Ongoing Research Studies re: Endometriosis

research

Figured I’d put together a list of facilities and companies that are presently conducting research studies about Endometriosis.  I’ll update this often (some of these studies may overlap)…  If interested in participating or want more information, click on the name of the study below:

Updated 06/14/17:

Aljazeera Hospital: Egypt.  The aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.

Assistance Publique – Hospitaux de Paris: France. The investigators performed a prospective multicenter comparative study to assess the maternal and fetal risks related to endometriosis during pregnancy, regarding disease phenotype, This study will evaluate with sufficient power the risk of prematurity and obstetrical complications associated with endometriosis according to disease phenotype.  This study aims to provide new informations to pregnant women with endometriosis, guide the monitoring of pregnancy, optimize management strategies based on the nature of complications and ultimately to improve the health of women and their unborn children.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital: Turkey.  The study population will comprise of 90 women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis of serum biomarkers.

Cairo University: Egypt.  Two hundred women aged from 20 to 35 years undergoing conservative laparoscopic treatment of ovarian endometriomas (either by drainage or cyst wall excision) were included. Participants were randomized into 4 groups; group A (drainage only) in which 50 patients underwent laparoscopic fenestration and electrocautery of the endometrioma cyst wall, group B (cystectomy only) in which 50 patients underwent laparoscopic excision of the endometrioma cyst wall, group C (drainage & Surgicel) in which 50 patients underwent laparoscopic fenestration of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel inside the cyst cavity, group D (cystectomy & Surgicel) in which 50 patients underwent laparoscopic excision of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel inside the remaining ovarian tissues.All patients were followed up every 3 months for 2 years following the laparoscopic surgery. The primary outcome was the recurrence of endometriomas in the ipsilateral ovary (recurrence was defined as the presence of ovarian cysts with the characteristic sonographic features of endometriomas (≥1 cm). The ovarian reserve was reassessed (AMH & day 2 AFC) as a secondary outcome 6 months following the laparoscopy.

End to Endo: Via U.S. Mail.  The purpose of this research study is to investigate the genes responsible for predisposing women to endometriosis. By identifying these genetic variants, our team of health professionals and scientists plan to develop noninvasive diagnostics and earlier and more effective therapies for this often-debilitating condition.  We will send you a saliva sample kit.  After completion, you will send these items back to our laboratory in the postage-paid envelope we’ve provided.

Guang’anmen Hospital of China Academy of Chinese Medical Sciences: China. This is a multicenter, double-blind, randomized and placebo-controled trial. the purpose of this trial is to evaluate the efficacy and safety of the Xu-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis syndrome(QS&BSS).QS&BSS is a group of symptoms and signs of human, such as pain in a fixed position, lumps in body, irritability or depression, dim complexion, unsmooth or string-like pulse, purplish tongue or petechia in the tongue. it’s a maladjustment of our body that almost everyone would fall into this condition several times in the long period of our life. it has some potential connections with several kinds of disease, such as cardiovascular,endometriosis, fracture. Xu-Fu-Zhu-Yu capsule is a patent drug which has been approved by the China Food and Drug Administration. It derives from an ancient Chinese traditional medicine formula, which has been used to treat QS&BSS for almost 200 years. Experimental studies have shown that Xu-Fu-Zhu-Yu capsule can treat many kinds of disease, such as coronary heart disease, insomnia, headache. And, all these patients have QS&BSS. So, our research group plan this randomized controlled trial to evaluate the efficacy and safety of the Xu-Fu-Zhu-Yu Capsule in Treatment of QS&BSS. a total of 120 paticipants will be randomly allocated into either the test group or control group in a 1:1 ratio at 3 sites. All paticipants, with different kinds of disease, will be given the standard medical care according to the guidelines. Participants will undergo a 7-week treatment. the primary outcome is the efficacy of QS&BSS and the improvement of single symptom. the secondary outcome is the change in the total score of the patient reported outcomes of QS&BSS(PRO index). Safety outcomes include physical examination (temperature, respiration, heart rate, blood pressure, height and weight), complete blood cell count, urinalysis, stool examination, fecal occult blood test, liver function (alanine aminotransferase(ALT),aspartate transaminase (AST), alkaline phosphatase (ALP), serum total bilirubin (STB), and γ-glutamyl transpeptidase (γ-GT)), renal function (serum creatinine (SCr), blood urea nitrogen (BUN), serum cystatin C, and urine N-acetyl-β-glucosaminidase) and electrocardiogram (ECG) at the first,and seventh weeks.

