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Endometriosis clinical trials

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NCT ID: NCT05558540 Not yet recruiting - Endometriosis Clinical Trials

Spinal Cord Stimulation for Intractable Chronic Lower Abdominal Neuropathic Pain Caused by Endometriosis

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Endometriosis is a chronic, inflammatory disease where endometrium-like tissue is present outside the uterus. Nerve cells in the proximity of this tissue express cytokine receptors causing a signaling cascade. This results in active cross-talk between endometriosis and nerves, causing pelvic pain. Other symptoms associated with endometriosis are cyclical such as dysmenorrhea and dysuria, and non-cyclical such as dyspareunia. Despite adequate disease management, women can still experience endometriosis-related pain. A recent development proven to be efficient in treatment of neuropathic pain, is Spinal Cord Stimulation (SCS). It is also thought to be effective in the treatment of visceral pain. Several studies found Spinal Cord Stimulation (SCS) to be effective in the reduction of endometriosis-related pelvic pain. However, scientific evidence on the efficacy of SCS in visceral pain is limited.

NCT ID: NCT05499884 Not yet recruiting - Endometriosis Clinical Trials

Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis

ECHOENDO
Start date: December 2022
Phase: N/A
Study type: Interventional

The protocol of this study consists in the inclusion of patients with endometriosic rectal involvement with a scheduled intervention. An endovaginal ultrasound will be performed in the operating room by the radiology team to confirm the operative indication of rectal shaving then in a second step a second ultrasound in the operating room will confirm the complete excision of the lesion or the case will allow to perform a more complete gesture (discoid or segmental resection) if the shaving is not sufficient with ultrasound and / or macroscopically

NCT ID: NCT05467852 Not yet recruiting - Pregnancy Rate Clinical Trials

Didroxyprogesterone Promotes Natural Pregnancy in Infertile Patients With Endometriosis

Start date: December 10, 2022
Phase: Phase 3
Study type: Interventional

Endometriosis (EM) is an important cause of infertility in women of childbearing age. Laparoscopic surgery is the treatment of EM Related infertility is an important method. However, excluding other infertility factors, the natural pregnancy rate of EM patients one year after operation is still significantly lower than that of normal couples. At the same time, the high recurrence rate of EM often requires drugs to inhibit ovulation after operation, which forms a paradox with the demand for fertility. One year after operation is the "golden period" of natural pregnancy. Whether to treat the recurrence of EM without affecting or even promoting fertility is a key problem to be solved in clinic. Didroxyprogesterone is the closest natural progesterone. It is widely used in luteal support and treatment of threatened abortion. It does not affect ovulation and is harmless to embryos. In recent years, clinical studies have found that it is helpful to the natural pregnancy of patients with EM after operation, and is beneficial to improve pain symptoms and reduce the recurrence rate. Basic studies have also confirmed the inhibitory effect of didroxyprogesterone on em. However, the existing studies with small sample size are not enough to draw a convincing conclusion that didroxyprogesterone promotes the pregnancy rate after em, and there is a lack of Chinese data. This study intends to use a multicenter, prospective, open, randomized controlled clinical trial design to explore the value of didroxyprogesterone in the treatment of EM related infertility patients, so as to provide direct evidence for improving the postoperative natural pregnancy rate of EM patients.

NCT ID: NCT05298657 Not yet recruiting - Endometriosis Clinical Trials

The Angiotensin-Melatonin Axis in Poor and Hyper Responders for IVF Treatment

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

According the World Health Organization (WHO), infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. In-vitro-fertilization (IVF) is considered to be a successful tool to overcome infertility. However, the current methods used to assess the ovarian reserve and to develop an optimal individualized controlled ovarian hyperstimulation (COH) protocol have shown some limitations. Growing evidence indicates that altered renal renin-angiotensin system (RAS) and/or melatonin are linked to infertility. Aims and Objectives: The current 2 years duration study aims first to investigate the demographic and clinical profiles of patients undergoing IVF in the UAE. In the second phase of the study, we hypothesis that an altered angiotensin-melatonin axis may be considered as an unfavorable prognosis factor in poor and hyper responders undergoing IVF treatment. This hypothesis will be assessed using an observational, longitudinal, prospective clinical study to determine whether the urinary angiotensinogen and/or melatonin deficiency might be present in poor and hyper responders undergoing IVF treatment. Thus, negatively impacting the clinical pregnancy rate. Methodology: various patient's data will be collected using a questionnaire and the levels of angiotensinogen and melatonin in patient's urine will be measured using ELISA test prior to, during and after the IVF treatment. To determine whether the angiotensinogen-melatonin axis disruption affects the IVF treatment outcome, we will analyze the following parameters: the AMH, Antral Follicular Count (AFC), day 2-4 FSH levels, the stimulation cycle in regards to number of stimulation days and amount of gonadotropins used for stimulation, number of oocytes retrieved and number of mature oocytes, quality and embryo's ploidy, number of available euploid embryos and the clinical pregnancy rate after frozen embryo transfer.

