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Fibroid clinical trials

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NCT ID: NCT06143631 Not yet recruiting - Leiomyoma Clinical Trials

Prescription of Letrozole for Uterine Myoma

PLUM
Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.

NCT ID: NCT06135870 Recruiting - Leiomyoma Clinical Trials

Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)

SOUL
Start date: November 1, 2023
Phase:
Study type: Observational

The investigators are evaluating the role of senescent cells in uterine fibroids.

NCT ID: NCT04736095 Completed - Fibroid Clinical Trials

3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

Start date: February 7, 2021
Phase:
Study type: Observational

• three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.

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: NCT03784976 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Iyengar Yoga Therapy for Dysmenorrhea and Endometriosis

Start date: July 3, 2018
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to look at the effectiveness of prescribing yoga classes to patients with dysmenorrhea (irregular or painful periods), or other menstrual disorders on patients' self reported pain and quality of life. Patients will be recruited from primary care clinics around Illinois, including Carle Hospital. This is a randomized trial in which patients will first be randomized into the control or intervention group. Patients in the control group will undergo usual care and be surveyed at baseline, 3 months, 6 months and 9 months. Patients in the control group will be offered the 3 months of yoga therapy complimentary after completing the 9 month control. Control patients who choose to participate in the yoga therapy will be asked to also complete the surveys at the end of the 3 month yoga intervention. Patients in the intervention group will first undergo 3 months of regular care and then 3 months of biweekly yoga classes. Participants will complete surveys at baseline, 3 months (after of control care), 6 months (after 3 months of biweekly yoga classes), 9 months, and 12 months (after 6 months of observation and optional yoga practice).

NCT ID: NCT03323905 Active, not recruiting - Leiomyoma Clinical Trials

Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

HIFUSB
Start date: November 16, 2017
Phase: N/A
Study type: Interventional

Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.

NCT ID: NCT03143114 Recruiting - Infertility Clinical Trials

Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women

Start date: May 15, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.

NCT ID: NCT03122782 Not yet recruiting - Surgical Blood Loss Clinical Trials

Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy

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

Study Design: Randomized Controlled Clinical Trial. Study Population: The study population will be a consecutive series of participants attending the Early Cancer Detection Unit (ECDU) at Ain Shams University Maternity Hospital. 80 women who are scheduled to undergo a hysteroscopic myomectomy will be included and will be randomized into two groups: Group A: women will undergo a hysteroscopic myomectomy with the use of (TXA) Kapron in the distention medium Group B: women will undergo hysteroscopic myomectomy with the use of placebo(normal saline in the distention medium). Randomization will be performed using a Computer-generated randomization system. The allocated groups will be concealed in serially-numbered sealed opaque envelopes that will only be opened after recruitment. Patient allocation will be performed prior to the induction of anesthesia by an independent person, who will not otherwise be involved in this study. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium. Therefore, this study will be a randomized double blind prospective clinical Methodology: 1. Informed written consent obtained from the participant. 2. History 1. Personal history 2. Menstrual history 3. Detailed obstetric history 4. Surgical intervention especially uterine surgeries and any post-operative complication 5. History of drug intake, especially hormonal treatment or anticoagulant therapy. 3. Routine preoperative investigations in addition to a serum pregnancy test if pregnancy is suspected. 4. Physical examination including general, abdominal and pelvic examination. 5. Hysteroscopy will be performed in the early proliferative phase using normal saline as a distention medium. 6. Only in intervention group (TXA group) KAPRON (Tranexamic acid) will be added to the injected media. - In intervention group 500 mg of Kapron for every 500 ml of distending media will be added. - In the control group, placebo .i.e. ,normal saline in the same form will be injected inside every 500 ml of the distention medium. 7. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium. Therefore, our study will be a randomized double blind prospective clinical trial. 8. Intraoperative bleeding and quality of view will be observed. 9. A blood sample will be taken from each participant in both groups after 24 hours from the end of the operation for both hemoglobin and hematocrit levels. Types of outcome measures: Primary outcome measures: Estimated Blood loss defined as comparing the hematocrit and hemoglobin at base line (preoperative ) and 24 hours after surgery with the Tranexamic acid compared to the control group. Secondary outcome measures: The quality of view, duration of surgery, the volume of injected media, intraoperative complications and the success of the completion of the operation will be secondary outcomes.

NCT ID: NCT02825719 Terminated - Fibroid Clinical Trials

Ulipristal Use in Chinese Population

Start date: December 2, 2015
Phase: Phase 4
Study type: Interventional

Uterine leiomyomas is the commonest benign tumour of the female genital tract. It lead to menorrhagia, anaemia, pain and pressure symptoms. Due to the enlarged uterus, the use of minimal invasive surgery is limited. There is also increase risk of intraoperative blood transfusion. Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). Preoperative use of Ulipristal for 12 weeks has been shown to decrease uterine bleeding, fibroid volume, pre-operative anaemia and symptoms severity. However there is still lacking evidence in terms of long term safety and efficacy, especially in Chinese population. The aim of the present study is to evaluate the effect and safety on preoperative use of Ulipristal on fibroid.

NCT ID: NCT02361905 Recruiting - Fibroid Clinical Trials

Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

Start date: February 2015
Phase: Phase 4
Study type: Interventional

Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. they often are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably related to degenerative changes induced by this treatment. Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.