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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometriosis - Cases | Premenopausal women with suspected endometriosis, planning to undergo laparoscopic surgery. |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue and blood collection | Other | Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome composition in genital tract and gastrointestinal tract | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Immunostaining of eutopic and ectopic endometrium for immune factors, immune cells, and fibrosis | At time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Premenopausal women with or without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications.
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| Name | Affiliation | Role |
|---|---|---|
| Marina R Walther-Antonio, Ph.D. | Mayo Clinic | Principal Investigator |
| Adela G Cope, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D000091662 | Genital Diseases |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |