Clinical Research Directory

Evaluating the Feasibility of elleFA App Implementation

Endometriosis is a chronic incurable disease where endometrial-like tissue grows outside of the uterus, and causes symptoms such as debilitating menstrual pain, pain during intercourse, infertility, constipation, and bloating, which hurts their quality of life. Endometriosis is estimated to affect approximately 10% of women. Despite this, there's currently not enough research on this disease; in Canada it takes on average 5.4 years to get a diagnosis (from when symptoms start), and once diagnosed, women often have to go through a trial-and-error process to find a treatment that can manage their symptoms. Misunderstanding symptoms and struggling with patient-provider communication both contribute to these delays in diagnosis and finding the best treatment. Mobile health applications have been a promising new tool to self-track symptoms and treatments. There are several apps currently available on the market for logging chronic pain, menstrual cycles, and fertility. However, no apps exist specifically for endometriosis that look at the whole spectrum of symptoms, including pain, quality of life, and especially ease of patient-provider communication. The elleFA app is a new, personal endometriosis and health tracking app designed to improve patient-physician dialogue through more direct, efficient, and impactful communication, as patients navigate their condition. This single-arm interventional study aims to test the feasibility of implementing the new elleFA app in a clinical setting for 6 months in pre-menopausal women 18 years and older with endometriosis, and the app's impact on patient experience. Participants will download the elleFA app on their smartphone and will be asked to complete two questionnaires through the app every month for 6 months. Participants can choose to also optionally track their daily symptoms, lifestyle, and treatments, through weekly symptom log summaries through the app. The main study finding will be be patient adherence to using the app over a 6 month study period. Other findings will include user-reported satisfaction with the elleFA app, and the impact of elleFA app use on patient experience communicating with their healthcare team.

Physical Therapy After Endometriosis Excision

This is a randomized controlled pilot study comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Quality of life and endometriosis symptoms will be compared following the recovery period.

Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

The goal of this randomized controlled trial is to assess whether a 12-week anti-inflammatory diet can improve fertility outcomes in women with endometriosis undergoing In Vitro Fertilization (IVF). The main questions are: * Does the anti-inflammatory diet reduce the rate of inadequate ovarian response to hormonal stimulation (retrieval of ≤3 oocytes)? * Does it improve secondary outcomes such as embryo quality, pregnancy rates, inflammation markers, and quality of life? Researchers will compare two groups: * Women receiving standard IVF protocols. * Women undergoing the same IVF protocol plus the anti-inflammatory diet. Participants will: * Be randomized into one of the two groups. * Follow dietary counseling sessions and complete dietary assessments (diet group). * Provide biological samples (e.g., plasma, vaginal and fecal swabs, and follicular fluid) before and after the dietary intervention to evaluate potential differences in inflammation, hormonal levels, and microbiome composition between the two groups and across timepoints (pre- and post-diet). * Complete questionnaires on quality of life, sexual function, and symptomatology severity before and after the intervention to assess differences between the two groups and across timepoints.

Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis

The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate. We will check how the body absorbs and responds to each medicine, monitor possible side effects and treatment benefits. Researchers will compare HHK001 to Enantone to test the advantages of its updated formulation.

Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy

The aim of the present study is to compare two types of psychotherapeutic interventions in women with endometriosis and/or adenomyosis: cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). The study will examine whether these therapies differ in their effects on health-related quality of life. It will include women with a recent diagnosis and women who have been living with the diagnosis for a longer time. The main questions are: * Do CBT and ACT differ in their effects on health-related quality of life? * Do the two therapies differ in their effects on pain-related difficulties, emotional well-being, fatigue, sexual functioning, and other aspects of daily life? Participants will be randomly assigned to receive either CBT or ACT. Both groups will attend eight therapy sessions, held every two weeks. Participants will complete online questionnaires before treatment, after session 4, after treatment, and 3 and 6 months after treatment. The questionnaires will assess quality of life, pain, emotional well-being, and other aspects of health and daily functioning. The study will take place at the Endometriosis Centre of Careggi University Hospital in Florence, Italy. Eligible participants must be women aged 18 or older who are receiving care at this centre and have a confirmed diagnosis of endometriosis and/or adenomyosis based on medical assessment. They must have been on stable medication treatment for at least 3 months, speak and write Italian fluently, have internet access, and be able to provide informed consent. Women with a current psychiatric diagnosis or who are currently receiving psychotherapy are not eligible to participate in the study.

