View clinical trials related to Endometriosis.
Filter by:Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC). Ovarian reserve will be measured by the effect on the circulating levels of anti-Mullerian hormone (AMH). Secondary objectives will be effect on pelvic pain, other symptoms, sexual function, quality of life, progression in size of the endometrioma, impact on work productivity and activity impairment, and satisfaction with treatment. Participants will be followed by up to one year.
The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with endometriosis-related pelvic pain. The main question[s] it aims to answer are: - Is PEEPS effective at decreasing pain interference and improving patient-reported quality of life outcomes? - What are the barriers and facilitators to PEEPS implementation? Participants will engage in eight weekly 2-hour sessions led by an endometriosis specialist, pain psychologist, pelvic floor physical therapist, and yoga instructor. At these sessions they will participate in peer support, education, mindfulness, and yoga.
Pelvic pain is considered a symptom of multifactorial origin among which Endometriosis is the main gynecological cause affecting 5-10% of worldwide women in their reproductive years, negatively impacting their quality of life and work efficiency. Treatment of endometriosis-associated pelvic pain is challenging and there are surgical and/or hormonal treatments available with variable endpoints. Gestrinone is a synthetic derivative of 19-nortestosterone with anti-estrogen, anti-progestin, androgenic, and weak estrogen-like action. Previous studies show that the oral treatment with Gestrinone induced an improvement in symptoms associated with endometriosis but with adverse events such as androgenization and uterine bleeding. Parenteral administration of Gestrinone could be effective to treat pain symptoms secondary to endometriosis and minimize these adverse events. This study evaluates the safety and tolerability of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis after 6 months of Gestrinone pellet insertion versus placebo pellet. PK profile of the gestrinone pellet will be monitored.
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.
The role of a single dose of intraoperative clonidine on postoperative opioid requirements, pain intensity and opioid-related side effects in patients undergoing surgical treatment for endometriosis remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative clonidine in patients undergoing surgical treatment for endometriosis is therefore conducted.
Exposure to endocrine-disrupting chemicals can considerably affect female reproductive system. Exposure can occur in living environments and in specific workplaces in which these substances are produced or used. Among endocrinedisrupting chemicals, phthalates, dialkyl esters or alkyl aryl esters of orthophthalic acid (1,2-dicarboxylic acid) represent a group of structurally similar molecules, widely used in industry since 1930 in numerous manufacture processes, mainly as a plasticizer. These substances present dangerous characteristics, particularly associated with reproductive toxicity, and their xenoestrogenicity led some authors to evaluate a possible involvement in the aetiology of endometriosis. In this proposed study the investigators aim to clarify a potential association between endometriosis and phthalates exposure. Women with a diagnosis of endometriosis will be recruited as "cases" while women without endometriosis as "controls". An "ad hoc" questionnaire will be administered to the patient to collect the necessary information on the characteristics of endometriosis as well as their lifestyle and work habits. The biological monitoring will be carried out measuring the urinary levels of phthalate metabolites. In order to produce reliable data and to reduce the possible contamination caused by the contact with plastic materials, samples will be analyzed by High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS). A statistical elaboration of the data will clarify possible identifiable risk factors and associations with specific clinical situations. The investigators expect that women with endometriosis may present higher levels of phthalates compared with women without the disease. In particular, the investigators hypothesize that women with the most severe form of the disease [i.e. deep infiltrating endometriosis (DIE)] may present the highest levels. These study findings will provide valuable suggestions for developing effective strategies to prevent endometriosis.
Endometriosis occurs in about 10-15% of women of childbearing age and is a major cause of infertility and dysmenorrhea. Deep endometriosis is the most serious manifestation of endometriosis, which often affects the quality of life of patients and requires surgical treatment. Detailed description of DE lesions before operation can contribute to treatment planning. However, the detection rate of DE by conventional ultrasound is low, highly dependent on the experience of the examiner and poor reproducibility. Hysterosalpingo-contrast sonography can be used to assess the patency of the fallopian tube but cannot visualize other pelvic structures. Saline-infusion sonoPODography can provide a good acoustic window for pelvic tissue visualization. Therefore, this study is the first to present double contrast-enhanced ultrasound (Hysterosalpingo-contrast sonography and sonoPODography) examination of the pelvic cavity, based on the #Enzian classification system, for preoperative evaluation of DE lesions. The results of laparoscopic surgery were taken as the gold standard to compare the diagnostic efficacy of double contrast-enhanced ultrasound and conventional transvaginal ultrasound in preoperative evaluation of pelvic DE lesions, improving the preoperative diagnosis, reduce the risk of surgery and reduce postoperative recurrence. To compare the diagnostic efficacy of different examination methods in different compartment of DE, and to explore the best examination method suitable for different parts of DE, providing theoretical basis for further early screening and personalized treatment of DE in the future.
