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Adenomyosis clinical trials

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NCT ID: NCT03940807 Withdrawn - Adenomyosis Clinical Trials

Impact of Ultra-long Versus Long Down-regulation Protocol on IVF/ICSI in Adenomyosis

ADENOFIV
Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

Adenomyosis is a benign condition defined as the invasion of ectopic endometrium into the myometrium, resulting in smooth muscle hyperplasia and endometrial inflammation, commonly associated with endometriosis and uterine fibroids. Heterogeneity among studies regarding diagnostic criteria and therapeutic management has fed the debate surrounding the impact of adenomyosis on assisted reproductive therapy outcomes. Nevertheless, recent data support that adenomyosis impairs reproductive outcomes associated with in vitro fertilization (IVF). According to several experimental data, prolonged exposure to gonadotropin releasing hormone (GnRH) agonists may overcome part of the detrimental impact of adenomyosis on fertility outcome. Overall, GnRH agonist treatment resulted in decreased local production of cytochrome P450 aromatase, decreased intrauterine concentration of free radicals and reduced inflammatory response and angiogenesis in endometrium, myometrium and adenomyosis lesions. At the same time, GnRH agonists affect neither endometrial capacity to support invasion nor invasive potential of the blastocyst in the early stages of implantation. For IVF, 2 main protocols based on GnRH agonist pituitary down-regulation are available: - the long protocol involving a 15 days pituitary down-regulation; - the ultra-long protocol involving a 3 months pituitary down-regulation. Most studies using ultra-long protocol reported similar IVF outcomes in adenomyosis patients and control groups. Conversely, studies involving long or GnRH antagonist protocols demonstrated a significant reduction in clinical and ongoing pregnancy rates in adenomyosis patients compared to control subjects. Thus supporting that ultra-long protocol may be beneficial to improve IVF outcomes in the setting of adenomyosis.This is what investigators would like to demonstrate in this study

NCT ID: NCT03428854 Withdrawn - Adenomyosis Clinical Trials

Adenomyosis: Genomic Mechanisms and Biological Response

Start date: December 1, 2020
Phase:
Study type: Observational

Examination of genomic and biologic responses to LNG-IUS in patients with adenomyosis.

NCT ID: NCT03325868 Withdrawn - Dysmenorrhea Clinical Trials

Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis

Start date: February 2018
Phase: Phase 4
Study type: Interventional

Adenomyosis affects approximately 21% of symptomatic women who present to gynecology clinics. The disease is characterized by heavy bleeding and pain during periods. Limited treatment options exist for the treatment of adenomyosis for women who desire future child-bearing or prefer to avoid surgery. Recently, ulipristal acetate has been studied as a treatment option for women who have fibroids and heavy bleeding. The majority of women treated with ulipristal stopped having periods altogether. Our study aims to determine whether ulipristal is an adequate treatment for women with adenomyosis.

NCT ID: NCT02794467 Withdrawn - Adenomyosis Clinical Trials

Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis

Start date: July 2016
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis. This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.

NCT ID: NCT02160483 Withdrawn - Pelvis Pain Chronic Clinical Trials

Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain

Start date: June 2015
Phase: N/A
Study type: Interventional

Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin labelling, functional connectivity, diffusion tensor imaging and magnetic resonance spectroscopy.