Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions

NCT02744807 | Completed DMC

• 1 other identifier: 2013B021800237
• Study Type: observational
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intrauterine Adhesions; Chronic Endometritis

Keywords

intrauterine adhesions; Chronic endometritis; infections; Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reduction of American Fertility Society adhesion score at Second-look hysteroscopy between women with and without Chronic endometritis

  1 year

• Number of patients diagnosed with Chronic endometritis at hysteroscopy

  1 year

• Number of patients with Chronic endometritis confirmed by histology

  1 year

Study Arms (2)

non-Chronic endometritis

patients with intrauterine adhesion only

Chronic endometritis

patients with intrauterine adhesion as well as Chronic endometritis

Other: Chronic endometritis

Interventions

Chronic endometritis OTHER

with or without Chronic endometritis

Chronic endometritis

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (3)

• 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.

  PMID: 26207958 BACKGROUND

• 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.

  PMID: 30922643 DERIVED

• 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.

  PMID: 27773811 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

endometrium

MeSH Terms

Conditions

Gynatresia; Infections

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• chen yu qing, Deputy chief

  The First Affiliated Hospital of SunYetSen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: April 20, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share