HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women

NCT07006987 | Recruiting

• 1 other identifier: 2025.270
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Detecting endometriosis as compared to diagnostic laparoscopy

  To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy

  1 week

Secondary Outcomes (1)

• Performance Objective:

  1 year

Study Arms (1)

A non-invasive blood-based test

EXPERIMENTAL

A non-invasive blood-based test to detect endometriosis as compared to diagnostic laparoscopy

Device: A non-invasive blood-based (HerResolve)

Interventions

A non-invasive blood-based (HerResolve) DEVICE

A non-invasive blood-based test can detect endometriosis as compared to diagnostic laparoscopy

A non-invasive blood-based test

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Obstetrics & Gynaecology The Chinese University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Elaine Ng

CONTACT

35052745; elaineng@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): June 1, 2037
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

CN (1)