Clinical Research Directory

Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis. Participants: A total of 24 participants will be recruited from individuals with clinically suspected endometriosis. Procedures (methods): This is a prospective, one arm, single center study of 24 subjects with clinically suspected endometriosis to demonstrate FFNP PET-MRI's clinical utility for diagnosis of endometriosis.

Effect of Yoga on Pelvic Pain and Quality of Life in Endometriosis

Women may experience loss of work/education and disruption in family relationships due to endometriosis-related symptoms. While surgical and medical treatments provide effective results in the management of endometriosis-related pain, the rate of recurrence is high. There is a need for nurse-led studies to identify supportive practices and interventions that can improve the quality of life and comfort of women with endometriosis, as well as to assess the effectiveness of these interventions. Nurses, with their holistic and patient-centered approach, play a crucial role. Therapeutic communication between nurses and patients during the diagnosis, treatment, and follow-up of endometriosis will contribute to disease management. While there are limited studies worldwide examining the effects of yoga on pain and quality of life in women with endometriosis, no studies have been found in our country on the effectiveness of yoga on endometriosis. Therefore, this study was designed to contribute to the literature and evaluate the effects of yoga on pelvic pain and quality of life in women with endometriosis.

Study on the Outcomes of Patients Treated in Gynecological Emergency Departments for Pelvic Endometriosis or Suspected Pelvic Endometriosis

Adult patients consulting the gynecological emergency department of CHI Créteil during the inclusion period for endometriosis or symptoms suggestive of endometriosis

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.

Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas

The objective of this study is to evaluate the effect of laparoscopic sclerotherapy on ovarian reserve and its overall efficacy in the treatment of endometriomas. Ovarian reserve will be assessed using preoperative and postoperative anti-Müllerian hormone (AMH) levels and antral follicle count (AFC). Traditionally, ovarian endometriomas are managed by complete cystectomy; however, multiple studies including a large systematic review and meta-analysis-have demonstrated that cystectomy significantly reduces ovarian reserve, with an average decline in AMH of 1.77 ng/mL within one to six weeks postoperatively without recovery to baseline after many months. Sclerotherapy has historically been a potential alternative, typically performed by interventional radiology via transvaginal, transabdominal, or transgluteal drainage. This percutaneous approach, however, precludes direct visualization of the cyst and surgical management of concurrent conditions including endometriosis peritoneal disease, excision, adhesions, or tubal disease. Several studies have explored the feasibility and effectiveness of laparoscopic sclerotherapy, reporting encouraging results regarding its safety, increased AFC compared with cystectomy, and comparable pregnancy rates. Nonetheless, none of these studies have been conducted in the United States, and few have utilized a laparoscopic approach. Further research is therefore warranted to establish the accessibility and reproducibility of this technique. The investigators aim to conduct the first U.S.-based study evaluating the impact of laparoscopic sclerotherapy on ovarian reserve. The primary outcome will be the change in AMH and AFC at six weeks postoperatively. Consistent with prior evidence, the investigators hypothesize that laparoscopic sclerotherapy will result in a smaller decline in ovarian reserve compared with traditional cystectomy.

Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function

Endometriosis is a chronic estrogen-dependent disease characterized by the presence and growth of endometrium-like tissue outside the uterine cavity. This ectopic endometrial tissue induces a chronic local and systemic inflammatory response, resulting in the most common manifestations of the disease: chronic pelvic pain, infertility, and pelvic adhesions. In deep endometriosis (DE), adhesions and infiltrative growth may damage adjacent organs. Overall, endometriosis affects approximately 10% of women of reproductive age. Its prevalence is higher among women with infertility (20-50%) and among patients with chronic pelvic pain (up to 90%). The disease is usually categorized as superficial peritoneal, ovarian, or deep endometriosis (DE). Deep endometriosis is a progressive form of the disease that may affect organs beyond the pelvic cavity, including the urinary tract, alter their anatomy, and cause functional impairment. Urogenital involvement occurs in approximately 1-5.5% of all women with endometriosis; the prevalence is substantially higher among patients with DE, reaching 16-53% according to the available literature. Within the urinary tract, the bladder is most commonly affected (70-85%), followed by the ureters (9-23%), kidneys (approximately 4%), and urethra (approximately 2%). Ureteral endometriosis is therefore a relatively rare but clinically significant entity. It may be unilateral or bilateral, with a predominance of left-sided involvement. Two basic forms are distinguished: * "Extrinsic" - ureteral stenosis caused by periureteral fibrosis and the presence of DE lesions without infiltration of the ureteral wall. * "Intrinsic" - ureteral stenosis caused by direct infiltration of the ureteral wall by endometriotic tissue. Ureteral stenosis causes secondary hydronephrosis and, unless treated in a timely manner, may lead to a progressive loss of renal function. The disease frequently remains asymptomatic for a prolonged period. Up to half of cases are diagnosed incidentally or only at an advanced stage, when renal damage is already irreversible. Early detection and timely planning of surgical management are therefore essential for preserving renal function. The main surgical procedures are: * ureterolysis - release of the ureter from fibrotic adhesions, preferred for the extrinsic form; * ureteroneocystostomy (UCNA) - indicated for the intrinsic form when the affected segment must be resected and the ureter reimplanted into the bladder; * ureteroureterostomy (ureteral anastomosis) - appropriate for the intrinsic form when, following resection, the distal ureteral segment is sufficiently long to allow anastomosis of healthy margins. Despite the clinical significance of the condition, prospective studies objectively evaluating the evolution of renal function after the individual types of surgical management of ureteral endometriosis are still lacking. A modern diagnostic strategy combining specialized ultrasound, dynamic renal scintigraphy (MAG3), and analysis of urinary biomarkers of tubular injury (KIM-1, CCL-2, L-FABP) enables earlier detection of renal dysfunction and more accurate monitoring of postoperative recovery. Identification of sensitive biomarkers of early renal injury and validation of an algorithm for their use could substantially improve decisions regarding the timing of surgery and subsequent postoperative follow-up. Based on our experience, some patients surgically treated for hydronephrosis caused by DE-related ureteral stenosis show persistent morphological changes on renal ultrasound and the manifestation of systemic conditions such as arterial hypertension during long-term follow-up. To date, no study has focused on the long-term follow-up of patients with ureteral DE and its potential consequences. The expected benefit of this study is to establish clear criteria for the indication of surgical treatment of ureteral endometriosis and to develop an evidence-based protocol for long-term follow-up.