NCT ID: NCT04948489 Not yet recruiting - Endometriosis Clinical Trials

IUD and Norethindrone Acetate for Treatment of Endometriosis

Start date: January 1, 2026
Phase: Phase 2
Study type: Interventional

Endometriosis is the most common reproductive disease afflicting young women, often leading to debilitating chronic pelvic pain and impaired quality of life. Safe, effective, and convenient long-term treatments are lacking for adolescents and young adults. The levonorgestrel-containing IUD (LNG-IUD) represents an attractive long-term drug delivery system for the treatment of endometriosis during adolescence and young adulthood. However, while the LNG-IUD has an acceptable safety profile, it is not associated with a favorable bleeding profile and may not fully suppress endometriosis pain when used as monotherapy. Investigators hypothesize that the addition of NETA will improve bleeding patterns, maximize pain control, and improve continuation rates of the IUD when the two medications are used in combination. This proposed prospective trial provides the ideal context in which to investigate these clinical questions and advance research on the best treatments for endometriosis.

NCT ID: NCT04942015 Not yet recruiting - Endometriosis Clinical Trials

Honghuaruyi Wan for Endometriosis Dysmenorrhea

Start date: June 21, 2021
Phase: Phase 4
Study type: Interventional

Endometriosis is a common gynecological disease. It is a gynecological disease caused by the growth and reproduction of the endometrium beyond the surface of the uterine tissue and organs, which causes recurrent abdominal pain, infertility and other main symptoms. The recurrence of endometriosis and the side effects of medication have troubled clinicians and patients for a long time and the search for new drugs is going on all the time. Honghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea. In this study, the therapeutic effects of Honghuaruyi Wan provided by Tibet Qizheng Tibetan Medicine Co.,Ltd on secondary dysmenorrhea in patients with endometriosis was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Honghuaruyi Wan in the treatment of endometriosis dysmenorrhea. In the design of this trial, the therapeutic effects and safety of Honghuaruyi Wan in the treatment of dysmenorrhea secondary to endometriosis were evaluated with Honghuaruyi Wan in the treatment group and placebo in the control group.

NCT ID: NCT04831619 Not yet recruiting - Endometriosis Clinical Trials

Contribution of PET (Positron Emission Tomography) Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

TEP-ENDORUN
Start date: May 2022
Phase: Phase 3
Study type: Interventional

Endometriosis is an inflammatory condition that is often treated by surgery. MRI and ultrasound are used for the preoperative morphological assessment. Currently, only surgery allows the exhaustive and qualitative diagnosis of lesions. The PET scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.

NCT ID: NCT04493476 Not yet recruiting - Endometriosis Clinical Trials

Using a Herbal Remedy Extract for the Treatment of Endometriosis Symptoms

Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

A prospective, double-blind, placebo-controlled trial examining the effect of Chinese herbal medicine combined with curcumin defined as a dietary supplement on a study group of women with endometriosis, compared to control group. research product:Chinese herbal extract and curcumin extract, which appear as nutritional supplements in the Ministry of Health database, the research product is packed in 800mg capsules. Intended use: Composition of 14 different nutritional supplements, in Chinese herbal formula, for the treatment of endometriosis and its symptoms. The formula is formulated according to Chinese medicine principles and aims to reduce inflammation of the pelvic organs and reduce the levels of pain caused by endometriosis disease. Objectives:Examine the Effect of Using Nutritional Supplements on Symptoms in Patients with Targeted Endometriosis Symptoms. Primary Endpoints: Benefit of pain in women suffering from symptoms of endometriosis patients taking herbal extract for 4 months of treatment. Structure of the study:A prospective, double-blind, double-blind, placebo-controlled (randomized) placebo-controlled trial involving women suffering from endometriosis symptoms and meeting the inclusion and exclusion criteria and who agreed to participate in the study. The women will be randomly divided into the following two arms: 1. Study Group - Taking a daily dose of dietary supplement extract capsules 2. Control group - take a daily dose of Invo capsules Treatment efficacy will be measured according to a dedicated patient questionnaire with endometriosis symptoms that assess quality of life measures. The study population will include 60 symptomatic women treated at the Multidisciplinary Center for Endometriosis Therapy at Lynn Medical Center.

NCT ID: NCT04491305 Not yet recruiting - Quality of Life Clinical Trials

EHP-5 in Preoperative Assessment in Women With Endometriosis

EHP-5CRO
Start date: August 1, 2020
Phase:
Study type: Observational

There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. After validation, we will prospectively follow women with endometriosis through whole process - pre- and postoperatively.

NCT ID: NCT04452123 Not yet recruiting - Endometrioma Clinical Trials

Endometrioma Treatment and Ovarian Function

EnTOF
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is recommended when an endometrioma is more than 3 cm in diameter because this management is associated with better spontaneous conception rates. Nevertheless, surgery can also be potentially associated with a risk of destruction of functional ovarian tissue and reduction in ovarian reserve. Anti-müllerian hormone (AMH) is a member of the Transforming Growth Factor beta family and is expressed by the small (<8 mm) pre-antral and early antral follicles. The AMH level reflects the size of the primordial follicle pool, and may be the best biochemical marker of ovarian function across an array of clinical situations Its level in serum is almost stable between 20 and 35 years of the woman´s life, unless using hormonal contraception and / or they suffer with Polycystic ovarian syndrome (PCOS). The level of AMH is also a useful indicator for the prediction chances of success of spontaneous or assisted conceptions. However, there paucity of data regarding changes in serum levels of AMH following surgery for endometrioma. An alternative way for estimating ovarian reserve is quantifying ovarian mass with using standard 3D transvaginal ultrasound calculation (OVM) and assessment of antral follicular count. The gold standard of endometrioma surgery is laparoscopic excision with suture or gentle coagulation of the rest of ovary or by the use of laparoscopic treatment with argon plasma energy.