Pelvic Pain in Women With Endometriosis

This study will examine pelvic pain associated with endometriosis and explore better approaches to treatment. In women with endometriosis, uterine tissue grows outside the uterus. Standard treatments - altering hormone levels to prevent endometrial tissue growth or surgically removing endometrial tissue - treat pelvic pain only temporarily. This study will investigate the role of sex hormones, immune chemicals, stress hormones, and genes in pelvic pain and determine how the nerve, muscle, and skeletal systems are involved in this pain. Women between 18 and 50 years of age who: 1. have endometriosis and chronic pelvic pain, and 2. have chronic pelvic pain without endometriosis, and 3. have neither endometriosis nor chronic pelvic pain and are willing to have a tubal ligation (Healthy Volunteer group), may be eligible for this study. Candidates are screened with a questionnaire to obtain information about their pain and previous treatments and related medical or social issues. Participants will undergo the following tests and procedures: 1. Medical history and physical examination, including pelvic exam, blood tests, urinalysis, and diaphragm fitting. 2. Questionnaires about pain, quality of life, sexuality, psychological attitudes, spiritual experiences, and history of headache and depression. 3. At-home monitoring for 4 to 6 weeks of pain symptoms, menstruation and spotting, medicines taken, and urine collections to test for "LH" surge. LH is the hormone that causes the ovary to release a mature egg. 4. Pre-laparoscopy evaluation to include: * Examination of menstrual blood collected in a diaphragm for 4 hours. * Blood sampling to measure adrenal and pituitary hormones. For this test, corticotrophin-releasing hormone (CRH) is injected through an IV needle. Up to five blood samples are drawn, starting before the injection until 45 minutes after it. Blood is also collected at this time for genetic analysis. * In-depth pain assessment to identify trigger points in muscles associated with pelvic pain, regions of skin sensitivity, and bone pain. Some women will undergo microdialysis, which uses an acupuncture-type needle to collect chemicals from two different muscles. * Blood sampling twice a week for 1 month to measure changes in blood substances during the menstrual cycle. * Blood sampling after the LH surge to measure progesterone levels. * Cervicovaginal lavage (washing of the cervix with saline and collecting the fluid) to obtain secretions for research. * Ultrasound of the ovaries and uterus. This examination uses a probe inserted into the vagina that emits sound waves that are used to form pictures of the internal structures. A small piece of uterine lining is also obtained for examination and research purposes. * A visit with the members of the Pain and Palliative care service to evaluate the pain in anticipation of offering other treatments for pain after surgery. * Surgery: CPP + Endo or CPP only: Laparoscopy to look for and remove endometrial tissue. This procedure is done under general anesthetic. A viewing instrument called a laparoscope is passed through an incision in the belly button to look for endometriosis. If it is found, two or more incisions are made in the abdomen for other instruments to remove the tissue. A small piece of uterine lining is also obtained for examination and research purposes. Healthy Volunteers: Laparoscopy to perform the tubal ligation. A tubal ligation, commonly known as "getting your tubes tied," is a surgical procedure for women to sterilize them. This procedure closes the fallopian tubes, stopping the egg from traveling from the ovary to the uterus and preventing sperm from reaching the fallopian tube to fertilize an egg. In a tubal ligation, fallopian tubes are cut, burned, or blocked with rings, bands or clips. The surgery is effective immediately. Tubal ligations are 99.5% effective as birth control. This procedure is done under general anesthetic. A viewing instrument called a laparoscope is passed through an incision in the belly button to perform a tubal ligation. Two or more incisions are made in the abdomen for other instruments to perform the procedure. During the laparoscopy, we will look for and remove endometrial tissue. A small piece of uterine lining is also obtained for examination and research purposes. -Follow-up evaluations. Two weeks after surgery, patients return to NIH to discuss the surgical findings and treatment options. Follow-up visits are then scheduled at 1, 3, and 6 months after surgery to complete questionnaires and determine if the treatment is working. Blood samples are drawn at each visit.

Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)

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

Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis

This retrospective single-centre study evaluates how accurately preoperative ultrasound detects bowel involvement in women with deep endometriosis, using surgical findings as the reference. It also assesses whether ultrasound correctly locates and measures bowel lesions, and whether ultrasound lesion size predicts the type of bowel surgery performed (shaving, discoid excision or segmental resection). Data come from the medical records of patients operated at the Endometriosis Clinic of Hôpital Erasme, Brussels.

Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis

The goal of this clinical trial is to learn how ashwagandha, a herbal dietary supplement, affects quality of life in women with endometriosis. Researchers will also assess how well participants tolerate it. The main questions are: * Does ashwagandha affect mental well-being and quality of life compared with placebo? * Does it affect physical health, perceived stress, or endometriosis-related quality of life? * Does it affect pain during intercourse or how participants manage pain, including pain medication use? * What side effects or changes in blood test results occur during supplementation? Researchers will compare ashwagandha with a placebo, a look-alike capsule containing no active ingredient. The study will include 90 women. A chance process will assign participants to a group. Each participant has a two-in-three chance of receiving ashwagandha. Neither participants nor researchers assessing the results will know who receives ashwagandha during this phase. Participants will: * Take 300 mg of ashwagandha or placebo daily for 12 weeks. This may extend to 16 weeks to match assessments with the menstrual cycle. * Complete questionnaires about quality of life, stress, pain during intercourse, and pain management. * Attend regular clinic visits for health checks and blood tests. * Attend a follow-up visit about four weeks after finishing the study capsules. After the first phase, eligible participants may choose to continue for another 12 weeks. Everyone in this optional phase will take ashwagandha and know they are taking it. Researchers will track further changes in quality of life, stress, and side effects. Participants will continue their usual care for endometriosis. Whether ashwagandha benefits women with endometriosis is not yet known.

Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis

This study is a double-blind, randomized, placebo-controlled study that evaluates the safety and tolerability of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks. The primary objective is to evaluate the safety and tolerability of the supplement, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fibers impact on gastrointestinal symptoms and quality of life through the use of custom questionnaires built for the study population and evaluation of other endometriosis related parameters such as pelvic discomfort. Exploratory objectives focus on the exploration of the gut and vaginal microbiomes, their connection to endometriosis, and how they are impacted by the study product.

Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.

Retinal Imaging for Systemic Inflammation in Endometriosis

There is increasing evidence that examining our eyes can tell us a lot of information about our health, and systemic diseases. Our plan is to compare the images taken of the back of eyes of women who have endometriosis with those of women who don't. We want to study what eyes can reveal about endometriosis by analyzing the retinal images from a simple noninvasive eye scan, that is already being routinely used to provide immediate clinical information in other groups of patients (eg. diabetic eye screening).

Postoperative Pain Trajectories After Endometriosis Surgery

The pain associated with endometriosis reflects a multifactorial pathophysiology combining peripheral nociception, central sensitisation and psychosocial factors. Although surgery is an integral part of treatment, a significant proportion of patients experience persistent pain several months after the procedure. To date, postoperative pain trajectories after endometriosis surgery remain poorly characterised, and there are no reliable predictors of chronic postoperative pain (CPP). This prospective, single-centre, longitudinal study aims to identify distinct postoperative pain trajectories and to assess whether perioperative quantitative sensory testing can predict the development of chronic postoperative pain at 3 and 6 months. Patients will undergo perioperative mechanical and pressure tests, including assessment of temporal summation and pressure pain thresholds, combined with validated measures of patient- reported outcomes. Follow-up assessments will be conducted on day 2, day 14, 1 month, 3 months, and 6 months after surgery to capture the dynamic evolution of pain, quality of life, fatigue, sexual function, and central sensitisation symptoms.

Nutritional Intervention for Endometriosis

In a 12-week parallel study, women with a verified diagnosis of endometriosis will be randomly assigned to follow a low-fat plant-based diet or to stay on their usual diets for 12 weeks. Participants in both groups will be asked to make no changes to their exercise patterns for the study period. Changes in pain, quality of life, and inflammatory biomarkers from baseline to final will be the primary outcomes. Secondary outcomes will include changes in body weight, blood lipids, gut microbiome composition, and hormonal changes.

