Endometriosis

This study aims to determine differences in experimental pain and sex hormone levels between patients with migraine, patients with endometriosis, patients with migraine and endometriosis, and healthy controls. Participants will complete surveys, experimental pain paradigms and collection of samples for hormone analyses.

Aim 1. To determine the factors contributing to pain in patients with chronic pelvic pain with and without endometriosis Aim 2. To determine the changes following endometriosis lesion removal surgery in pain and sex hormone levels. Aim 3. To identify factors predicting clinical pain reduction after lesion removal surgery. Additional exploratory aims might compare subgroups of patients such as patients with vs. without endometriosis, with vs. without additional chronic pain syndromes, and with vs. without hormonal treatment. In addition, the role of lesion-specific immune signatures and psychological factors on pain will be explored. Patients with pelvic pain potentially due to endometriosis will complete questionnaires including social, health, behavioral, and psychological questionnaires. Patients will also complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. In addition, blood, urine, and saliva samples will be collected for hormonal, immune, and genetic analyses. Additional samples might be collected and stored for future analyses. For some participants, these procedures will be completed several times, including before the surgery as well as 3 months, 6 months and 1 year after surgery. After the surgery, surveys assessing pain and other symptoms will be sent every week on the first month and then monthly for 1 year. In addition, during the surgery, biopsies will be collected and analyzed to determine hormonal, immune and genetic factors. For adolescents, a parent/legal guardian will be asked to assist in completing some of the health-related surveys (i.e., physical developmental survey, health survey, migraine history survey).

This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program * a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause.

Approximately 1.5 million people in the UK, and 200 million globally live with endometriosis, and it is estimated to affect 1 in 10 women of reproductive age. Endometriosis is a chronic pain condition where the lining of the uterus (endometrium) grows in areas outside the uterus. This can cause patients a range of symptoms including severe pain, fatigue, irregular periods, infertility and gastrointestinal symptoms. There is a clear unmet need for early diagnosis and more effective pain management for people who suffer from endometriosis. Endometriosis is a heterogeneous disease in terms of symptoms, trajectory, and indicated therapeutic course, which highlights the need to develop personalised/targeted approaches for effective longitudinal management which are acceptable and accessible to patients and their health care team. The goal of this study is to accelerate discovery and advance data-driven research into endometriosis diagnosis and treatment by collecting large, multimodal, longitudinal data. To achieve this goal, the investigators plan to deliver a longitudinal cohort study. Approximately 3000 UK individuals with endometriosis will be invited over a 24-month period to self-report symptoms that include, pain, menstrual cycle, painkiller use, sleep, exercise, diet and bowel habits via a bespoke ENDO1000 mobile app. A cohort of 1000 women will be asked to complete more in-depth questionnaires asking about endometriosis history, quality of life and treatments. This cohort of women will be asked to take self-collected biological samples (blood, urine, saliva, vaginal swab and faeces). The investigators will look at, for example, inflammatory markers, examine the microbiome and may look at DNA, with permission to see if there are any markers that can help with diagnosis or treatment of endometriosis. At the same time participants will be asked to wear a smartwatch which will monitor, for example, temperature, ambient light, sleep patterns and movement. All this will help the investigators to build a picture over time of the participant's endometriosis symptoms, treatments and what may cause symptoms to flare which in turn could lead to more patient led treatments.

Endometriosis is a systemic, steroid-dependent, inflammatory disease characterized by the growth of endometrial-like tissue outside the uterus, affecting approximately 10 % of women of childbearing age. The etiology and pathophysiology of endometriosis is not completely understood to support effective treatment and prevention strategies. Despite the steroid dependency, little is known concerning the underlying metabolism of estrogen and other tightly related steroids. Moreover, shortening the long diagnostic delays is a major priority in endometriosis research.

Typical postoperative pain control after minimally invasive hysterectomy includes ibuprofen, acetaminophen, and a short course of narcotics. The purpose of this study is to see if adding cyclobenzaprine to this regime improves pain control and lessens narcotic use.

