EndometriosisNCT07006987
HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women
A study testing A non-invasive blood-based (HerResolve) in people with Endometriosis, run by Chinese University of Hong Kong at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- A non-invasive blood-based (HerResolve)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2025to 1 Jun 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynaecology The Chinese University of Hong Kong
Hong Kong
Jacqueline Pui Wah Chung, +852 3505 1764, jacquelinechung@cuhk.edu.hk
About this study
Official title: Clinical Study for HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women of Ages 18-49 Years Considering Laparoscopy
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
- Being tested
- A non-invasive blood-based (HerResolve)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A non-invasive blood-based (HerResolve)Device
A non-invasive blood-based test can detect endometriosis as compared to diagnostic laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| A non-invasive blood-based test | Experimental | A non-invasive blood-based test to detect endometriosis as compared to diagnostic laparoscopy Receives: Device: A non-invasive blood-based (HerResolve) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (1)
Performance Objective:
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start14 Oct 2025
- Primary completion31 May 2030 (estimated)
- Study completion1 Jun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006987
- Sponsor's protocol ID
- 2025.270
- Status last verified
- Dec 2025
- First submitted
- 28 May 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women of Ages 18-49 Years Considering Laparoscopy
- ClinicalTrials.gov ID
- NCT07006987
- Acronym / sponsor ID
- 2025.270
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 1 Jun 2037 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy
| Arm | Type | Receives |
|---|---|---|
| A non-invasive blood-based test | Experimental | Device: A non-invasive blood-based (HerResolve)A non-invasive blood-based test to detect endometriosis as compared to diagnostic laparoscopy |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A non-invasive blood-based (HerResolve)A non-invasive blood-based test can detect endometriosis as compared to diagnostic laparoscopy | Device | A non-invasive blood-based test |
Primary outcome
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
1 secondary outcome
Performance Objective:
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A non-invasive blood-based (HerResolve) in people with Endometriosis, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaine Ng (35052745, elaineng@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting endometriosis as compared to diagnostic laparoscopy (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.