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NCT Number: NCT07006987

HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women

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.

Recruiting

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Key information

Conditions

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

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics & Gynaecology The Chinese University of Hong Kong

Hong Kong, China

Location status: Recruiting

Location contact

Jacqueline Pui Wah Chung

CONTACT

[email protected]

+852 3505 1764

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A non-invasive blood-based (HerResolve)

Device

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

Primary outcomes

  1. Detecting endometriosis as compared to diagnostic laparoscopy

    Time frame: 1 week

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

Secondary outcomes

  1. Performance Objective:

    Time frame: 1 year

    Sensitivity: 90% (95% CI: 85%, 98%) Specificity: 90% (95% CI: 85%, 94%) Statistical Analysis will also include PPV and NPV. Sub-group analysis will be performed

Study contacts

Contact information is provided by the study sponsor or research team.

Elaine Ng

CONTACT

[email protected]

35052745

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Clinical Study for HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women of Ages 18-49 Years Considering Laparoscopy

Important dates

Study start
2025
Primary completion
2030
Study completion
2037
First posted
Jun 5, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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