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Leiomyoma clinical trials

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NCT ID: NCT04028986 Active, not recruiting - Infertility, Female Clinical Trials

Esmya Versus Surgery Before IVF/ICSI

Start date: January 1, 2016
Phase:
Study type: Observational

Studying the possible outcome differences between surgery or medical treatment with ulipristalacetate (UPA) solely before 'in-vitro fertilisation/intracytoplasmic sperm injection' (IVF/ICSI) treatment in infertile couples.

NCT ID: NCT04004884 Terminated - Clinical trials for Treatment Side Effects

Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids (LISA)

LISA
Start date: May 23, 2019
Phase:
Study type: Observational

Uterine fibroids are are the most common gynecological tumor. Among the pharmacological treatment options, ulipristal acetate (UPA) has proven to be effective in control of bleeding and reduction of size of fibroids. Due to the appearance of some cases of subacute severe hepatic insufficiency in patients undergoing UPA treatment and the possible idiosyncratic effect of the drug, the European Medicine Agency (EMA) recommended performing liver function tests before, during and after each UPA treatment course as a minimization risk strategy to prevent drug induced liver injury (DILI). The aim of the present study is to evaluate whether changes in transaminase levels or other DILI markers occur in patients receiving UPA in our center.

NCT ID: NCT03993210 Terminated - Gynecologic Tumor Clinical Trials

The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids

Start date: September 18, 2019
Phase: N/A
Study type: Interventional

This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting and Q-space Trajectory Imaging in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI.

NCT ID: NCT03991078 Recruiting - Clinical trials for Size of the Uterine Fibroids

Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency

Start date: July 9, 2019
Phase:
Study type: Observational

Vitamin D supplementation in patients with uterine fibroids who present hypovitaminosis D to re-establish their normal serum values could stabilize the size of the uterine fibroids and thus prevent their growth or reduce their size thanks to the anti-proliferative action of Vitamin D on the myoma cells.

NCT ID: NCT03989661 Completed - Uterine Fibroid Clinical Trials

Is There a Place for Pre-operative Temporary Embolization of Uterine Fibroids

EMBOFIB
Start date: July 12, 2019
Phase:
Study type: Observational

Uterine fibroids are the most common benign tumors of the female genital tract, with an estimated incidence of 25-80% during the reproductive period in the general population. If the affected patients do not usually have any symptoms, uterine fibroids may also, depending on their location, be responsible for acute and chronic pelvic pain, bleeding and infertility. Symptomatic uterine fibroids are now treated in the first line by surgery (hysterectomy, laparotomy myomectomy, laparoscopy or hysteroscopy). When conservative treatment is indicated and the fibroid is not hysteroscopically accessible, myomectomy can be performed by laparotomy or laparoscopy. Excision of myomas often richly vascularized exposes the surgeon and the patient to a risk of bleeding per- and / or post-operative sometimes severe, resulting in an increase in operating times, an increased risk of postoperative complications and need transfusion. The literature is rather poor on this subject but some factors favoring bleeding have been identified: the history of myomectomy, a uterine volume equivalent to more than 20 weeks of amenorrhea, the excision of more than 10 fibroids, or an incisional approach. In order to reduce these intraoperative bleeds, numerous therapeutic strategies have been developed, using drug alternatives (GnRH agonists, Ullipristal) or interventional radiology (embolisation of the uterine arteries). The improvement of interdisciplinary collaboration is now seeing the emergence of numerous therapeutic strategies combined. The effectiveness of uterine artery embolization has been demonstrated for several years in the treatment of fibroids, alone or in combination with surgical myomectomy. Some studies on preoperative embolization (maximum 24 hours before the intervention) have shown encouraging results with regard to the volume of bleeding, the need for per or post-operative transfusion or the need for surgical revision, or even decision to hystérectomie. In 2011, Butori et al. propose the use of absorbable spongy particles (Curaspon type) for preoperative embolization. The use of these resorbable particles would reduce the risk of postoperative synechia. Some studies indicate that embolization of the uterine arteries using non-absorbable material would be responsible for ovarian failure by hypo-infusion. The use of absorbable material would avoid this adverse effect while preserving its effectiveness for the surgical procedure, but to date no study clearly demonstrates this. This retrospective case-control study aims to compare the occurrence of per-and post-operative adverse effects between a test group consisting of patients who had undergone preoperative embolization (with resorbable material) before myomectomy (intervention group) and a control group with myomectomy without embolization (control group).

NCT ID: NCT03985449 Completed - Uterine Fibroid Clinical Trials

Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings

UPFRONT
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

UPFRONT is a study that aims to use two implementation frameworks - the Consolidated Framework for Implementation Research and the Normalization Process Theory - to guide the implementation of a uterine fibroid patient decision aid, known as Option Grid, at five diverse gynecology settings across the United States. Option Grid provides evidence-based information on the various treatment options to help women across socioeconomic strata with symptomatic uterine fibroids make a preference-sensitive decision.

NCT ID: NCT03972917 Completed - Dysmenorrhea Clinical Trials

Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy

Start date: November 1, 2018
Phase:
Study type: Observational

A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.

NCT ID: NCT03948789 Recruiting - Uterine Fibroids Clinical Trials

Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy

Start date: July 15, 2020
Phase: Phase 3
Study type: Interventional

The aim of the study is to answer the question, whether in patients with symptomatic and medically not sufficiently treatable uterine fibroids (population) the "Magnetic-Resonance-Guided Focused Ultrasound Surgery" short, MRgFUS-TUF (intervention) offers less burdensome therapy and patient-relevant advantages (symptom relief) compared to the operative myomectomy (comparison). The study will hence investigate the therapeutic benefit of this method.

NCT ID: NCT03937401 Enrolling by invitation - Adenomyosis Clinical Trials

Oxytocin in MRI-HIFU

Start date: February 1, 2019
Phase: Phase 4
Study type: Interventional

Capability of oxytocin in improving the efficacy of MRI-HIFU is studied. Patients undergoing MRI-HIFU treatment are given oxytocin during treatment and the efficacy of the treatment will be analysed by patient reported symptom questionnaires and imaging data.

NCT ID: NCT03930069 Completed - Clinical trials for Submucous Leiomyoma of Uterus

Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

Start date: May 2, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .