About this trial
Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Despite intensive research in the field of etiopathogenesis, its cause has not yet been determined, and treatment remains symptomatic. Endometriosis causes two main complications, i.e. pelvic pain syndrome and infertility. In recent years, thanks to the analysis of the human microbiome, it has become possible to deepen the knowledge of the physiological and pathological interactions between microorganisms inhabiting various body areas and the host. Bacteria may enter the peritoneal cavity in the mechanism of retrograde menstruation and translocate from the intestines, and then promote the development of local and systemic inflammation, leading to the symptoms of endometriosis. The study is to determine whether the presence of a specific intestinal, peritoneal and uterine microbiome correlates with endometriosis stage and whether its presence predisposes to increased pain or infertility. Concordance or divergence of bacterial populations inhabiting the peritoneal and uterine cavities could have clinical implications, i.e. the possibility of empirical antibiotic therapy in patients undergoing only endometrial aspiration biopsy and not opting for surgical treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18-45 years
indications for surgical treatment of endometriosis by laparoscopy and/or indications for invasive diagnostics by laparoscopy due to idiopathic infertility.
Disqualifiers
abdominal surgeries performed within 6 months prior hospitalisation
active infection of the genital tract
inflammatory bowel disease
antibiotic therapy and use of probiotics within 3 months before surgery
Trial design
Parallel
Treatments tested in this trial
Next Generation Sequencing (NGS)
Diagnostic testBiological materials (stool, peritoneal/ovarian cyst fluid, endometrial aspirate) will be secured and then subjected to molecular analysis using the Next Generation Sequencing (NGS) method. The stages will include: i) isolation of bacterial DNA from biological materials, ii) preparation of libraries for sequencing, including the performance of the PCR and nested-PCR methods on bacterial DNA isolates from the tested samples of biological materials, iii) purification of amplification products, indexing, validation of the concentration of amplicons, pooling and denaturation of libraries, iv) standardization and optimization of the procedure for the isolation of bacterial metagenomic DNA from biological materials from intestines, peritoneal cavity, uterine cavity and endometrial tissues, v) standardization of the nested-PCR method on bacterial DNA isolates from the tested biological materials, vi) submission of samples for sequencing.
Treatment groups
Trial outcomes
Primary outcomes
Composition of intestinal, peritoneal and uterine microbiome in both study arms
Percentage composition of the local bacterial population by phyla and genera
Secondary outcomes
Relation of the composition of intestinal, peritoneal and uterine microbiome and endometriosis stage
Correlation between the percentage composition of the local bacterial population (by phyla and genera) and the ASRM endometriosis stage
Relation of the uterine microbiome to the intestinal and peritoneal microbiome in women with endometriosis and idiopathic infertility
Correlation between the percentage composition of the uterine bacterial population (by phyla and genera) and the percentage composition of the intestinal and peritoneal microbiome (by phyla and genera)
Relation of intestinal, peritoneal and uterine microbiome and symptoms
Correlation between the percentage composition of local microbiomes (by phyla and genera) and the severity of pain symptoms on the Numeric Rating Scale (NRS from 0 - no pain to 10 - maximum pain) and the duration of infertility (in years)
Composition of intestinal, peritoneal and uterineand quality of life
Correlation between the percentage composition of local microbiomes (by phyla and genera) and the percentage result of the SF-36 questionnaire evaluating of 8 area of life on a scale from 0% - the worst quality to 100% - the best quality
Sponsors and contacts
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