Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions

Prevalence of Chronic Endometritis in Severe Intrauterine Adhesions and Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine

This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without CE.

Study Overview

• Status: Completed
• Conditions: Chronic Endometritis; Intrauterine Adhesions
• Intervention / Treatment: Other: Chronic endometritis

Detailed Description

Chronic endometritis (CE) is a persistent in endometrium that is characterized by the presence of plasma cells. Recently, there has been increasing interest in the role of CE in recurrent pregnancy loss (RPL). One of the most common uterine abnormalities for RPL is Intrauterine adhesion (IUA).Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health.It is well established that the formation of IUA likely involves hypoxia, reduced neovascularization, and altered expression of adhesion-associated cytokines, but the exact mechanisms are not well understood. Although excessive curettage is considered the primary cause, intrauterine adhesion is known to be associated with diverse non-traumatic factors, such as postabortal sepsis, puerperal sepsis and infections. It is therefore possible to hypothesize that Intrauterine adhesion may be related to chronic endometritis. To the best of researchers knowledge,there have been no reports investigating this relationship. The aim of this study was to clarify the hypothesis by evaluating the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without chronic endometritis (CE).

• Study Type: Observational
• Enrollment (Actual): 125

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

A total of 125 patients who received hysteroscopy in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Sun Yat-sen University and were diagnosed with moderate to severe Intrauterine adhesion according to the criteria of American Fertility Society (AFS) were recruited into present study.

Description

Inclusion Criteria:

• Pre-operative adhesion score was ≥5
• The prior menstrual cycle was regular, and the sex hormone was normal
• with informed consent
• absence of other uterine abnormality at transvaginal ultrasound
• There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery.

Exclusion Criteria:

• Pre-operative adhesion score was <5
• Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
• other uterine abnormality at transvaginal ultrasound
• without informed consent
• Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma
• refuse Endometrial biopsy
• Vaginal discharge abnormal, or Suspected vaginitis or pelvic inflammatory disease, or using antibiotics.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-Chronic endometritis; patients with intrauterine adhesion only
Chronic endometritis; patients with intrauterine adhesion as well as Chronic endometritis	Other: Chronic endometritis; with or without Chronic endometritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With recurrence of adhesion in women with and without Chronic endometritis	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of American Fertility Society adhesion score at Second-look hysteroscopy between women with and without Chronic endometritis	The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version) [7]. 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.	1 year
Number of patients diagnosed with Chronic endometritis at hysteroscopy	Chronic endometritis signs at hysteroscopy included [1] pedunculated and vascularized micro-polyps (<1 mm), most frequently found near the endocervical area (2); and [2] the presence of areas of hyperemic endometrium flushed with a white central point, localized or scattered throughout the cavity, referred to as "strawberry aspect".	1 year
Number of patients with Chronic endometritis confirmed by histology	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.	1 year

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: chen yu qing, Deputy chief, the First Affiliated Hospital of SunYetSen University

Publications and helpful links

General Publications

• McQueen DB, Perfetto CO, Hazard FK, Lathi RB. Pregnancy outcomes in women with chronic endometritis and recurrent pregnancy loss. Fertil Steril. 2015 Oct;104(4):927-931. doi: 10.1016/j.fertnstert.2015.06.044. Epub 2015 Jul 21.
• Liu L, Yang H, Guo Y, Yang G, Chen Y. The impact of chronic endometritis on endometrial fibrosis and reproductive prognosis in patients with moderate and severe intrauterine adhesions: a prospective cohort study. Fertil Steril. 2019 May;111(5):1002-1010.e2. doi: 10.1016/j.fertnstert.2019.01.006. Epub 2019 Mar 25.
• Chen Y, Liu L, Luo Y, Chen M, Huan Y, Fang R. Prevalence and Impact of Chronic Endometritis in Patients With Intrauterine Adhesions: A Prospective Cohort Study. J Minim Invasive Gynecol. 2017 Jan 1;24(1):74-79. doi: 10.1016/j.jmig.2016.09.022. Epub 2016 Oct 20.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: April 10, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: infections; Hysteroscopy; intrauterine adhesions; Chronic endometritis
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Disease Attributes; Adnexal Diseases; Fibrosis; Cicatrix; Pelvic Inflammatory Disease; Recurrence; Tissue Adhesions; Endometritis
• Other Study ID Numbers: 2013B021800237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes