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115 active trials for Endometriosis

Evaluation of Sestrin Levels in Patients With Endometriosis

Serum sestrin levels of endometriosis patients are compared with a group of healthy volunteers of the same age.

Start: February 2021

Patient Reported Outcomes After Surgery for Rectal Endometriosis

To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.

Start: December 2019

Central Sensitization and Outcome of Endometriosis Surgery

This study will evaluate whether the degree of central sensitization as measured by the questionnaire "central sensitization inventory CSI" is related to the outcome of surgical endometriosis treatment

Start: October 2019

Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery

An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery.

Start: September 2019

Turkish Validation Study of Endometriosis Health Profile -30 (EHP-30) Test

For the Turkish validation Study of the Endometriosis Health Profile test (EHP-30) consisting of 30 questions, this 30-question test will be applied to 228 patients after 2 different translations to be applied after the translation of this 30-question test sworn translator to the patients who have been surgically diagnosed with endometriosis.

Start: April 2021

Observational Study of Patients Suffering From Endometriosis and Adenomyosis

Endometriosis and adenomyosis are chronic difficult diseases affecting a significant proportion of reproductive age women. it is hoped that the investigators can collect the health profile of these participants using structured questionnaires on their quality of life, reproductive health, collect the sonographic characteristics, identify the risks factors of participants suffering from severe disease, and to propose the best treatment modality for different patient groups, both with and without fertility wish.

Start: April 2021

Microbiome and Immunologic Analysis - Women With Endometriosis

The primary goal of this study is to assess differences in the microbiome between women with and without endometriosis. A second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis. In order to investigate these areas of interest, 25 women with endometriosis and 25 women without endometriosis will be enrolled. All women will be undergoing a previously scheduled surgical procedure at which time presence or absence of endometriosis will be confirmed and specimens will be obtained.

Start: February 2020

IVF Versus Surgery for Endometriosis Related Infertility

The management of endometriosis-related infertility remains controversial. In particular, there is an equipoise for infertile women with endometriotic lesions detected at ultrasound. These women can be managed with either surgery or in vitro fertilization (IVF). The two approaches radically differ and they have never been compared with a randomized trial. As a consequence, affected women currently receive contrasting information and the mode of treatment substantially differ among centres, reflecting the local expertise of physicians rather than clinical needs. The present study aims at clarify whether IVF could be superior to surgery in infertile women with endometriotic lesions detected at ultrasound. This topic will be addressed comparing the two approaches in terms of effectiveness and cost-effectiveness. In addition, the study will disentangling whether the endometriosis-related systemic inflammatory mechanisms may have an impact on the quality of folliculogenesis and on IVF outcomes. This specific objective will be pursued through the characterization and analysis of circulating extracellular vesicles (EV)-immunologic, proteomic and miRNA signatures and measurement of steroid hormones in follicular fluid.

Start: March 2021

Percutaneous Radiofrequency Ablation of Parietal Endometriosis (PRFA)

Parietal endometriosis is the implantation of endometrial tissue in abdominal structures more superficial than the peritoneum. It is a rare form of the disease (incidence estimated between 0.04 and 12% among women operated on for endometriosis depending on the series) but is classically resistant to medical treatment and can be disabling. Surgical resection is currently the reference treatment in the event of failure of hormonal treatment, despite the sometimes significant skin scars and the risk of parietal fragility that may require a cure of venting by parietal prosthesis. The recurrence rate after surgical resection is 4.3%. The use of radiofrequency for therapeutic purposes is nowadays described in multiple applications such as cardiac arrhythmia, neurological and spinal disorders, as well as for the treatment of liver, kidney, prostate, breast, lung or skin cancers. Its use has already been reported in the field of benign gynecology with, in particular, demonstrated efficacy in the treatment of uterine fibroids by laparoscopic, trans-vaginal or percutaneous means. There are also large published series on radiofrequency for the treatment of adenomyosis, by the transvaginal and laparoscopic route. In the context of parietal endometriosis, this would be a minimally invasive, percutaneous treatment. Ultrasound guidance allowing good targeting of the lesions and the procedure would most often be carried out on an outpatient basis and under local anaesthesia. And in case of failure or partial effectiveness, the reference treatment would remain accessible for these patients. There is only one published case of the use of radiofrequency in parietal endometriosis (case reports). Despite results that seem encouraging in terms of a rapid and prolonged therapeutic effect on symptoms, no further cases or series have been published since. Our study aims to investigate the feasibility of percutaneous radiofrequency treatment for parietal endometriosis, with the secondary objective of evaluating the safety, efficacy and risk factors for failure of the technique. 10 patients will be treated. For follow-up all patients will have an ultrasound and MRI before treatment, then an ultrasound at 1 month, 3 months and 6 months post-treatment and a second MRI at 6 months post-treatment. The investigators will also evaluate pain and quality of life with specific questionnaires at each visit.

Start: June 2020

The Role of Galectins in the Non-invasive Diagnosis of Endometriosis

Endometriosis is one of the most common infertility-related gynecologic disorder that affect approximately 10-15% of women in reproductive age. The main symptoms are chronic pelvic pain, infertility, dysmenorrhea and dyspareunia. There exists an average diagnostic delay of 7 year but data widely varies between different countries. The current "gold standard" in the diagnosis of endometriosis remains a laparoscopy. Since laparoscopy is an invasive surgical procedure with its potential risk, the development of a non-invasive laboratory test would be of great benefit in the early, clinical management of this diseaseIn the past few years, lectins have become the focus of reproductive immunology, inflammation and autoimmunity. Galectins (Gal) are beta-galactoside binding lectins that play a key role in the regulation of the immune system, cell growth, adhesion, apoptosis, and angiogenesis. Until now 13 different types of galectins have been found in humans, among them Gal-1-4, 7-9 and 12 were detected in the normal endometrium. So far only Gal-1 and Gal-3 have been studied in relation to endometriosis. In a recent pilot study, the investigators have shown that Gal-9 levels are significantly elevated in the serum of endometriosis patients compared to healthy controls. Gal-9 had a high sensitivity (94%) and specificity (93,75%), indicating better diagnostic potential than that of other endometriosis biomarkers and of surgery as the current gold standard.

