View clinical trials related to Endometriosis.
Filter by:Endometriosis is a chronic inflammatory disease that affects approximately 10-15% of women of reproductive age. Symptoms include dysmenorrhoea, chronic pelvic pain, dyspareunia and infertility. Removal of the endometriotic cyst (chocolate cyst) by surgery is a well-established treatment for symptomatic relief. However, recurrence of endometriotic cyst after surgical removal of the cyst is up to 30-50% after ovarian surgery. Oral contraceptive pills for 18-24 months after the surgery is widely used as a postoperative hormonal therapy because it has been shown to reduce the chance of recurrence of the endometriotic cyst, but recurrence is still high even after taking oral contraceptive pills. Letrozole is an aromatase inhibitor. There are some preliminary reports that letrozole can cause shrinkage of endometriotic cysts and improve endometriosis-related pelvic pain by reducing oestrogen level, inflammation and stem cell recruitment that may be important in recurrence of endometriotic cyst. This is a randomized double-blinded placebo-controlled trial. The aim of this study is to assess whether taking letrozole in addition to oral contraceptive pills in the first 6 months after laparoscopic surgery (key-hole surgery) to remove the endometriotic cyst can reduce the risk of recurrence compared to oral contraceptive pills alone. The study also involves laboratory parts from a small portion of the endometriotic cyst specimens (removed during laparoscopy ovarian cystectomy) and endometrial biopsy (if the patient agrees) to assess the role of stem cells in the pathogenesis of endometriotic cysts.
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.
Oxidative stress has been investigated as a key factor in the pathogenesis and progression of endometrioma. High follicular fluid ROS levels and serum can be related to negative IVF/ICSI outcomes in infertile women with endometrioma. Therefore, the use of antioxidants such as N-acetyl cysteine (NAC) may be reduced complications of endometrioma. To study this hypothesis, we designed a double-blind, randomized clinical trial study that aimed to determine the effect of N-acetyl cysteine (NAC) on stress oxidative factors and pregnancy outcomes in IVF/ICSI cycles in endometrioma patients.
Endometriosis is an estrogen-dependent chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterine cavity. This pathology has a prevalence of about 5-10% in reproductive-aged women. Endometriosis therapy uses two options: surgical or medical (hormonal) but none can be considered completely resolving. Related signs and symptoms include dysmenorrhea, dyspareunia, infertility, dysuria and dyschezia. In addition to typical gynecological symptoms, gastrointestinal symptoms (bloating, nausea, constipation, diarrhea and vomiting) affect up to 90% of patients with endometriosis. Despite its high prevalence and associated morbidity, its etiology is still unclear and is thought to be multifactorial, and genetic, hormonal, environmental and immunological factors contribute to it. Several studies have shown a significant association between abnormal immune response and maintenance of disease activity in women with endometriosis. The microbiome contains all the genetic material of microbes, including bacteria, fungi, viruses and Archaea, which live inside the host and regulate various physiological functions. The set of these bacteria, fungi, viruses and Archaea is called a microbiota. The influence of the microbiome on immunomodulation and the development of various inflammatory diseases is well established. Conversely, little is known about the presence and composition of the microbiome in the female reproductive system and its role in the development of endometriosis or other gynecological conditions. Considering the altered inflammatory state typical of endometriosis, it seems logical to postulate a potential role of the microbiome in the etiopathogenesis of this pathology. Interestingly, the microbiome affects estrogen metabolism and estrogen affects the gut microbiome. Since endometriosis is an estrogen-dependent disease, a picture of intestinal dysbiosis resulting in abnormal circulating estrogen levels could potentially contribute to the development of this disease.
The study aims to investigate the nutritional status and eating habits of women suffering from endometriosis and chronic pelvic pain in relation to describe the possible improvement of clinical symptoms following a nutritional intervention. The primary aim is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain. The first secondary aim will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some specific areas of the patients (sexual, psychological) together with the quantification of some routine blood chemistry parameters (inflammatory markers, levels of proteins and vitamins) . The second secondary objective will be aimed at describing the changes in clinical symptoms and the parameters mentioned above in patients based on the severity/stage of the pathologies under study.