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.

The Women's Health Study: From Adolescence to Adulthood

In order to learn more about women's health issues that occur over the lifespan, the Women's Health Study: from Adolescence to Adulthood is building a biorepository and database. The biorepository collects, processes and stores samples (such as urine, saliva, blood, cells, tissue and peritoneal fluid) until they are needed for research. The database contains de-identified information about our study participants. The biorepository and database are being created to serve as a resource for researchers from Boston Children's Hospital, Brigham and Women's Hospital and outside institutions.

Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI

This prospective study targets infertile women with endometriosis (EM) who have experienced a previously failed Intracytoplasmic Sperm Injection (ICSI) trial. Using the P-I-C-O framework, the study evaluates whether the administration of an anti-TNF-α therapy (Intervention) 4-5 days before a frozen blastocyst transfer (FBT) improves reproductive outcomes compared to standard protocols (Comparison). The primary outcome is the clinical pregnancy rate, with secondary outcomes focusing on implantation, ongoing pregnancy, and neonatal health. The goal is to determine if mitigating pro-inflammatory cytokines like TNF-α can enhance endometrial receptivity in this specific high-risk population.

Endoexpedition - Use of a Serious Game to Deliver Patient Information and Decision Aid for Individuals With Endometriosis.

Endometriosis is a chronic disease that can negatively affect quality of life, daily functioning, fertility, and psychological well-being. Adequate patient education is important for informed decision-making and active participation in care, but traditional written information may not meet the needs of all patients. This national multicenter randomized controlled trial will evaluate whether a serious game can improve patient satisfaction when delivering information about endometriosis and its treatment options compared with standard written information. Adults with suspected or confirmed endometriosis will be randomized to receive either game-based educational material (Endoexpedition) or traditional written information. The study will assess patient satisfaction, knowledge acquisition, engagement, knowledge retention, and user interaction with the educational platform. A total of 250 participants will be included and followed for up to one year.

Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-associated Pain

A phase 3 study to evaluate the efficacy and safety of HMI-115 in women with moderate to severe endometriosis-associated pain over a 24-week treatment period and a 28-week extension

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.

Guangdong Provincial Endometriosis Clinical Research Cohort

Endometriosis is a chronic condition that may cause pelvic pain, ovarian cysts, infertility, and recurrent symptoms. This prospective observational cohort study will enroll women aged 18 to 45 years with endometriosis and age- and body mass index-matched healthy women. Participants will receive routine clinical care, and the study will not assign medications or procedures. Baseline clinical information will be collected, and participants will be followed for 24 months, every 3 months during the first year and every 6 months thereafter. The study will assess cyst recurrence, pain recurrence, pregnancy and live birth outcomes, and other long-term clinical outcomes. It will also evaluate associations between disease characteristics, rASRM stage, routine medical treatment, and subsequent clinical and reproductive outcomes, and will support the establishment of an endometriosis clinical research database.

Use of TENS Unit in the Management of Endometriosis Pain

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.

Biomarkers for Endometriosis

Endometriosis is a condition in which tissue similar to the lining of the uterus grows outside the uterus, often causing pain and infertility. Currently, endometriosis can only be definitively diagnosed through invasive procedures like laparoscopy and biopsy. The purpose of this study is to investigate whether the proteins Synuclein Gamma (SNCG) and B-Cell Lymphoma 6 (BCL6), measurable in blood and menstrual fluid, can serve as non-invasive biomarkers to diagnose or monitor endometriosis.