Highland Clinical Research: Utah.  We are conducting a clinical research study to investigate the effects and effectiveness of a new oral medication indicated for the treatment of endometriosis.

Holbaek Sygehus: Denmark.  The aim of this study is to explore the microRNA profile in serum of women with Polycystic Ovary Syndrome and investigate the correlation between the microRNA profile and markers of metabolic syndrome.

Hospital Universitari de Bellvitge: Spain.  The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol sclerotherapy of endometriomas versus conventional surgery.

Institut Universitari Dexeus: Spain.  To study the recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen.

IVI Sevilla: Spain.  The purpose of this project is to study the presence of expression differences – at RNA and protein level – of different members of the tachykinin family and kisspeptin and their receptors, between fertile women and infertile patients with different etiologies.

Kissei Pharmaceutical Co., Ltd.: Japan.  The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.

Maastricht University Medical Center: Netherlands.  Endometriosis is a common disease for which the current gold standard for diagnosis is a diagnostic laparoscopy with histologic confirmation. However, during the diagnostic laparoscopy endometriotic lesions are hard to identify due to the many appearances of endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence imaging will provide real time image enhancement for the detection of endometriotic lesions by using the different vasculature in the endometriotic lesions. This hypothesis will be tested in a prospective study with 15 patients scheduled for an elective diagnostic laparoscopy for suspected endometriosis.

Nordic Pharma SAS: France.  Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis “expert” centres.  The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.

ObsEva SA: Various locations around globe.  The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

Physicians’ Research Options: Utah, Colorado.  Do you suffer from the agonizing symptoms of endometriosis? A double-blind, placebo controlled study of an investigational GnRh antagonist (non-hormone) medication. A up to 18 month study (up to six months of study participation with a one-year extension study). Participant time and travel compensation up to $2,290.00.

Research OutSmarts Endometriosis (ROSE): New York, but via U.S. Mail.  Researchers involved in ROSE are using several approaches to study endometriosis. These include efforts to better understand the genetic basis of the disease and relate this what is occurring at the cellular level in the disease, with particular emphasis on the role of stem cells and the immune system. Women both living with and living without endometriosis can participate in the ROSE study to help us find answers for those who are suffering.

Royal Surrey County Hospital: United Kingdom. To determine the quality of life following the radical excision of recto-vaginal endometriosis.

SCARM Institute: Iran.  Infertility and miscarriage ordinary events in reproductive failure in humans, as are affected one couple in every six couples of reproductive age and abortion is including in approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains below 30% and Recurrent Implantation Failure in one of the most important limiting factor is the assisted reproductive techniques. According to studies conducted in recent years one of the most important mechanisms of implantation failure is maternal immune system because the fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly associated with implantation failure. It also increases the number of natural killer (NK) cells and Th17 cells and their cytokines in peripheral blood of mother and is also associated with an increased risk of infertility. Several studies have also shown that the fertile persons in compare to infertile have increased amount of Treg cells and inhibitory cytokines associated with it. The studies have shown that if patients are properly selected RIF and placed under appropriate immunotherapy approaches it will be seen a significant increase in fertility. Among the factors affecting the performance of the immune system, small non-coding MicroRNA (miRNA) noted that the RNA of 19-22 nucleotides in length. MicroRNAs act by inhibiting expression of target genes can be linked to pregnancy and implantation process. Hence micro RNAs can be used as biomarkers for the detection, predicting pregnancy and even infertility treatment. Studies have shown that micro-RNAs in the endometrium are in dynamic changes during the menstrual cycle, reproductive system and implantation and diseases such as endometriosis, frequent miscarriage. MicroRNA-1229, miR-133b and miR-223 was proposed to select and review their changes before and after treatment with Rapamycin. Rapamycin is a macrolide fungus was identified about 40 years ago. Biochemical studies on primates led to the identification of molecules mammilian target of rapamycin (mToR) is the target molecule for Rapamycin. MToR molecules play a fundamental role in the regulation of cell metabolism, cell proliferation and mammalian cell response to environmental conditions and play a role in the process of cell growth and cell proliferation. While mTOR Complex 2 (mTORC2) play role in the survival and migration of cells. Rapamycin inhibits T lymphocyte proliferation through inhibit mToRc1 function. In this study, after we selected patients with RIF, according to immunologic disorders are treated with Rapamycin, a drug suppress the immune system is then put the result of treatment with immunological parameters as well as we have evaluated possible effects in success of the implantation and response to treatment.

