RCT(Randomized Clinical Trial ) of Antibiotic Therapy in Chronic Endometritis

NCT02648698 | Completed Results

• 1 other identifier: FuXingH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

120 cases with a diagnosis of chronic endometritis, confirmed by the presence of plasma cells in endometrial biopsy sample identified by immunohistochemical staining using CD138 antibody, have been recruited. The subjects have been randomly divided into two groups, the experimental group have been given antibiotic (Levofloxacin and Tinidazole for 14 days) treatment, the control group did not receive any antibiotic. Initially it was planned for women in the control group to take placebo,but the organization was difficult, so it was changed prior to the start of the study to an open label study. A repeat endometrial biopsy sample have been obtained 2-4 weeks after completion of the antibiotic therapy to assess the response to treatment. The conversion rate will be compared between the two groups

Conditions

Chronic Endometritis

Keywords

chronic endometritis; CD138; antibiotic; conversion rate.

Outcome Measures

Primary Outcomes (1)

• The Conversion Rate of CE (From Positive to Negative)

  Subjects in antibiotic group underwent a second-look hysteroscopy and repeat endometrial biopsy for histopathological CD138 immunohistochemical examination 2-4 weeks after completion of antibiotic treatment and in the follicular phase of the following menstrual cycle. Subjects in control group underwent a second-look hysteroscopy and repeat endometrial biopsy for histopathological CD138 immunohistochemical examination \~4 weeks after recruitment in the follicular phase of the following menstrual cycle. The biopsies were graded as "negative" for CE if there was less than one plasma cell identified per 10 high-power fields (HPFs) and "positive" when there was one or more plasma cell identified per 10 HPFs. To compare the cure rate (From positive to negative) of CE in women who received antibiotic therapy (treatment group) with the spontaneous cure rate in those who did not receive antibiotic therapy (control group),

  1-6 months

Study Arms (2)

Antibiotic group

EXPERIMENTAL

This group received antibiotic therapy

Drug: Antibiotics

Control group

NO INTERVENTION

This group did not receive antibiotic therapy

Interventions

Antibiotics DRUG

Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group

Also known as: Levofloxacin and Tinidazole

Antibiotic group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• CD138 immunohistochemical staining of endometrial specimen showed presence of one or more plasma cells per 10HPF which confirmed chronic endometritis, according to published criteria.
• women who were pre-menopausal.
• no evidence of endometrial hyperplasia or malignancy or structural uterine pathology.
• agreement to have a second endometrial biopsy \~4 weeks after the initial endometrial biopsy.
• written informed consent obtained

You may not qualify if:

• women who received steroid hormone therapy within one month of recruitment.
• allergy or suspected allergy to the chosen antibiotic therapy.
• women who developed any concurrent infection and received any antibiotic therapy during the period of study other than the one prescribed according to the study protocol.

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (1)

FuXing Hospital,Capital Medical University

Beijing, Beijing Municipality, 100038, China

Location

Related Publications (9)

• McQueen DB, Bernardi LA, Stephenson MD. Chronic endometritis in women with recurrent early pregnancy loss and/or fetal demise. Fertil Steril. 2014 Apr;101(4):1026-30. doi: 10.1016/j.fertnstert.2013.12.031. Epub 2014 Jan 23.

  PMID: 24462055 BACKGROUND

• Cicinelli E, Matteo M, Tinelli R, Pinto V, Marinaccio M, Indraccolo U, De Ziegler D, Resta L. Chronic endometritis due to common bacteria is prevalent in women with recurrent miscarriage as confirmed by improved pregnancy outcome after antibiotic treatment. Reprod Sci. 2014 May;21(5):640-7. doi: 10.1177/1933719113508817. Epub 2013 Oct 31.

  PMID: 24177713 BACKGROUND

• Kitaya K. Prevalence of chronic endometritis in recurrent miscarriages. Fertil Steril. 2011 Mar 1;95(3):1156-8. doi: 10.1016/j.fertnstert.2010.09.061. Epub 2010 Oct 28.

  PMID: 21030015 BACKGROUND

• Bayer-Garner IB, Nickell JA, Korourian S. Routine syndecan-1 immunohistochemistry aids in the diagnosis of chronic endometritis. Arch Pathol Lab Med. 2004 Sep;128(9):1000-3. doi: 10.5858/2004-128-1000-RSIAIT.

  PMID: 15335255 BACKGROUND

• Kannar V, Lingaiah HK, Sunita V. Evaluation of endometrium for chronic endometritis by using syndecan-1 in abnormal uterine bleeding. J Lab Physicians. 2012 Jul;4(2):69-73. doi: 10.4103/0974-2727.105584.

  PMID: 23440678 BACKGROUND

• Kitaya K, Yasuo T. Immunohistochemistrical and clinicopathological characterization of chronic endometritis. Am J Reprod Immunol. 2011 Nov;66(5):410-5. doi: 10.1111/j.1600-0897.2011.01051.x. Epub 2011 Jul 12.

  PMID: 21749546 BACKGROUND

• Cicinelli E, Matteo M, Tinelli R, Lepera A, Alfonso R, Indraccolo U, Marrocchella S, Greco P, Resta L. Prevalence of chronic endometritis in repeated unexplained implantation failure and the IVF success rate after antibiotic therapy. Hum Reprod. 2015 Feb;30(2):323-30. doi: 10.1093/humrep/deu292. Epub 2014 Nov 10.

  PMID: 25385744 BACKGROUND

• 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 RESULT

• Song D, He Y, Wang Y, Liu Z, Xia E, Huang X, Xiao Y, Li TC. Impact of antibiotic therapy on the rate of negative test results for chronic endometritis: a prospective randomized control trial. Fertil Steril. 2021 Jun;115(6):1549-1556. doi: 10.1016/j.fertnstert.2020.12.019. Epub 2021 Feb 3.

  PMID: 33549312 DERIVED

Related Links

• 2015
• 2014
• 2013 Oct 31
• 2011 Mar
• 2004 Sep
• 2012 Jul
• 2011 Jul 12
• 2015 Feb

MeSH Terms

Interventions

Anti-Bacterial Agents; Levofloxacin; Tinidazole

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

A possible limitation of our study is that patients were not blinded to the antibiotic treatment. A further limitation is the cure rate based on a repeat of test used to make the diagnosis, instead of pregnancy, miscarriage or live birth.

Results Point of Contact

• Title: Dr. Dongmei Song
• Organization: Department of Hysteroscopic Centre, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China

echosdm@163.com

13651294056

Study Officials

• Dongmei Song, Master

  FuXing Hospital,Capital Medical University

  PRINCIPAL INVESTIGATOR

• Enlan Xia, Master

  FuXing Hospital,Capital Medical University

  STUDY DIRECTOR

• Tinchiu Li, PhD

  FuXing Hospital,Capital Medical University

  STUDY CHAIR

• Xiaoxia Peng, PhD

  Capital Medical University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hysteroscopy Center

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 7, 2016
• Study Start: January 10, 2016
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: February 7, 2022
• Results First Posted: June 4, 2020

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)