HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A non-invasive blood-based (HerResolve).
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study for HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women of Ages 18-49 Years Considering Laparoscopy
Overview
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.
Interventions
- Device A non-invasive blood-based (HerResolve)
A non-invasive blood-based test can detect endometriosis as compared to diagnostic laparoscopy
Primary outcome measures
- Detecting endometriosis as compared to diagnostic laparoscopy [Time frame: 1 week]
Secondary outcome measures (1)
- Performance Objective: [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Department of Obstetrics & Gynaecology The Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07006987 · 2025.270