Clinical trial NCT02744807: Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions
Official title: Prevalence of Chronic Endometritis in Severe Intrauterine Adhesions and Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Adhesions
Chronic Endometritis
Keywords: intrauterine adhesions
Chronic endometritis
infections
Hysteroscopy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 125
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With recurrence of adhesion in women with and without Chronic endometritis
timeFrame: 1 year
Secondary outcomes:
measure: Reduction of American Fertility Society adhesion score at Second-look hysteroscopy between women with and without Chronic endometritis
timeFrame: 1 year
measure: Number of patients diagnosed with Chronic endometritis at hysteroscopy
timeFrame: 1 year
measure: Number of patients with Chronic endometritis confirmed by histology
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of SunYetSen University
name: chen yu qing, Deputy chief
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.