Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions
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|ClinicalTrials.gov Identifier: NCT02744807|
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment|
|Intrauterine Adhesions Chronic Endometritis||Other: Chronic endometritis|
|Study Type :||Observational|
|Actual Enrollment :||125 participants|
|Official Title:||Prevalence of Chronic Endometritis in Severe Intrauterine Adhesions and Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||February 2016|
patients with intrauterine adhesion only
patients with intrauterine adhesion as well as Chronic endometritis
Other: Chronic endometritis
with or without Chronic endometritis
- Number of Participants With recurrence of adhesion in women with and without Chronic endometritis [ Time Frame: 1 year ]Second-look hysteroscopy was carried out in the early proliferative phase, 1 to 3 months after the initial operation.After assessment of the extent and severity of any reformed adhesions, hysteroscopic adhesiolysis was also carried out at the time of the second-look procedure, if adhesions had recurred.
- Reduction of American Fertility Society adhesion score at Second-look hysteroscopy between women with and without Chronic endometritis [ Time Frame: 1 year ]The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version) . A score of 1-4 was considered to represent mild adhesions, a score of 5-8 was considered to represent moderate adhesions and a score of 9-12 represented severe adhesions.
- Number of patients diagnosed with Chronic endometritis at hysteroscopy [ Time Frame: 1 year ]Chronic endometritis signs at hysteroscopy included  pedunculated and vascularized micro-polyps (<1 mm), most frequently found near the endocervical area (2); and  the presence of areas of hyperemic endometrium flushed with a white central point, localized or scattered throughout the cavity, referred to as "strawberry aspect".
- Number of patients with Chronic endometritis confirmed by histology [ Time Frame: 1 year ]Endometrial samples were fixed in neutral formalin and later embedded in paraffin for histological analysis. Five-micrometer sections were stained with hematoxilin-eosin. Histological diagnosis of Chronic endometritis: Attention was paid to the following features: superficial stromal edema, increased stromal density, pleomorphic stromal inflammatory infiltrate dominated by lymphocytes and plasma cells.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744807
|Principal Investigator:||chen yu qing, Deputy chief||The First Affiliated Hospital of SunYetSen University|