A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis

The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).

Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis

This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.

Perioperative Esketamine Safety and Efficacy in Reducing Postoperative ENDometriosis PAIN (the ENDPAIN Trial): a Randomized Controlled Trial.

Endometriosis is a chronic condition affecting approximately 10% of women. It is frequently associated with persistent or recurrent pelvic and abdominal pain. The mechanisms underlying pain in endometriosis are complex and may include direct stimulation from endometriotic lesions and local inflammation, nerve involvement, and alterations in central pain processing. In some individuals, sensitization of the nervous system may result in pain persisting despite limited ongoing tissue injury. Surgery is an important treatment option for patients whose symptoms are insufficiently controlled by medical therapy or in whom surgery is indicated to improve fertility. The primary aim of surgery is to remove endometriosis lesions, thereby reducing symptoms and improving quality of life. However, patients undergoing surgery for endometriosis often experience more severe postoperative pain and require greater opioid consumption than patients undergoing other gynecological procedures. They may also be at increased risk of developing persistent postoperative pain, defined as pain that continues beyond the expected healing period and persists for months after surgery. Esketamine is a well-established medication used in anesthesia and pain management. Its pharmacological effects and safety profile are well characterized. It is commonly administered in patients with pre-existing pain conditions or chronic opioid use. Previous studies suggest that esketamine may reduce acute postoperative pain, decrease opioid requirements, and provide benefits in certain neuropathic and chronic pain conditions. However, its efficacy and safety have not been systematically evaluated in patients undergoing surgery for endometriosis. The ENDPAIN trial aims to evaluate the efficacy and safety of perioperative esketamine in patients undergoing surgery for endometriosis, with the goal of improving postoperative pain management and recovery. Primary Objective: To evaluate the efficacy and safety of perioperative esketamine in reducing postoperative pain in patients undergoing intra-abdominal surgery for endometriosis. Secondary Objectives: To collect information on preoperative and postoperative pain in patients undergoing surgery for endometriosis in order to improve understanding of the mechanisms and risk factors associated with severe acute postoperative pain and persistent postoperative pain. To collect information on the effects of other analgesic medications used as part of routine clinical care in participating centres and to explore potential interactions between these medications and esketamine. Primary Endpoint: Postoperative pain measured using a Numerical Rating Scale (NRS) at 30 minutes, and at 6, 12, 24, and 48 hours after surgery. Secondary Endpoints: Hospital-free days within 30 days after surgery, defined as the number of days spent alive and outside an acute-care hospital during the first 30 postoperative days. Opioid consumption during the first 48 postoperative hours. Quality of Recovery (QoR-15) score. Serious adverse events. Adverse reactions associated with esketamine, including hypertension, tachycardia, hallucinations or dissociative symptoms, sedation, nausea, and vomiting. Persistent postoperative pain and other patient-reported outcomes assessed three months after surgery. Trial Design: The ENDPAIN trial is a triple-blinded, randomized, placebo-controlled clinical trial with a follow-up duration of three months. Participants will be enrolled on the day of surgery. Most study data will be collected during the first 48 postoperative hours. A follow-up assessment will be conducted three months after surgery and may take place either during a study visit or by telephone, according to participant preference and local site procedures. Trial Population: Adult patients undergoing elective surgery for endometriosis will be eligible for inclusion. Patients will be excluded if they: Do not provide informed consent. Have a known hypersensitivity or allergy to esketamine. Have a current or previous history of ketamine or esketamine misuse. Have a medical condition in which esketamine is contraindicated, such as elevated intracranial or intraocular pressure. Have severe systemic disease (ASA Physical Status \> III). Have severe psychiatric illness. Intervention: Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. Participants allocated to the intervention group will receive esketamine 0.5 mg/kg following induction of anesthesia, followed by a continuous infusion of 0.15 mg/kg/hour until approximately 20 minutes before skin closure. Participants allocated to the control group will receive an equivalent volume of placebo consisting of sodium chloride solution (saline).