Endometriosis is a chronic gynecological disease characterized by the presence of endometrial-like tissue outside the uterus and is frequently associated with pelvic pain and infertility. Increasing evidence suggests that immune dysfunction may contribute to the development and persistence of the disease. The purpose of this prospective case-control study is to compare immune cell characteristics in women with deep endometriosis and women without endometriosis during the secretory phase of the menstrual cycle. Participants will undergo collection of clinical data, blood samples, endometrial samples, and vaginal microbiota samples. For participants undergoing clinically indicated pelvic surgery, additional biological samples may be collected during the procedure. The study aims to improve understanding of the immune mechanisms involved in endometriosis and to identify potential biomarkers associated with the disease.

The goal of this investigator-initiated single-site clinical trial is to compare the overall quality of life of participants taking Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis to participants that do not take Rel-CT following the same surgery. Rel-CT is an FDA approved form of medical treatment for endometriosis. It is known to work in treating endometriosis pain. However, investigators do not know whether or not there is a benefit to beginning Rel-CT immediately following surgery. This study will test if patients who take Rel-CT after surgery have better quality of life and less chance the endometriosis comes back, requiring additional surgery. The main question it aims to answer is: \- Does taking Rel-CT following excisional surgery for endometriosis result in higher Endometriosis Health Profile 30 (EHP-30) scores, indicating a positive impact on overall health-related quality of life and well-being? Participants will: * Be randomly assigned to one of two treatment groups. One treatment group will take study drug Rel-CT after having excisional surgery, and the other treatment group will just have the surgery alone. * Be asked to complete questionnaires, called the Endometriosis Health Profile 30 (EHP-30) at 4 timepoints. The first time is before surgery, then at follow-up visits at 1 month, 3 months, and 6 months. The survey has 30 questions that ask about pain, control, powerlessness, emotional well-being, social support, and self-image. Researchers will compare the two treatment groups (Rel-CT and non Rel-CT) to see if there is a change in EHP-30 scores.

Dysmenorrhea affects up to 90% of women of reproductive age and represents a significant public health concern. Beyond prostaglandin-mediated uterine contractions, dysmenorrhea involves central sensitization mechanisms and myofascial components, including abdominal trigger points. Despite growing interest in physiotherapy for chronic pelvic pain, objective data on tissue-level changes induced by manual therapy remain scarce. This randomized single-blind sham-controlled trial aims to evaluate the effects of abdominal manual mobilization techniques on (1) tissue stiffness measured by shear wave elastography at the uterine cervix and bilateral abdominal regions, and (2) clinical outcomes including pain intensity and quality of life in women with dysmenorrhea, with or without endometriosis. Participants will be randomly assigned to either a treatment group receiving standardized abdominal manual therapy or a sham group receiving superficial manual contact. Assessments will be conducted over three menstrual cycles using shear wave elastography, the Numeric Rating Scale (NRS), and the SF-36 questionnaire.

Background: Ovarian endometrioma is the most common manifestation of endometriosis and is associated with chronic pelvic pain, infertility, and reduced ovarian reserve. Surgical treatment options include cystectomy and ablative techniques. Recent evidence suggests that ablative approaches may better preserve ovarian reserve compared with cystectomy while maintaining comparable recurrence and pregnancy rates. However, limited histological data are available regarding the depth of tissue damage induced by ablative techniques and their ability to completely eradicate endometriotic tissue. Objective: This pilot study aims to histologically evaluate the effects of ex vivo ovarian endometrioma ablation using the LEONARDO® DUAL 45 dual-wavelength diode laser (980 nm and 1470 nm). The study will assess the completeness of endometriotic tissue ablation, the depth of laser-induced necrosis within the endometrioma pseudocapsule, and the extent of thermal injury to the surrounding ovarian tissue. Methods: Adult women undergoing laparoscopic surgery for unilateral or bilateral ovarian endometriomas ≥3 cm will be prospectively enrolled. Surgical treatment will consist of cystectomy in reproductive-age women and adnexectomy in selected peri- or postmenopausal women according to routine clinical practice. After surgical excision, ex vivo samples of the internal endometrioma wall will undergo laser ablation using two different laser settings. Histological examination will evaluate residual endometrial glands and stroma, depth of necrosis, and thermal damage to adjacent ovarian tissue. Clinical, surgical, and pathological data will also be collected. Study Design: Prospective, observational, pilot study involving a medical device. Approximately 30 patients will be enrolled, generating multiple histological specimens for analysis. The study is designed to provide preliminary evidence regarding the histological efficacy and tissue effects of dual-wavelength diode laser ablation of ovarian endometriomas.