Dyspareunia is defined as pain with penetrative sexual intercourse. Women with endometriosis have a nine-fold increased risk of dyspareunia, when compared to the general female population. A prospective single-blinded randomized controlled trial will be performed evaluating the change in pelvic pain and sexual satisfaction scores from baseline to 6 weeks after treatment with transvaginal photobiomodulation therapy or sham therapy. Treatment will involve 9 planned treatment sessions over 3-4 weeks. 40 women will be included in the study.
Endometriosis, vulvodynia, and fibromyalgia are chronic pain conditions that cause great suffering. Despite the significant prevalence of all three conditions, they are receiving relatively little attention in psychological treatment research. Despite the popularity of methods that rely on aggregated group data, such as randomized controlled trials (RCTs), concerns have been raised in recent years about the generalizability of results from these methods to the individual level - group-to-individual generalizability. Since psychological treatments in the clinic are focused on enhancing the well-being of a specific individual this might affect how researchers should study these conditions. The current project aims to investigate: (a) item suitability for daily assessment of psychological variables, (b) group-to-individual generalizability in outcome measures frequently used in psychological studies and treatments of chronic pain, (c) relations over time between process and outcome variables, and (d) possible differences in results obtained across three pain conditions.
The pathogenesis of endometriosis is very complex as several factors, including genetic, environmental and lifestyle-related factors, are involved in the development, progression and maintenance of the disease. In particular, there are emerging evidences that prostaglandin metabolism, chronic inflammatory processes and circulating estrogen levels are involved in the pathogenesis of endometriosis. Pelvic pain, in particular dysmenorrhea, is the most typical symptom caused by the production of prostaglandins and pain mediators associated with the peritoneal inflammatory state. Metabolomics strives to measure all metabolites, such as sugars, amino acids, acylcarnitines, organic acids, and lipids, present in a given biological sample. Thus, metabolomics represents a reflection of phenotypic changes in an organism in response to the presence of a certain disease, genetic changes, and nutritional, toxicological, environmental, and pharmacological influences, providing a means to more accurately capture exogenous exposures and evaluate endogenous biomarkers. Regarding endometriosis, the targeted metabolomics studies focused mainly on lipids, and the non-targeted studies also identified mainly lipids, amino acids, and intermediary metabolites as the most important variables. The combinations of metabolomics data together with clinical ones are of utmost importance in endometriosis research. This approach might lead to the construction of models/algorithms useful to better define diagnostic/prognostic characteristics of women who have endometriosis, identify environmental and modifiable risk factors, elucidate pathogenetic mechanisms, and contribute to better tailor medical treatments. In particular, metabolomics may provide a means to capture exogenous exposures and evaluate endogenous biomarkers more accurately. The main objective of the present research project is to evaluate potential variations in the plasma metabolomic profile of women affected by endometriosis (as compared with a control group) as a consequence of pathophysiologic alterations associated with this disorder. Secondary objectives are: 1. to evaluate potential variations in the plasma metabolomic profile of endometriosis patients with different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis; 2. to evaluate potential variations in the plasma metabolomic profile of endometriosis patients in relation to the presence of endometriosis-related painful symptoms and/or infertility. There is strong evidence that endometriosis has a negative impact on women's quality of life, with severe long-term consequences and substantial social costs. Our findings might lead to the construction of models/algorithms useful to better define diagnostic/prognostic characteristics of women who have endometriosis, identify environmental and modifiable risk factors, elucidate pathogenetic mechanisms, and contribute to better tailoring medical treatments.