Prospective Trial of [18F]AlF-FAPI-74 for PET Imaging of Fibroblast Activation Protein in Patients With Endometriosis

The goal of this clinical trial is to learn whether \[18F\]AlF-FAPI-74 PET/CT can help detect endometriosis in adult women who are already scheduled for laparoscopy due to suspicion of deep infiltrating endometriosis or superficial peritoneal endometriosis. The main aims are: (i) How well does \[18F\]AlF-FAPI-74 PET/CT identify endometriosis lesions compared with findings during laparoscopy? (ii) Can PET/CT identify additional lesions that may not be seen on ultrasound or MRI? (iii) Can ultra-high-resolution NeuroEXPLORER PET/CT improve the detection of small lesions compared with standard PET/CT? Participants will: (i) Receive an intravenous injection of \[18F\]AlF-FAPI-74 followed by a PET/CT scan before their planned laparoscopy. (ii) Undergo their planned laparoscopy, during which PET findings will be compared with the surgical findings and where tissue is removed with laboratory analysis. (iii) Optionally undergo an additional NeuroEXPLORER PET/CT scan after the same tracer injection. (iv) Optionally undergo a second \[18F\]AlF-FAPI-74 PET/CT if participants started gonadotropin-releasing hormone (GnRH) treatment after their first scan to investigate whether tracer uptake in endometriosis lesions changes during treatment.

Cardiovascular Disease Risk in Women With Endometriosis

To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance

This study will test the hypothesis that the molecular changes present in ectopic endometriosis lesions correlate with progesterone-resistant disease (using the criteria defined in this study) and are present in matched eutopic endometrium.

Experiences and Care Pathways Shared on Social Media Regarding 5 Conditions Causing Chronic Pain

Chronic pain is a major symptom shared by several medical conditions. This study focuses on five well-defined chronic diseases : Lyme Borreliosis (LB), Post-Acute COVID-19 Syndrome (PACS or "long COVID"), fibromyalgia, endometriosis, and rheumatoid arthritis. Although all of these conditions are associated with chronic pain, they differ in several important aspects, justifying their choice for a comparison. The overall objective of this study was to describe the symptoms, treatments, and healthcare pathways associated with these five conditions, as reported by patients on social media platforms and online forums. The specific objectives were to compare PTLDS with the four other conditions across the following aspects: (i) Incompatible symptoms reported by patients; (ii) Different components of pain : physical, emotional, and social; (iii) Healthcare pathways; and (iv) Adherence to treatment recommendations.

Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy

The study is a prospective, monocentric, randomized controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany. In this Post Market Study it will be determined whether and to what extent the two surgical procedures for ovarian endometrioma treatment (standard cystectomy versus APC) may affect the ovarian reserve by comparing changes in serum AMH levels after treatment. Seventy-two (72) patients who meet all eligibility criteria will undergo surgical procedure. The patients will be randomized into the group with standard cystectomy treatment or with APC treatment. Per group n=36 patients will be treated i.e., 1:1 randomization. A pre-specified primary endpoint analysis is planned after the last patient has undergo Visit 4 (Follow-up after 6 months) to analyze the primary endpoint. Screening takes place during the first visit (V1). During the second visit (V2) the participants will receive the ovarian endometriosis treatment procedure either with the APC or the standard cystectomy. Standard procedure (standard cystectomy) will be performed for additional endometriosis lesions. The follow up visits (V3 - V5) will take place after three, six and twelve months. Visit 3 and Visit 4 will take place at the study site and AMH will be measured. Whereas Visit 5 will take place via telemedical contact, i.e. phone call.

The Impact of Yoga on Endometriosis-Related Pain

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.

Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery

Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and identifying an effective, safe, economical, and broadly applicable intervention strategy that may facilitate emergence from anesthesia, accelerate postoperative recovery, shorten the length of hospital stay, and reduce hospitalization costs. This trial aims to determine whether preoperative stellate ganglion block (SGB) and intraoperative intravenous dexmedetomidine (DEX) can improve postoperative sleep quality in patients undergoing laparoscopic gynecologic surgery, and whether the combination of these two interventions provides an interaction effect or additional ben