Microbiome and Immunologic Analysis - Women With Endometriosis

NCT04159740 | Completed

• 1 other identifier: 18-011885
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Microbiome composition in genital tract and gastrointestinal tract

  At time of surgery

Secondary Outcomes (1)

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

  At time of surgery

Study Arms (2)

Endometriosis - Cases

Premenopausal women with suspected endometriosis, planning to undergo laparoscopic surgery.

Other: Tissue and blood collection

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

Interventions

Tissue and blood collection OTHER

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

Controls; Endometriosis - Cases

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Endometriosis

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Marina R Walther-Antonio, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Adela G Cope, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 12, 2019
• Study Start: February 6, 2020
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)