The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate. Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.

Endometriosis is a disease that affects 1 in 10 women and is associated with debilitating pain and infertility. Endometriosis is where cells similar to those lining the womb (the 'endometrium') grow elsewhere in the body, forming 'lesions'. Most commonly the lesions grow on the lining of the pelvic cavity, called 'peritoneal' endometriosis. Lesions can also grow on the ovary, this is called 'ovarian' endometriosis, or form nodules, called 'deep' endometriosis. At present the only way to confidently identify endometriosis is through surgery, this exposes patient to the risks of surgery and contributes to the diagnostic delay associated with endometriosis. PET/CT is a specialist scan that is commonly used to identify cancers which cannot be seen on other types of scans. PET/CT uses a 'tracer', a substance given into a vein which then temporarily accumulates in areas of disease. This project will determine if a new specialist scan, total body PET/CT, and novel tracers that were developed for other conditions can be used to identify some of the key pathways in endometriosis: bleeding and scarring. Being able to identify these processes in endometriosis lesions and being able to track how they change over time would improve our understanding of endometriosis. The investigators also want to know if these pathways are different between superficial, deep and ovarian endometriosis, and what the impact is of the hormones related to the menstrual cycle. In this study up to 30 people who have suspected endometriosis and are already due to undergo diagnostic surgery will be asked to undergo two total-body PET/CT scans in Edinburgh, one at one visit and one another visit. Participants will also have a PET/MRI scan at visit. Participants will have a different tracer at each visit. The investigators will then compare the scan findings with their subsequent surgical findings.

The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.

The goal of this prospective, multicenter, randomized controlled trial is to compare the clinical efficacy and safety of intra-operative dual laparoscopy and neo-rectoscopy (IDLnR) versus conventional laparoscopy (CL) in patients with bowel endometriosis (BE) undergoing surgery. The primary objective is to assess differences in postoperative bowel function improvement at 6 months between the two groups. The main questions it aims to answer are: Is there a significant difference in postoperative bowel function (primary endpoint) at 6 months postoperatively between IDLnR and CL groups? Do the two groups differ in secondary outcomes, including efficacy indicators (LARS score/cure rate/improvement rate, CRADI-8, Wexner score, GIQLI, EHP-30, VAS pain reduction) and safety indicators (30-day severe complications, antibiotic use intensity, hospital stay \>7 days)? Researchers will randomize BE surgical patients to IDLnR or CL groups, then compare the above primary and secondary endpoints to evaluate IDLnR's clinical value. Participants will undergo either IDLnR or CL surgery for BE lesions, and be followed up to assess bowel function, quality of life, pain, and safety outcomes as specified. This study will fill evidence gaps for IDLnR in BE surgery, support its standardized application, optimize BE treatment strategies, and aim for complete lesion resection, preserved intestinal function, and improved long-term patient quality of life.

