A Study to Analyze the Microbiome and Immunology of the Lower and Upper Female Reproductive Tract in Women with Endometriosis

Overview

About this study

The purpose of this study is to map the female reproductive tract microbiome in patients with and without endometriosis to seek correlations of the microbiome to endometriosis, to determine if lower reproductive tract microbiome is predictive of upper reproductive tract changes by comparing composition of the microbiome in the lower and upper reproductive tracts, to explore immunologic differences in patients with and without endometriosis, compare presence of immunologic factors and cells between ectopic and eutopic endometrium, and to compare systemic immune system characteristics in patients with and without endometriosis using mass cytometry of peripheral blood samples.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Females, ≥ age 18 years old.
  • Females undergoing laparoscopy with or without hysterectomy for benign indications: suspected endometriosis for cases; elective salpingectomy/tubal ligation without endometriosis for controls.If insufficient numbers of subjects undergoing sterilization are available for recruitment, we will also include subjects undergoing surgery for abnormal uterine bleeding as controls.
  • Have not been on hormone therapy for endometriosis or contraception in the past 4 weeks before surgery.

Exclusion Criteria:

  • Women who are pregnant or nursing.
  • Women who are postmenopausal.
  • Women who are status post hysterectomy or bilateral oophorectomy.
  • Currently taking or have taken antibiotics in the past 4 weeks.
  • Current diagnosis of vaginitis or treatment for vaginitis in the past 6 months.
  • Females undergoing hysterectomy by abdominal or vaginal approaches.
  • Females undergoing hysterectomy or laparoscopic procedure for suspected malignancy.
  • Currently on hormone therapy for endometriosis or contraception.
  • History of autoimmune or inflammatory disease.*
  • *Exceptions may be permitted at the discretion of the investigator

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marina Walther-Antonio, Ph.D.

Open for enrollment

Contact information:

Maureen Lemens R.N., C.C.R.C.

(507)293-1487

Lemens.Maureen@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20458950

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