HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women
Recruiting · NCT07006987 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
A non-invasive blood-based (HerResolve)
What this trial is about
Endometriosis (EMS) is a common gynecological disease that affects 176 million girls and women globally. EMS affects 5-10% of women and adolescents within the reproductive age range of 15-49 years, and for those facing infertility, this figure may climb up to 50%. EMS can start at the first menstrual period and last until menopause. Shockingly, between 50% and 80% of women grappling with pelvic pain are found to have EMS. The formation of scar tissue (adhesions, fibrosis) within the pelvis and other parts of the body can cause severe pain and lead to infertility.
Who can take part
Age range
18 Years to 49 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Females aged 18 to 49 with mild to severe symptoms of pelvic pain and/or abnormal bleeding.
- Diagnostic laparoscopy is scheduled with histology on any visually suspected endometriosis, and all reports (surgical and pathology) to confirm a positive result. If no visually suspicious endometriotic lesions are seen, biopsies from random areas during the laparoscopy procedure to confirm a negative histopathology result.
- Blood drawn during secretory or proliferative phase of the menstrual cycle
- Provide written informed consent to participate in the study and provide medical history on medications.
Exclusion criteria
- Patients who object to medical history collection and data requests
- Patients with cancer and/or undergoing chemotherapy and/or radiotherapy
- Patients who are unable or do not undergo laparoscopic surgery
- Patients participating in additional interventional clinical studies
- Pregnant, lactating, or subjects who are not healthy enough for blood donation.
- Blood drawn during menses or ovulation phase of menstrual cycle
- Females who are post-menopausa
Where it is running
1 location listed.
- Department of Obstetrics & Gynaecology The Chinese University of Hong Kong - Hong Kong, China