A pilot study to investigate the potential role of atosiban, a selective oxytocin receptor inhibitor, in the management of endometriosis-related pain. Ten patients will be administered atosiban intravenously during 6 hours on a day during their period when they experience (severe) pain
Endometriosis is the presence of endometrial glands and stroma outside the uterine cavity. About 5% of women of reproductive age suffer from the disease. The pelvis is the most frequent site of endometriotic lesion and the most common pelvic localisations are peritoneal, ovarian, and deep infiltrating endometriosis. However, endometriosis can also localize outside the pelvis, for example involving the umbilicus, omentum, appendix, liver, diaphragm, pleura and lungs, vulva, and surgical scars. The majority of extrapelvic endometriosis implants are located in the skin, and most of them are of iatrogenic origin, following laparotomy, laparoscopic procedures, and episiotomies; only a minority of cases are of primary origin. Umbilical endometriosis is a very rare presentation of endometriosis (0.5-1% of cases of extrapelvic endometriosis). Pathogenetic hypotheses of primary umbilical endometriosis include: hematic or lymphatic dissemination of endometrial cells from the peritoneum to the umbilicus through obliterated umbilical arteries; migration of endometrial cells through the venous or lymphatic circulation; metaplasia of urachus remnant or release of endometrial cells that during labor and delivery may contaminate the umbilical cord emergence. Secondary umbilical endometriosis is probably due to the proliferation and subsequent dissemination of iatrogenically implanted endometrial cells in laparotomy or laparoscopic scars. In 20% of cases, umbilical endometriosis is associated with pelvic endometriosis. In these patients, it is probable that endometriotic cells may migrate from the endometriotic implants to the umbilical site. This migration process could be favored by fascia defects at the umbilical level. In fact, reports in the literature describe cases of umbilical endometriosis coexisting with umbilical hernia. The clinical presentation consists of an umbilical nodule of variable color (red, blue, black, flesh-colored), ranging in size from 0.5 to 3 cm. Pathognomonic symptoms are: bleeding and/or pain in the umbilical site of catamenial type, cutaneous hyperesthesia. Catamenial symptomatology associated with the nodule, which makes the diagnosis easier, is present in only 75% of cases. In asymptomatic cases the differential diagnosis of the nodule of umbilical endometriosis is more difficult (hernia, hematoma, cyst, dermatological disorders, tumor metastasis). Instrumental examinations useful for differential diagnosis and definition of nodule size include soft tissue ultrasound, CT scan and MRI. Definitive diagnosis is only by histologic examination of the tissue. Exploratory laparoscopy is not indicated unless concomitant pelvic endometriosis is suspected. The recommended treatment of umbilical endometriosis is surgical, consisting of complete removal of the endometriosis nodule, omphalectomy, and subsequent reconstruction of the umbilicus. Recurrence rates after surgery are around 6% at 12 months in a large Japanese court, with no difference between taking and not taking postoperative hormonal therapy, while they are reduced to almost 0% in case of resection including a large portion of peritoneum. Medical therapy, on the other hand, alleviates the associated algic symptoms by reducing the size of the nodule. There are very few data on the efficacy of medical therapy; in a study with a very small number of cases an efficacy of 91.7% with dienogest and 51.1% with estroprogestinic pill is reported. There are no studies comparing medical and surgical therapy for the treatment of umbilical endometriosis. Radical excision is recommended to avoid local recurrences and to avoid the risk of malignant transformation, although it is extremely rare (only 2 cases reported). In literature, spontaneous resolution has been described in only one pregnant woman. To date, few studies have evaluated umbilical endometriosis. Moreover, no study has ever formally compared the long-term efficacy of surgical or medical therapy for umbilical endometriosis. This is a observational, retrospective/prospective and monocentric study; it is based on the review of medical records and on outpatient follow-up visits of patients in our clinic with umbilical endometriosis from 1990. The principal aim of the study is to evaluate the effectiveness of medical and surgical treatments in terms of satisfaction, psychological state, health-related quality of life of patients suffering from this clinical condition. Moreover, global patient's condition and severity of the patient's symptoms are evaluated The secondary aim is to investigate the pathogenetic aspects of this clinical condition.