Start: September 2021

Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis

Endometriosis is a chronic inflammatory disease, frequently associated with dysmenorrhea, dyspareunia and abdomino-pelvic pain limiting quality of life. Most medical therapies aim to alleviate the severity of symptoms. Recent guidelines recommend the use of either OCPs or progestins as a first-line treatment of pain associated with endometriosis. The effectiveness of both OCPs and dienogest, a fourth-generation progestin, for endometriosis treatment has been demonstrated. The literature is rich with data comparing the use of Visanne or OCPs to placebo or GnRH analogs. However, there are no head to head studies comparing their efficacy in the management of endometriosis associated pain. The study aims to evaluate if Dienogest (Visanne) is not inferior in efficacy to oral contraceptive pills (Yasmin) in controlling pain associated with endometriosis?

Start: February 2017

An Observational Study of Patients With Endometriosis to Evaluate the Usefulness of the MEDL Score, a New Method for Evaluating Endometriosis Using MRI

The purpose of this study is to confirm the reproducibility that the MEDL score can be evaluated by Magnetic Resonance Imaging (MRI) in the similar way as laparoscopy, the gold standard for the evaluation of the disease state of endometriosis, in order to establish the MEDL score, a new evaluation index for endometriosis using MRI. Approximately 70-90 patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery will be recruited retrospectively or prospectively, and the disease status of endometriosis will be evaluated using preoperative MR images, laparoscopic surgery videos, etc. The relationship between the condition and clinical symptoms, such as pain, is also considered.

Start: April 2021

Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gynecological Diseases

This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from subjects with recurrent cervicovaginitis, subjects with endometriosis, subjects with repeated implantation failures and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological). The study will allow to: Provide biological samples (faeces, saliva, vaginal, urine) from healthy volunteers and patients suffering from selected disease to the first Italian microbiota biobank; Study microorganisms using different in vitro and in vivo techniques; Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.

Start: February 2021

Endocation: Pilot Randomized Cluster Controlled Trial of an Endometriosis Education Program

Endometriosis is a common condition that affects 10% of females, causing chronic pain and other health concerns. Currently, it takes 8-12 years to be diagnosed with endometriosis, in part because there is low awareness of this condition. This research is designed to test whether providing endometriosis education in schools can help increase early awareness of the condition.

Start: April 2021

Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis

This will be a randomised, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.

Start: June 2019

Endometriosis Pelvic Pain Interdisciplinary Cohort Data Registry

The purpose of this data registry is to prospectively collect data from patients referred to an interdisciplinary clinic for pelvic pain and endometriosis to investigate long-term patient outcomes, prognosis, predictors, causes, and treatment of pelvic pain and endometriosis.

Start: June 2016

Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome)

"Xuefu-Zhuyu capsule" (XFZY) is made from a classic Fangji "Xuefu-Zhuyu Decoction" in an ancient Chinese medical book "Yi Lin Gai Cuo" by Chinese physician Wang Qingren, which is the most representative formula for the treatment of "Qizhi-Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome). XFZY concludes 11 kinds of Chinese herbs: Danggui(Angelica sinensis), Honghua(Safflower Flower), Chishao(Paeoniae Radix Rubra), Shengdihuang(Radix Rehmanniae), Taoren(Peach Seed), Zhike(Fructus Aurantii), Jugeng(Platycodon grandiflorum), Chuanxiong(Rhizome of Chuanxiong), Chaihu(Radix Bupleuri), Chuanniuxi(Cyathula Officinalis),Gancao(liquorice).It is mainly used to treat "Qizhi-Xueyu Zheng", which includes the symptoms such as different types of pain, irritability or depression, insomnia, chest tightness, dark skin, lumps or masses in vitro or in vivo, petechiae on the tongue, and dark purple tongue. The purpose of the trial is to evaluate the efficacy and safety of XFZY in treating "Qizhi-Xueyu Zheng", and investigate the most suitable diseases of XFZY.

Start: December 2019

Contribution of PET (Positron Emission Tomography) Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

Endometriosis is an inflammatory condition that is often treated by surgery. MRI and ultrasound are used for the preoperative morphological assessment. Currently, only surgery allows the exhaustive and qualitative diagnosis of lesions. The PET scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.

Start: June 2021

Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis

Endometriosis is a chronic disease that affects one out of 10 women. Endometriosis care is full of variation. Recommendations for optimal management vary between clinician and centers. One way of dealing with this unwanted variation is the shift towards a value -based endometriosis care. Value-based healthcare (VBHC) is a strategy focused on the optimization of the balance between outcomes that are important to patients and cost to achieve these outcomes. To do so, for a given condition it is important to define a standardized set of outcomes metrics allowing quality of care monitoring and comparison in order to optimize clinical practices and patient pathways. A common set of outcomes combining clinical outcomes (Clinical Reported Outcome Measures, CROMs) as well as quality of life and functional recovery indicators through Patient Reported Outcome Measures (PROMs). Different standardized data sets have already been developed to measure outcomes in other pathologies, however a standardized set of outcome measurements have not yet been determined for endometriosis. The objective of this study is to determine a standard set of outcome measurements for endometriosis.

Start: April 2021

Ovarian Hyperstimulation and Fibrin Clot Properties.

The impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women. Comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility.

Start: November 2019