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OpenTrials
Completed

NCT Number: NCT04159740

Microbiome and Immunologic Analysis - Women With Endometriosis

The primary goal of this study is to assess differences in the microbiome between women with and without endometriosis.

A second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis.

In order to investigate these areas of interest, 25 women with endometriosis and 25 women without endometriosis will be enrolled. All women will be undergoing a previously scheduled surgical procedure at which time presence or absence of endometriosis will be confirmed and specimens will be obtained.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Endometriosis is a chronic gynecologic condition where implants of endometrial glands and stroma are present outside of the uterus. It occurs in 6-10% of women of reproductive age and is characterized by dysmenorrhea, chronic pelvic pain, dyspareunia, or infertility. In addition to symptom burden, there are significant direct costs related to diagnosis and treatment of disease, as well as indirect costs related to absenteeism from school and work, loss of productivity, and unemployment. The estimated national economic burden in the United States related to these costs is approximately 78 billion dollars per year. While clinical signs and symptoms may be suggestive of endometriosis, the gold standard for diagnosis requires surgical confirmation of disease.

The pathogenesis of endometriosis is complex and likely multifactorial with genetic, epigenetic, environmental, and immunologic factors. An increasing number of studies have also suggested the role of the microbiome in human health and development of disease. This study aims to investigate possible differences in the microbiome and immunologic factors that could contribute to pathogenesis of this disease. Findings from this study could potentially contribute to the development of of a less invasive, non-surgical diagnostic test for endometriosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females, age 18 years or older
  • Undergoing laparoscopy (conventional or robotic) with or without hysterectomy for non-cancer indications and including women from two groups:
  • Suspected endometriosis
  • Elective salpingectomy or tubal ligation or abnormal uterine bleeding
  • Understands study procedures
  • Willing and able to provide signed informed consent

Exclusion criteria

  • Postmenopausal
  • Currently pregnant or lactating
  • Prior hysterectomy or oophorectomy
  • Undergoing hysterectomy via vaginal or abdominal approach
  • Undergoing hysterectomy or laparoscopy for suspected malignancy
  • Use of antibiotics within 2 weeks prior to surgery
  • Use of hormone therapy for endometriosis or contraception within 4 weeks prior to surgery
  • Diagnosis or treatment of vaginitis during the past 6 months prior to surgery
  • Personal history of autoimmune or inflammatory disease

Treatment and study plan

Tissue and blood collection

Other

Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.

Primary outcomes

  1. Microbiome composition in genital tract and gastrointestinal tract

    Time frame: At time of surgery

Secondary outcomes

  1. Immunostaining of eutopic and ectopic endometrium for immune factors, immune cells, and fibrosis

    Time frame: At time of surgery

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Microbiome and Immunologic Analysis of the Lower and Upper Female Reproductive Tract in Women With Endometriosis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 12, 2019
Registry last updated
Mar 1, 2023

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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