Ultrasound with saline and fluid testing for superficial endometriosis in adults
Tests saline ultrasound and fluid sampling to check for small surface endometriosis in adults.
Plain-language title generated from the registry record
Registry title: Combining Ultrasound and Biomarkers to Diagnose Superficial Endometriosis
Key facts
- Where
- Hamilton, CanadaSee the site
Where in Canada
- McMaster UniversityHamilton, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- McMaster University
- Trial code
- NCT05523284
- Record updated
- 8 June 2026
- Original description
Endometriosis is a benign gynecological disease characterized by uterine-like cells growing outside the uterus, leading to pain, infertility, and inflammation. Endometriosis most commonly occurs in the forms of Superficial Endometriosis (SE), Deep Endometriosis and Ovarian Endometriosis (Endometrioma) (OE). Ultrasound diagnosis of DE and OE has become more reliable with advances in ultrasound technology, technique and expertise, leading to decreased diagnosis time for patients and allowing for better optimization of surgeries if required. SE, however, lacks any reliable non-invasive diagnosis methods.Read full original descriptionShow less
Transvaginal Ultrasound-guided Culdocentesis for Peritoneal Fluid Cytokines in Patients With Possible Superficial Endometriosis But no Ultrasound-diagnosed Ovarian or Deep Endometriosis (SPG)
Endometriosis is a benign gynecological disease characterized by uterine-like cells growing outside the uterus, leading to pain, infertility, and inflammation. Endometriosis most commonly occurs in the forms of Superficial Endometriosis (SE), Deep Endometriosis and Ovarian Endometriosis (Endometrioma) (OE). Ultrasound diagnosis of DE and OE has become more reliable with advances in ultrasound technology, technique and expertise, leading to decreased diagnosis time for patients and allowing for better optimization of surgeries if required. SE, however, lacks any reliable non-invasive diagnosis methods.
SE is the most common form of endometriosis and is defined as a disease that lines the peritoneum and is small and superficial in nature, leading to chronic inflammation, infertility, and pain. SE is difficult to visualize on ultrasound due to its size and alignment with tissue, requiring fluid to expand the pelvis and partially suspend these small lesions, allowing them to be diagnosed through ultrasound. Leonardi et al. observed that in some patients, a physiologic change occurs whereby fluid fills the pouch of Douglas (POD), allowing increased visualizing during ultrasound. This led to the development of Saline-infused sonoPODgraphy (SPG), a novel method utilizing modified commonly used ultrasound techniques called saline-infusion sonohysterography (SIS) and hysterosalpingo-contrast-sonography (HyCoSy), to reliably visualize the POD (Leonardi et al, 2019). Visualizing the POD is important as SE is often deposited in the POD.
This diagnostic accuracy pilot study aims to pioneer the technique whereby SPG will be evaluated as a novel, rapid, non-invasive diagnostic tool for SE. The injected fluid from the POD will be withdrawn and evaluated for novel biomarkers, allowing us to further develop rapid diagnostics and better understand disease mechanisms. We hypothesize that SPG will allow for the diagnosis of SE with a diagnostic accuracy parallel to the current invasive gold standard, laparoscopy.
Inclusion: 18 Years of Age; Assigned Female at Birth; Confirmed or Suspected Case of Superficial Endometriosis; Willing and Able to Provide Informed Written Consent.
Exclusion: No History of Vaginal Penetration / Intercourse; Concern for pre-malignancy or presence/history of malignancy; Known Bleeding Disorder; Pre-Menarche or Post-Menopausal; Presence of Deep or Ovarian Endometriosis.