Endometriosis and Chronic Endometritis
Condition: Endometriosis; Pelvic Pain; Infertility
MeSH terms: Infertility; Endometriosis; Endometritis; Pelvic Pain
Study type: Interventional

Summary: 
      Pelvic endometriosis is a complex estrogen-dependent inflammatory syndrome of unknown
      etiology, altering the microenvironment of the peritoneal cavity and probably endometrial
      receptivity, and adversely affecting the physiological processes associated with
      fertilization. Literature data suggest that the distribution of immune system cells in the
      eutopic endometrium in the presence of endometriosis differs from the physiological state.
      The functioning of the immune system seems to be significantly modified not only in the foci
      of endometriosis, but also in the eutopic endometrium, affecting its physiological functions.
      Chronic endometritis (CE) is a potential factor impairing endometrial receptivity in the
      course of endometriosis. However, it is not known whether CE is one of the complications of
      endometriosis or perhaps an element of its pathogenesis. At the moment, endometrial
      diagnostics is not obligatory in the treatment of endometriosis in women of reproductive age,
      but it could potentially bring additional benefits and contribute to the improvement of
      obstetric results and increase the effectiveness of infertility treatment in women with
      endometriosis.
    

Detailed description: 
      The aim of the study is:

      i) Evaluation of the incidence and activity of CE (expressed as the number of plasma cells /
      1 High Power Field, HPF) in women undergoing surgical treatment for pelvic endometriosis due
      to pain or infertility; ii) Evaluation of the correlation of CE activity (expressed as the
      number of plasma cells/ 1 HPF) with endometriosis staging according to the American Society
      for Reproductive Medicine Classification System iii) Evaluation of the impact of surgical
      removal of pelvic endometriosis foci on CE activity iv) Comparison of the percentage of women
      with persistent CE after surgery in the subgroup receiving empiric antibiotics (Amoxicillin +
      Clavulanic Acid 875 mg + 125 mg, twice daily orally for 7 days) and the subgroup without
      antibiotics. The study will include women aged 18-45 undergoing laparoscopic surgery for
      pelvic endometriosis. Additionally, an endometrial aspiration biopsy will be performed.
      Endometriosis will be confirmed by histopathology. The stage of endometriosis will be
      determined according to revised American Society for Reproductive Medicine Classification. CE
      will be confirmed by histopathology and immunohistochemical staining with monoclonal murine
      antibodies against human plasma cells CD138, and will be defined as the presence of plasma
      cells in the endometrial stroma, the value will be given as the number of plasma cells/1 High
      Power Field (HPF) and the cut-off will be calculated using the receiver operating
      characteristic (ROC) curve. A control endometrial biopsy to confirm the effectiveness of
      empiric antibiotic therapy will be performed up to 3 cycles after the primary procedure.
    

Intervention name(s): Endometrial aspiration biopsies for CE diagnosis
Intervention type(s): Diagnostic Test
Intervention description(s): 1 ml of aspirate will be taken from the uterine cavity for histopathological examination and immunohistochemistry for CE during general anesthesia for scheduled surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective cohort tertiary single-center study
Masking: None (Open Label)
Primary purpose: Diagnostic