.
Sponsors
Royan Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uterine fibroid size | 3 months | Evaluation the size of Uterine fibroid withultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine size | 3months | Evaluation the uterine size with ultrasound. |
| Plasma concentration of Vitamin D3 | 3 months | Evaluation the Plasma concentration of Vitamin D3 with blood sampling. |
Countries
Iran
Contacts
Primary ContactNasser Aghdami, MD,PhD
Backup ContactLeila Arab, MD
Outcome results
None listed