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OpenTrials
Completed

NCT Number: NCT03002870

Characteristics of Patient Population With Endometriosis

The purpose of this study is to collect and analyze data on the characteristics of women who are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as part of their standard medical care. Data collected will contribute to the development of guidelines for the surgical management of endometriosis. In addition, specimens will be collected for future testing regarding diagnosing, and/or staging of endometriosis, or suspected endometriosis, pain and infertility.

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Key information

Age range

13 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University

St Louis, Missouri, 63117, United States

About this study

Patients seen at Saint Louis University Center for Endometriosis (which has offices locations at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system), and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St. Mary's hospital (only).

A preoperative questionnaire will be provided to the subject. Questions from the survey include information on baseline demographics, severity and type of pain, and previous medical and surgical history. Operative data will also be collected and analyzed.

A post-operative questionnaire will be administered to the participants at 6 months, and then at regular yearly intervals after the surgery by a secure on-line process using the RedCap software. Improvement in quality of life and pain scores will be analyzed.

Specimens will also be collected and stored for future testing regarding diagnosing, and/or staging of endometriosis, suspected endometriosis, pain and infertility.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients
  • 13-55 years of age
  • Anyone seen at the Center for Endometriosis

Exclusion criteria

  • Prior bilateral salpingo-oophorectomy
  • post natural menopause
  • Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.

Treatment and study plan

questionnaires

Other

Patients will receive questionnaires yearly to follow their QOL

Primary outcomes

  1. Quality of life, pain and fertility

    Time frame: every 12 months

    (QOL) endometriosis health profile (EHP-5)

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

Characteristics of Patient Population With Endometriosis - A Prospective Database and BioBank

Acronym: 20900

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2016
Registry last updated
Sep 19, 2024

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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