The aim of this study is to investigate whether whole-body cryotherapy (a brief exposure to very cold temperatures) can help reduce pain and improve quality of life in people living with endometriosis, and whether it may represent a safe, non-pharmacological approach to managing endometriosis-related symptoms. Up to 30 participants with symptomatic endometriosis (chronic pelvic pain for more than six months) will be recruited over a 12-month period. Participants will attend two study visits at the hospital, approximately four weeks apart. Between these visits, participants will undergo five whole-body cryotherapy sessions, each lasting approximately 3 minutes. During cryotherapy, participants stand in a specialised chamber where the body is briefly exposed to cold, dry air (around -120°C). During the study, will be assessed changes in systemic inflammation and biological markers using blood, saliva, urine, vaginal, and stool samples. Data will be collected using questionnaires evaluating pain and related symptoms, quality of life, sleep, fatigue, intestinal symptoms, and overall wellbeing. The active study phase lasts approximately 4-6 weeks. A final follow-up assessment at 15 weeks will be conducted remotely using questionnaires and self-collected samples.

The purpose of this research study is to study the impact of an educational podcast on pelvic pain. If you decide to take part in this research, you may receive the standard treatment for pelvic pain, or you may receive the standard treatment plus access to an educational podcast series. You will be randomly assigned to receive access to the podcast or to receive standard care. If you are assigned to receive access to the podcast, participating in this research will involve listening to a podcast series. All participants will complete three ten-minute online surveys over the course of 6 months. Reasons you may choose to participate in this research are if you want to learn more about pelvic pain and possible benefits of listening to the podcast, such as improved quality of life, reduced stigma, or increased satisfaction with your medical care.

This randomized, sham-controlled, double-blinded clinical trial aims to investigate the effects of pulsed electromagnetic field therapy (PEMF) on pain intensity, quality of life, and pelvic floor morphometric changes assessed by four-dimensional trans perineal ultrasound (4D TPUS) in women diagnosed with endometriosis. Participants will be randomly allocated into either a PEMF therapy group or a sham PEMF control group. Both groups will continue receiving stable standard medical care throughout the study period. Assessments will be conducted at baseline, after completion of the 8-week intervention period, and at 3-month follow-up.

This is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the pain education program. The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after another 8 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). The initial assessment will include a medical and physiotherapy history, and at T1, T2 and T3 the following will be assessed: pain, abdominopelvic mobility, muscle status, functionality, sexual function, quality of life, stress and biomarkers of chronic inflammation.

The goal of this observational study is to document the lived experiences of self-managing endometriosis in people living with endometriosis who live in Europe. The main question it aims to answer is: \[How\] do support structures across personal, community, healthcare, and institutional levels influence individuals' experiences of empowerment and abandonment in self-managing endometriosis? Participants will describe the everyday actions they take to live with endometriosis, through diary studies, interviews, and focus groups.

The main objective of the study is to assess whether a dietary regimen based on the principles of the FODMAP diet, compared with the current treatment programme which does not include specific dietary recommendations, can improve pain symptoms in patients with symptomatic endometriosis and intestinal symptoms (i.e. bloating, nausea, constipation, diarrhoea and vomiting) attributable to irritable bowel syndrome, compared with a control group

This project PestiEndoMicro aims to provide an innovative approach, studying endometriosis under the genital and gut microbiota scope. To realize this project, the investigators are planning to dose cfDNA to assess the oxidative stress caused by endometriosis and study its epigenetics. At the same time, the investigators will take a pragmatic approach by assessing pesticide exposure in these patients and estimate the correlation between gut or genital dysbiosis and chemical agent exposure. Also, the investigators will take the initiative to use classic culture, qPCR techniques, and NGS to establish signatures in vaginal, endometrial and gut microbiota in patients with endometriosis. With these approaches, the goal is to gain more knowledge about endometriosis and optimize early diagnosis by establishing a signature in the genital and gut microbiota, but also by dosing the cfDNA. By doing so the investigators could open new opportunities to develop new therapeutic strategies for endometriosis.

Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients. This multicenter diagnostic validation study investigates a non-invasive laboratory test for the diagnosis of endometriosis based on the analysis of biomarkers from menstrual blood samples. Study Objective: The primary objective is to evaluate the diagnostic accuracy of a laboratory protocol for biomarker analysis from menstrual blood samples. Performance metrics including Area Under the Curve (AUC), sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) will be assessed by comparing women with confirmed endometriosis to confirmed controls. Study Design: This is a prospective multicenter diagnostic study. Menstrual blood samples are self-collected by participants. Participants: A total of 200 menstruating women aged 14-49 years will be enrolled across study sites. Participants are allocated to one of two cohorts. Study Sites: The study is conducted at multiple gynecological centers in Austria and Germany, with planned expansion to additional sites. Sponsor: Diamens FlexCo, Linz, Austria Expected Study Duration: 3 years

Endometriosis is a chronic inflammatory condition characterized by the presence of endometrium-like tissue outside the uterine cavity. It is estimated to affect approximately 10% of women of reproductive age and it is associated with chronic pelvic pain and infertility, among other symptoms. Endometriosis involves complex changes in the body's cells and immune response. For this reason, the goal of this observational study is to characterize the functional, molecular, and immunological alterations in menstrual blood-derived stem cells (MenSCs) and differentiated decidual stromal cells in women with endometriosis; to validate these findings in endometrial tissue and endometriomas; and to establish their correlation with clinical parameters, with the aim of identifying key pathogenic mechanisms and potential therapeutic targets. The main questions it aims to answer are: * Are there functional and molecular changes in MenSCs from patients with endometriosis compared to healthy volunteers? * Are there any variations in the immune properties of MenSCs throughout the menstrual bleeding period in patients with endometriosis compared to healthy volunteers? * Are these changes also present in endometrial tissue and endometrioma samples? * Can these changes be correlated with clinical parameters in patients with endometriosis? * Can MenSCs serve as a potential therapeutic target for endometriosis? Some participants will be asked to provide menstrual blood on a single day, while others will provide samples during the first five days of menstruation. Additionally, all participants will answer questionnaires about their diet, physical activity, stress, and pain levels. Therefore, the study does not involve the evaluation of a specific intervention on the participants. The results will enable the identification of key altered mechanisms and potential therapeutic targets, thereby contributing to the development of more effective strategies for the diagnosis and treatment of the disease.

Endometriosis is a prevalent gynecological condition affecting approximately 10% of women of reproductive age worldwide. It presents with nonspecific but often severe symptoms, including chronic pelvic pain (in 70% of cases) and infertility (in up to 40% of cases), imposing significant physical, psychological, economic, and societal burdens. Despite its widespread occurrence, the exact etiology and pathogenesis of endometriosis remain unclear, and no definitive cure exists. Early diagnosis and management are crucial for improving patient outcomes; however, major diagnostic delays persist. Current imaging techniques such as transvaginal ultrasound (TVUS) examination and magnetic resonance imaging, along with biochemical markers lack sufficient specificity. Consequently, confirmation of diagnosis still requires surgical procedures under general anesthesia, i.e. laparoscopy ("key-hole surgery") and tissue biopsy. This delay exacerbates the disease burden and healthcare costs, underscoring the urgent need for non-invasive, precise diagnostic strategies. This project proposes a multi-modal approach integrating advanced ultrasound imaging with novel biomarkers identified via comprehensive multi-omics analyses, including proteomics, transcriptomics, and immune profiling, of patient-derived endometrial organoids. It aims to understand the underlying mechanisms of reduced endometrial receptivity of embryos in patients with endometriosis. Additionally, we will explore personalized treatment strategies by utilizing patient-specific organoids for drug screening and evaluation of treatment response. This project aims to develop a non-invasive diagnostic strategy by integrating: 1. AI-enhanced TVUS for improved lesion detection. 2. Multi-omics biomarker discovery through proteomics, transcriptomics, and immune profiling. 3. Underpinning the mechanisms of reduced endometrial receptivity in endometriosis using an in vitro model of embryo-endometrium interaction. 4. Endometrial organoid models to enable precision medicine-based drug testing. The development of a reliable noninvasive or minimally invasive diagnostic test-or a combination of tests-could revolutionize the diagnostic pathway by reducing delays, avoiding the need for surgery, and facilitating disease monitoring and treatment evaluation.