Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946655
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-06-29
Brief Title:
Diagnostics of Chronic Endometritis in Infertility
Sponsor:
Jagiellonian University
Organization:
Jagiellonian University
Study Overview
Official Title:
Evaluation of the Congruity of Methods Used in the Diagnostics of Chronic Endometritis in the Course of Infertility and the Effectiveness of Antibiotic Therapy in the Context of Remission of Symptoms and Obstetric Results
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic endometritis CE is characterized by the presence of atypical plasma cell infiltrates CD138 positive in the endometrial stroma Recent analyzes suggest that CE adversely affects fertility by reducing endometrial receptivity impairing decidualization and uterine contractility thus increasing the risk of recurrent pregnancy loss and implantation failure It is likely that a significant proportion of idiopathic infertility cases are due to CE The diagnosis of CE is a challenge because the clinical examination and transvaginal ultrasonography are considered non-specific The recent scientific research has been aimed at identifying hysteroscopic CE diagnostic criteria and establishing the compatibility of ultrasonographic hysteroscopic histopathological including the use of immunohistochemical testing with antibodies against human CD138 and microbiological diagnoses Preliminary literature results suggested that successful treatment of CE with antibiotics could improve live birth rates
Detailed Description:
The main objective of the study is to estimate the incidence of chronic endometritis CE in the population of women of childbearing age who underwent hysteroscopy for infertility The specific objectives are as follows
1 Estimation of the diagnostic congruity of hysteroscopic histopathological and microbiological diagnoses of CE
2 Estimation of the effectiveness of empirical antibiotic therapy in the treatment of CE confirmed by normalization of the hysteroscopic appearance of the uterine cavity normalization of histopathological results of endometrial biopsies and decrease in plasma cell count1 mm2
3 Estimation of the percentage of clinical pregnancies achieved in women subjected to empiric antibiotic therapy for CE vs in women without treatment The study group will consist of women of childbearing age subjected hysteroscopy due to idiopathic infertility The prerequisite for hysteroscopy is a normal cervical cytology result a negative blood pregnancy test a normal vaginal biocenosis and the first phase of the cycle During hysteroscopy the following will be performed visual inspection of the uterine cavity in search of focal lesions and features of the endometrium suggestive of CE such as focal or diffuse hyperemia micropolyps stromal edema then collection of washings from the uterine cavity for microbiological examination aerobic and anaerobic culture PCR for Chlamydia culture for Mycoplasma Ureaplsma and excision of the focal lesion or endometrial biopsy The extracted tissue material will be subjected to standard histopathological examination with hematoxylin and eosin staining Additional immunohistochemical staining with Monoclonal Mouse Anti-Human CD138 antibodies will be used to detect plasmocytes The cut-off point for the number of CE-defining plasmocytes will be determined by the Receiver Operating Characteristic ROC curve Women with infertility diagnosed with CE will be randomized to 2 arms 1 ofloxacin 2x200 mg orally for 10 days metronidazole 1x500 mg vaginally for 10 days 2 control arm no treatment After 3 cycles from surgery or completion of treatment women will undergo a repeat hysteroscopy for a visual assessment of the uterine cavity and a follow-up endometrial biopsy The percentage of women with improvement in the clinical appearance of the uterine cavity normalization of histopathology and persistent CE in both arms will be determined Data will be obtained on the results of infertility treatment obtaining a clinical pregnancy within 12 months of the procedure or completion of antibiotic therapy
1 Estimation of the diagnostic congruity of hysteroscopic histopathological and microbiological diagnoses of CE
2 Estimation of the effectiveness of empirical antibiotic therapy in the treatment of CE confirmed by normalization of the hysteroscopic appearance of the uterine cavity normalization of histopathological results of endometrial biopsies and decrease in plasma cell count1 mm2
3 Estimation of the percentage of clinical pregnancies achieved in women subjected to empiric antibiotic therapy for CE vs in women without treatment The study group will consist of women of childbearing age subjected hysteroscopy due to idiopathic infertility The prerequisite for hysteroscopy is a normal cervical cytology result a negative blood pregnancy test a normal vaginal biocenosis and the first phase of the cycle During hysteroscopy the following will be performed visual inspection of the uterine cavity in search of focal lesions and features of the endometrium suggestive of CE such as focal or diffuse hyperemia micropolyps stromal edema then collection of washings from the uterine cavity for microbiological examination aerobic and anaerobic culture PCR for Chlamydia culture for Mycoplasma Ureaplsma and excision of the focal lesion or endometrial biopsy The extracted tissue material will be subjected to standard histopathological examination with hematoxylin and eosin staining Additional immunohistochemical staining with Monoclonal Mouse Anti-Human CD138 antibodies will be used to detect plasmocytes The cut-off point for the number of CE-defining plasmocytes will be determined by the Receiver Operating Characteristic ROC curve Women with infertility diagnosed with CE will be randomized to 2 arms 1 ofloxacin 2x200 mg orally for 10 days metronidazole 1x500 mg vaginally for 10 days 2 control arm no treatment After 3 cycles from surgery or completion of treatment women will undergo a repeat hysteroscopy for a visual assessment of the uterine cavity and a follow-up endometrial biopsy The percentage of women with improvement in the clinical appearance of the uterine cavity normalization of histopathology and persistent CE in both arms will be determined Data will be obtained on the results of infertility treatment obtaining a clinical pregnancy within 12 months of the procedure or completion of antibiotic therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None