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Leiomyoma clinical trials

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NCT ID: NCT05448365 Recruiting - Uterine Fibroids Clinical Trials

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.

NCT ID: NCT05442827 Recruiting - Clinical trials for Uterine Fibroids With Menorrhagia

A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids

Start date: September 10, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Phase II:To explore the optimal effective dose of SHR7280 tablets in subjects with menorrhagia with uterine fibroids as a phase III treatment dose. Phase III:To evaluate the efficacy of the selected dose of SHR7280 compared with placebo in reducing menstrual bleeding in subjects with menorrhagic uterine fibroids in phase II studies.

NCT ID: NCT05416424 Recruiting - Uterine Fibroid Clinical Trials

Life Study: Lifestyle Intervention in Fibroid Elimination

Start date: May 23, 2022
Phase: N/A
Study type: Interventional

The study will evaluate a lifestyle, nutrition, and exercise program to assess whether this program is acceptable and feasible for patients..Researchers will examine if the LIFE program can modify fibroid recurrence.

NCT ID: NCT05409872 Recruiting - Leiomyoma, Uterine Clinical Trials

Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids

DEFIB
Start date: September 15, 2022
Phase: N/A
Study type: Interventional

Randomized (1:1) double-blind, single-center controlled trial to evaluate the efficacy of 3 months of treatment with Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 on symptoms related to uterine fibroids

NCT ID: NCT05386615 Recruiting - Uterine Fibroid Clinical Trials

Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids

Start date: February 16, 2016
Phase:
Study type: Observational [Patient Registry]

The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.

NCT ID: NCT05364008 Recruiting - Leiomyoma, Uterine Clinical Trials

FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea

FRIEND
Start date: January 5, 2023
Phase: Phase 3
Study type: Interventional

The objective of this study is to determine the effect of low caffeine green tea extract containing 45% epigallocatechin gallate (EGCG) on fibroids and subsequent pregnancy and live births in women seeking fertility treatment. The population will consist of 50 women desirous of conceiving, ages ≥18 to ≤40 years (at time of consent), and known to have class 2-6 fibroids, according to the FIGO staging system.

NCT ID: NCT05271981 Recruiting - Fertility Disorders Clinical Trials

Fertility After Uterine Artery Embolization

FERTI-EMBOL
Start date: November 23, 2022
Phase:
Study type: Observational

Uterine leiomyomas (or fibroids) are a common disease (30% of women over 35 years of age) in women of childbearing age and can cause various symptoms such as menometrorrhagia, dysmenorrhoea, pelvic pain and heaviness, and infertility. Uterine artery embolisation, first used in France in 1990, is a safe, effective and less invasive therapeutic technique than surgical treatment (myomectomy or hysterectomy), particularly in the case of numerous and large fibroids. This technique is validated by the French National College of Gynaecologists-Obstetricians (CNGOF) as an alternative treatment for women who do not wish to become pregnant (grade A recommendation), but at present there is little reliable data concerning fertility, the occurrence of pregnancy and the obstetrical prognosis after uterine artery embolisation for fibroids. A recent systematic review of the literature with meta-analysis published very recently showed that 40.5% of patients with a desire for pregnancy were able to become pregnant after embolisation (CI: 33.3%-48.2%) but that the rates of miscarriage, obstetric complications and low birth weight were not negligible (respectively 33.5% (95% CI: 26.3-41%), 25.4% (95% CI = 13-40.2%) and 10% (95% CI = 6.2-14.6%) (Ghanaati et al. 2020). In France, uterine artery embolisation is performed in more than thirty centres in women who have completed their parental project. On the other hand, in the absence of consistent literature, it is performed in patients of childbearing age, when it represents the only acceptable alternative or in the event of contraindication or refusal of surgery by the patient. To our knowledge, there is no large-scale French study to date on the impact of embolisation on fertility and pregnancy outcomes. The aim of this study is to compile a retrospective database of all cases of uterine artery embolisation for uterine pathology performed at the Georges-Pompidou European Hospital (HEGP) since 2007 and to assess the impact of embolisation on fertility in patients of childbearing age.

NCT ID: NCT05153928 Recruiting - Clinical trials for Abnormal Uterine Bleeding

Management of Uterine Leiomyomata and Adenomyosis

Start date: April 10, 2021
Phase:
Study type: Observational

1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination 2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

NCT ID: NCT05129956 Recruiting - Clinical trials for Obstetric/Gynecology

Sonoguided-microwave Uterine Myoma

myoma
Start date: August 6, 2021
Phase: N/A
Study type: Interventional

This study mainly evaluates the resolution of uterine fibroids by microwave ablation. The medical equipment used is Ke Hui. "The Ampening ablation system is a percutaneous surgery. During laparoscopic surgery, it is directly ablated and soft, including problems that cannot be solved by partial or complete tissue ablation. "Hydrogen is used. If the expected range of ablation can be found, there is no need to wait for 3 to 6 months for ablation slowly like Haifu surgery. A fast, small, high-quality treatment that provides reference for medical treatment and helps doctors choose the most suitable treatment.

NCT ID: NCT05078307 Recruiting - Uterine Fibroids Clinical Trials

Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids

VAPOHYSTERO
Start date: September 25, 2021
Phase: N/A
Study type: Interventional

Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Thus, when there is a large fibroid or several fibroids, this technique can sometimes not be used or require several sessions. Today there is a new technique of HO that theoretically allows a gain in operative time. There are few comparative studies showing a clinically interesting gain in operating time. The aim of this study is to compare the operative time between the classical HO technique by resection and the vaporization technique. This is a randomized, single-center study. The study population corresponded to women aged over 18 years requiring operative hysteroscopy for fibroids. After obtaining informed consent, patients will be randomized into two groups: a vaporization hysteroscopy group and a resection hysteroscopy group. The primary endpoint will be operative time. The secondary endpoints will be intraoperative characteristics and complications (amount of distension fluid used, cervical injury, uterine perforation), immediate postoperative data (pain) and medium-term data (postoperative synechiae). The starting hypothesis is that the technique of hysteroscopy by vaporization would reduce the operative time by 30%. The number of subjects required per group will be 27 patients, or 54 patients in total over 24 months. The expected results are a significant decrease in operative time with the vaporization hysteroscopy technique. This would be important because the reduction in operative time is associated with a reduction in complications of operative hysteroscopy and the possibility of treating larger fibroids with this technique.