View clinical trials related to Leiomyoma.
Filter by:The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the problem of clarifying the management tactics of pregnant patients with symptomatic fibroids, who may see their preg-nancy put at risk by these masses.
Uterine fibroids, affecting 20-50% of all women ,and are benign tumors that arise from myometrial cells of the uterine smooth muscle tissue. Although most are asymptomatic, fibroids can often cause abnormal uterine bleeding, iron deficiency anemia, pelvic pressure symptoms and pain
This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.
This is a single-arm clinical trial evaluating the safety and efficacy of ultrasound-guided HIFU (Sonotrip V20) for symptomatic uterine fibroids. 57 cases will be enrolled at a Korean institution. Participants will undergo the HIFU procedure based on a pre-established plan using MRI images. Assessments will be conducted immediately post-procedure and at 4 and 24 weeks. Primary endpoint is fibroid volume reduction at 24 weeks, with secondary endpoints including Non-Perfused Volume Ratio, quality of life, hemoglobin change, pain assessment, and additional medication use. Adverse events will be monitored.
Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the instrumentalization and the need of cervical dilation, the use of local anesthesia, with or without sedation, is recommended. The different alternatives described in the literature are the following: 1. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix. 2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions. 3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity. 4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the cervix. To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a prospective multicentric study that compare two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.
In 2% to 3% infertility women, myoma is the only factor relevant to their infertility. However, the effects of intramural myoma on fertility are controversial. For infertile women with intramural myoma (types IV, V, VI of FIGO system) of 4 to 6 cm diameter, it is not clear whether myomectomy could improve pregnancy outcomes, especially in women undergoing ART. Besides, rigorous clinical research is needed to explore the changes and relevant biomarkers of endometrial receptivity through multi-omics study in patients undergoing myomectomy and ART treatment. Method Intervention and follow-up: (1) For the control group, evaluation protocols such as salpingography and/or laparoscopic tubal fluxation should be implemented to identify disorders such as hydrosalpinx. (2) Imaging evaluation: all pelvic MRI were performed. Other options such as transvaginal ultrasound are not excluded, but won't replace MRI. Enhanced MRI or DWI may be considered, but are not always required. (3) Surgical intervention: laparoscopic myomectomy is preferred, and abdominal myomectomy is also acceptable. (4) IVF treatment: the IVF regimen should include detailed records of the downregulation plan, number of cycles, frozen or fresh blastocysts. Study endpoints (1) Primary study endpoint: Live birth rate after IVF. (2) Secondary study endpoints: Clinical pregnancy rate after IVF; Cumulative pregnancy rate after IVF; Biochemical pregnancy rate after IVF; Sustained pregnancy rate after IVF (≥20 weeks); Miscarriage rate after IVF; Cycles of IVF; Pregnancy-related complications; Perinatal maternal and neonatal complications. (3) Exploratory endpoints: The correlation between imaging index and assisted reproductive outcomes, including endometrial thickness, uterine volume, type of endometrial echo, uterine contraction; endometrial vascular index (VI), flow index (FI), tubular flow index (VFI); uterine artery pulsation index (PI), uterine artery resistance index (RI), systolic/diastolic blood pressure of uterine artery (S/D). The correlation between endometrial receptivity and assisted reproductive outcomes is analyzed based on transcriptomics, metabolomics, methylation and proteomics in samples from peripheral blood, endometrial biopsy, endometrial exfoliated cells, cervical exfoliated cells and myoma.
ImpactRA is an observational retrospective study. The management of the patient is not modified by this study. This study will be carried out based on the already existing data of the gynecological ward of CHU Clermont-Ferrand between 2016 and 2021. During this period of time, 17 patients have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, aided by augmented reality (AR). The investigators compared these 17 patients that underwent surgery with AR with 17 control patients that underwent the same surgery with the same indication but without AR.
Transcervical resection of myoma(TCRM) has a good therapeutic effect while the probability of complete resection of type I and II fibroids is only 55% per procedure on average and a significant number of patients have fibroid remained.At present, there is no standardized treatment option for reducing the remaining submucous fibroids volume and preventing its recurrence after TCRM.The present prospective,multicentre,randomised controlled clinical trial will enrol women after TCRM and treat them with mifepristone(10mg)or GnRHa(3.60mg)for 3 to 6 months,investigating the effective and cost-effective treatment options after fibroids with TCRM，thus to provide evidence and effectual regiments for reducing remaining fibroids volume and preventing its recurrence.
To assess the relative bioavailability of SHR7280 dry suspension and tablets in healthy subjects. To assess the safety and tolerability of a single dose of SHR7280 dry suspension and tablets.
The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.