HerResolveTM Clinical Performance Study

Overview

About this study

The purpose of this study is to demonstrate the performance of the HerResolveTM blood-based test in detecting endometriosis as compared to diagnostic laparoscopy among mild-severe symptomatic women of ages 18-49 years.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Females age 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) are available to confirm a positive result. If no visually suspicious endometriotic lesions are seen, biopsies from random areas during 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 collection.

  • Blood drawn during menses or ovulation phase of menstrual cycle.

  • Females who are post-menopausal.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/13/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Megan Wasson

Contact us for the latest status

Contact information:

Xavier Lopez

(480) 342-2906

lopez.xavier@mayo.edu

More information

Publications

Publications are currently not available