Impact of Educational Videos on Pre-operative Anxiety

The goal of this clinical trial is to learn if educational videos can reduce pre-operative anxiety in patients undergoing minimally invasive gynecologic surgery. The main question it aims to answer are: do patient education videos decrease preoperative anxiety? do patient education videos increase patient preparedness for surgery? Researchers will compare the group who watched the videos preoperatively to the group who only underwent the usual counseling at the preoperative visit to see if the results of a survey that measures anxiety and preparedness differ. Participants will be randomly assigned to one of two groups: one group that will be asked to watch the educational videos and one group that will not. All participants will attend their pre-operative appointment as usual and complete a survey afterwards.

Improving Access to Pelvic Health Physiotherapy for Endometriosis

This is a mixed-methods study aimed to generate new evidence to help optimize access to pelvic health physiotherapy (PHPT) for women living with endometriosis in the province of Quebec (Canada). Specifically, the objectives are to: Obj. 1: Understand the patient journey of women living with endometriosis, including their experiences accessing PHPT. Obj. 2: Describe current PHPT clinical practices and service delivery for women living with endometriosis in Quebec. Obj. 3: Identify barriers, facilitators and potential strategies to improve access to PHPT services and optimize the patient journey of women living with endometriosis in Quebec. Findings will inform clinical, organizational and policy recommendations to strengthen the integration of PHPT within multidisciplinary endometriosis care. The project is divided into three sequential parts: Part 1: Semi-structured individual interviews (open-ended questions) will be conducted with women living with endometriosis to explore their journey to obtain endometriosis care, experiences accessing PHPT and perceived barriers and facilitators. Approximately 15-20 participants will be recruited until data saturation is reached. Part 2: An online cross-sectional survey will be conducted among pelvic health physiotherapists practicing in the province of Quebec, Canada to describe current clinical practices, service delivery and challenges related to the management of women living with endometriosis. The minimum expected sample size is 225 physiotherapists . Part 3: Semi-structured focus groups (open-ended questions) will be conducted with women living with endometriosis, pelvic health physiotherapists, physicians and healthcare managers to identify and prioritize strategies to improve access to PHPT services. Approximately 24-32 participants will be recruited across four focus groups. Across all three parts, recruitment strategies will aim to ensure diversity in participant characteristics, including geographic region, sociodemographic characteristics and healthcare experiences, to capture a broad range of perspectives.

Pelvic Floor Physical Therapy and Exercise for Women With Endometriosis and Chronic Pelvic Pain

Endometriosis is a chronic gynecological condition that can cause persistent pelvic pain, painful menstruation, painful sexual intercourse, and reduced quality of life. This study will evaluate whether specialized pelvic floor physical therapy combined with a structured physical exercise program is more effective than a placebo intervention combined with the same exercise program in reducing chronic pelvic pain in women with endometriosis. Participants will be randomly assigned to one of the two groups and followed for 12 weeks.

Effect of Tele-Yoga on Pain, Fatigue, and Quality of Life in Endometriosis

This study aims to examine the effects of Tele-yoga on chronic pelvic pain, fatigue, and quality of life in patients diagnosed with endometriosis. It will be conducted as a single-center, randomized controlled experimental study design.

Identify a Specific Immune Profile in Patients With Chronic Pelvic Pain Resistant to First-line Treatments by Measuring Th1, Th2, Th17, and Treg Cytokines Produced After Non-specific Functional Cell Stimulation - ImmunoCPP

Chronic pelvic pain (CPP) affects more than one in four women. An immune imbalance in the Th1/Th2 balance has been reported in multiple CPP situations, particularly in patients with endometriosis, but with mixed results. The use of a functional immune test, already validated in previous indications and particularly in infertility, could simulate an immune stimulation similar to that of painful attacks.

Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain

Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. A variety of medical cannabis and hemp-derived products on the marketplace claim to hold efficacy for many womens health-related conditions, including gynecologic pain. This 7-day study of individuals living with endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID), will identify specific targets and mechanisms underlying the potential impact of a hemp-derived, full-spectrum, high-CBD product in individuals with gynecologic pain.

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Purpose: To determine the effects of SERM and simvastatin interventions on endothelial dysfunction in women with endometriosis. Hypothesis: Treatment with the SERM (bazedoxifene + conjugated estrogen) or with simvastatin will decrease systemic inflammation and improve specific measures of cardiovascular function including endothelium-dependent vasodilation.

Thromboxane Function in Women With Endometriosis

The goal of this clinical trial is to compare neurovascular regulation in women with endometriosis and healthy women. The main questions it aims to answer are: * Do women with endometriosis have greater blood pressure and pain responses to a stimulus than healthy women? * Do women with endometriosis have greater platelet activity than healthy women? Participants will take aspirin and/or placebo and will: * perform hand grip exercise and cold pressor tests * undergo iontophoresis and blood draw Researchers will compare women with and without endometriosis to see if there is a difference in neurovascular regulation.

Endometriosis and Microvascular Dysfunction: Role of Inflammation

The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction. Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. The investigators hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is systemic inflammation and activation of LOX-1 receptor mechanisms.