Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2025-12-24 @ 6:46 PM
NCT ID:
NCT03134157
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT03134157
Study Brief:
Protocol Section:
NCT03134157