Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02744807

Collaborator

(none)

125

Enrollment

9.1

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Adhesions Chronic Endometritis	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 Design

Study Type:

Observational

Actual Enrollment :

125 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Number of Participants With recurrence of adhesion in women with and without Chronic endometritis [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.

Secondary Outcome Measures

Reduction of American Fertility Society adhesion score at Second-look hysteroscopy between women with and without Chronic endometritis [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) [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.
Number of patients diagnosed with Chronic endometritis at hysteroscopy [1 year]
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".
Number of patients with Chronic endometritis confirmed by histology [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.