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Leiomyoma clinical trials

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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: NCT03796130 Recruiting - Fibroid Uterus Clinical Trials

Does Myomectomy for Intramural Fibroid Improve ART Outcome?

MIFART
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial will examine whether myomectomy in those patients could improve the results.

NCT ID: NCT03792009 Recruiting - Adenomyosis Clinical Trials

Paracervical Block in Laparoscopic Hysterectomy

PALAPA
Start date: February 21, 2019
Phase: N/A
Study type: Interventional

It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.

NCT ID: NCT03757975 Recruiting - Fibroid Uterus Clinical Trials

Impact of Hysterectomy on Quality of Life and Urethral Length

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

To establish the impact of hysterectomy on sexual function, urethral length and quality of life

NCT ID: NCT03550703 Recruiting - Leiomyoma Clinical Trials

Open Label Immunotherapy of Myoma

V3-myoma
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

NCT ID: NCT03509168 Recruiting - Uterine Fibroid Clinical Trials

The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy.

MM
Start date: January 10, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Open myomectomy remains the principal treatment for symptomatic fibroids in sub-Saharan countries irrespective of fertility desires. This however has got to be balanced against potential risks such as profuse hemorrhage; blood loss at open myomectomy remains dreary with the use of various pharmacologic agents yielding inconclusive results. This trial is aimed at exploring the benefit of preoperative use of a readily available uterotonic, Misoprostol in reduction of intraoperative blood loss during open myomectomy with the Null hypothesis stating: there is no difference in mean blood loss during open myomectomy whether one preoperatively inserts a single dose of 400mcg vaginal misoprostol or not. Alternate hypothesis: single dose 400mcg vaginal Misoprostol given 60 minutes preoperatively during open myomectomy reduces intra-operative blood loss by at least 20% as measured by surgical mops and suction. Participants from two referral hospitals in Uganda with symptomatic fibroids and scheduled for open myomectomy will be recruited. 48 women that meet the inclusion criteria and have none of the exclusion criteria and provide signed informed consent will be enrolled. The screening will be done on the gynecological wards and patients will be randomized to either the control or interventional arm by means of sealed, sequentially numbered opaque envelopes containing computer-generated random numbers. Blinding will affect theatre team and patients. Primary (blood loss as estimated by surgical mops and suction) and secondary endpoints (e.g. postoperative drop in Hb) will be calculated. Data analysis: Data will be analyzed on an intention-to-treat basis. Analysis will be done using STATA software 14.0. This will include descriptive statistics for measures of central tendency and dispersion. Student t-test and Mann Whitney U test will be used for mean blood loss. Stratification for age, parity, complaints, total fibroid mass and usage of other intraoperative blood-loss techniques will be analyzed. categorical data to be analyzed by coefficients. Results of this study are meant to better inform clinicians about the use of misoprostol for this role and possibly include it in the management protocols for open myomectomy in Sub-Saharan countries where burden of blood products is strained.

NCT ID: NCT03500367 Recruiting - Uterine Fibroids Clinical Trials

Efficacy and Safety of Rapamycin (Sirolimus) in the Treatment of Symptomatic Uterine Fibroids and Leiomyomatosis

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

A prospective non-randomized open label clinical trial to research the efficacy and safety of sirolimus in patients with symptomatic, recurrent uterine fibroids or/and various rare leiomyoma.

NCT ID: NCT03483142 Recruiting - Blood Loss Clinical Trials

the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation

Start date: November 1, 2017
Phase: Phase 3
Study type: Interventional

assess the effect of using misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications. Research question Does pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy operation ?. Research hypothesis Pre-operative misoprostol may reduce intra-operative blood loss during and after myomectomy operation .

NCT ID: NCT03400826 Recruiting - Leiomyoma Clinical Trials

Effects of Simvastatin on Uterine Leiomyoma Size

Start date: August 20, 2018
Phase: Phase 2
Study type: Interventional

The study aims to study the effect of simvastatin on the size of uterine fibroids.

NCT ID: NCT03134157 Recruiting - Infertility Clinical Trials

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

Start date: August 2016
Phase: Phase 3
Study type: Interventional

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.