State Administration of Traditional Chinese Medicine of the People’s Republic of China: China.  his proposed trial is a multicenter,randomized and controlled clinical trial. The aim of this trial is to evaluate the efficacy and safety of acupuncture for treating pain of Endometriosis.The trial period will consist of three menstrual cycles of treatment, and three menstrual cycles in the follow-up period.We put forward the following hypothesis: the effect of acupuncture group is better than the control group on relieving pain.

The First Affiliated Hospital of Zhengzhou University: China.  Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. Since endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the growth of endometriosis by inhibiting ovary function.Some scholars have found that, for adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in patients treated with GnRH-a for 1, or 2 months.

The Women’s Health Study: Massachusetts.  We are trying to understand the factors that affect the health of girls and women. You would be helping us by giving us one piece of this huge jigsaw puzzle.  Volunteers are asked for participation once per year. Up to $35 gift cards from Target or a major online gift card retailer is provided each time you participate.

University Hospital, Montpellier: France. A prospective cohort study would give access to clinical data of patients followed in our center, so as to identify clinical factors predicting pregnancy and to help treatment decision for women with endometriosis suffering from infertility.

University Hospital of Liege: Belgium.  The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients suffering of endometriosis-related chronic pelvic pain (CPP)

University Hospital, Rouen: France.  The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery.

University of Aarhus: Denmark.  To investigate parameters related to fertility in women with endometriosis in relation to food items.

University of Aarhus: Denmark.  This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian and deep infiltrating endometriosis to relevant reference groups. Symptoms are monitored with a questionnaire with the categories quality of life, pain and bowel habits. The EHP-30® questionnaire is included in the questionnaire.

University of Aarhus: Denmark.  This study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. One group will receive mindfulness-based psychological treatment, the second group will receive a non-specific general psychological treatment (a psychological placebo) and the third group will be a waiting list control (treatment as usual).

University of Cagliari: Italy.  The aim of the present study is to validate the italian version of EPH 30, a self reported questionnaire, already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.

University of Messina: Italy.  Accumulating evidence suggests that the peritoneal microenvironment of women affected by endometriosis undergoes a number of local inflammatory-reparative phenomena, with the involvement of resident macrophages, and the attraction and recruitment of peripheral mononuclear cells (monocytes and lymphocytes) from the blood into the peritoneal cavity: during endometriosis a breakdown occurs in endometrial and peritoneal homeostasis caused by cytokine-addressed cell proliferation and dysregulation of apoptosis.  The surrounding microenvironment may address the macrophage plasticity towards a transient and reversible polarization. These polarized phenotypes reflects the proinflammatory or anti-inflammatory status and may change over the time. They could be functionally classified in two main populations: “classically activated” macrophages (M1) and “alternatively activated” macrophages (M2).  Considering that published data so far are still not robust enough to drawn firm conclusion, the aim of this research project will be to evaluate M1 and M2 macrophages in endometriotic tissue from women affected by endometriosis at different stages.

University of North Carolina School of Medicine: North Carolina. The purpose of this study is to determine the effects of progesterone (a naturally occurring hormone) on the endometrium during the time when embryo attachment typically occurs.  This will be compared to women with endometriosis to improve clinical diagnostics and treatments for those suffering from the condition.

University of Zurich: Switzerland.  The current study investigates the quality of life and several risk factors for the development of endometriosis as well as satisfaction with medical support in a minimum of 600 women with different stages of endometriosis and the same number of control women matched for age (± 3 years) and nationality. To evaluate specific features of endometriosis-associated pain a second group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.  A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. Questions on sexuality and partnership are also distributed to women’s partners.

Resources:

Centerwatch

Clinical Trials

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