Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions

Chronic Endometritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744807
• Other study ID #: 2013B021800237
• Status: Completed
• Phase: N/A
• First received: April 10, 2016
• Last updated: April 15, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Endometritis
• Endometritis
• Intrauterine Adhesions
• Tissue Adhesions

Intervention

Other:
• Chronic endometritis
with or without Chronic endometritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

References & Publications (1)

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):927-31. doi: 10.1016/j.fertnstert.2015.06.044. Epub 2015 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes