Microbiome and Immunologic Analysis - Women With Endometriosis

Microbiome and Immunologic Analysis of the Lower and Upper Female Reproductive Tract in 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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Other: Tissue and blood collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women with or without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endometriosis - Cases; Premenopausal women with suspected endometriosis, planning to undergo laparoscopic surgery.	Other: Tissue and blood collection; Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.
Controls; Premenopausal women without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications including elective salpingectomy, tubal ligation or surgical procedures for abnormal uterine bleeding	Other: Tissue and blood collection; Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Microbiome composition in genital tract and gastrointestinal tract	At time of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunostaining of eutopic and ectopic endometrium for immune factors, immune cells, and fibrosis	At time of surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Marina R Walther-Antonio, Ph.D., Mayo Clinic; Study Chair: Adela G Cope, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 18-011885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No