Background: Endometriosis is a common disease, affecting women in their reproductive age suffering from infertility, adnexal masses and chronic pelvic pain, obstruction of the bowel or urinary tract. Deeply infiltrating endometriosis (DIE) is defined as a solid endometriosis mass situated more than 5 mm deep to the peritoneum. These lesions are considered very active and are strongly associated with pelvic pain symptoms. Surgery is recommended in women with pain resistant to medical therapy and in women with contraindications to or refusal of medical therapy. Further indications for surgical treatment are the need of excluding malignancy in an adnexal mass, obstruction of the bowel or urinary tract. It is hypothesized that in patients with lesions in complex anatomic sites, a robot-assisted approach may provide improved instrument articulation compared with conventional laparoscopy, but no data are available. Aims: The aim of this study is to perform a pilot study investigating differences between robot-assisted laparoscopy compared to conventional laparoscopy regarding subjective symptom outcome, evaluated by VAS score for non-menstrual pelvic pain and dysmenorrhea. Study population: The study population will consist of women aged between 18 and 51 years who are referred to our gynecologic outpatient clinic due to symptomatic endometriosis. Women with suggested DIE and an indication for surgery can be included in this trial. Methods: Laparoscopic-assisted resection of endometriosis will be performed using up to five 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. Superficial and deep endometriosis resection will be performed in the usual standard fashion. Histological confirmation of endometriosis will be performed. The primary outcome is subjective symptom improvement. This will be evaluated by visual analog scale (VAS) for dysmenorrhea and non-menstrual pelvic pain on a daily basis for at least 1 calendar month before the operation to obtain adequate baseline measurements. This evaluation will be repeated 3 and 6 months after surgery.
We aimed to investigate whether endometrial scratching could improve IVF outcomes by enhancing endometrial receptivity in patients with endometriosis.
The aim of this study is to perform a randomized study investigating AMH recovery comparing robot-assisted laparoscopy and conventional laparoscopy in patients with bilateral ovarian endometrioma. It is hypothesized that in patients with endometriomas, a robot-assisted approach may provide improved instrument navigation resulting in more precise dissection and therefore removal of less healthy ovarian tissue compared to conventional laparoscopy. AMH is the most widely used parameter for predicting functional ovarian reserve. Postoperative AMH levels were associated with the number of follicles in specimens due to the removal of ovarian cortex during surgery . Furthermore, the reduction in AMH level after surgery is higher in bilateral endometrioma. The investigators hypothesize, on the basis of Lee at al., 2020, that patients with bilateral endometrioma will have significantly higher AMH levels 6 months after robot-assisted laparoscopy than patients who were treated with conventional laparoscopy. Therefore, the primary outcome is postoperative serum AMH level recovery in patients undergoing conventional laparoscopy versus robot-assisted laparoscopy. Aims: The aim of this study is to investigate postoperative differences in ovarian reserve differing between robot-assisted laparoscopy compared to conventional laparoscopy in patients with bilaterial ovarian endometrioma by comparing serum AMH (sAMH) level recovery. Study population: The study population will consist of women aged between 18 and 45 years who are referred to our gynecologic outpatient clinic due to bilateral endometrioma. Women with an indication for surgery can be included in this trial. Methods: Laparoscopic-assisted resection of endometriosis will be performed using up to four 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. Superficial and deep endometriosis resection will be performed in the usual standard fashion. Histological confirmation of endometriosis will be performed. The primary outcome is postoperative serum AMH (sAMH) level recovery. This will be evaluated 6 months after surgery.