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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A non-invasive blood-based test | Experimental | A non-invasive blood-based test to detect endometriosis as compared to diagnostic laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A non-invasive blood-based (HerResolve) | Device | A non-invasive blood-based test can detect endometriosis as compared to diagnostic laparoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elaine Ng | Contact | 35052745 | elaineng@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics & Gynaecology The Chinese University of Hong Kong | Recruiting | Hong Kong | China |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy
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| D000091662 | Genital Diseases |