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

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ClinicalTrials.gov Identifier: NCT02648698
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Song Dongmei, Fu Xing Hospital, Capital Medical University

Brief Summary:
82 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, will be recruited. The subjects will be randomly divided into two groups, the experimental group will be given antibiotic (Augmentin) treatment, the control group will be given placebo. A repeat endometrial biopsy sample will be obtained one month after completion of the antibiotic therapy to assess the response to treatment. The cure rate will be compared between the two groups

Condition or disease Intervention/treatment Phase
Chronic Endometritis Drug: Antibiotics Not Applicable

Detailed Description:

This study will be carried out at the Hysteroscopy centre of the Fuxing Hospital, Beijing, China. A total of 82 women with chronic endometritis who fulfilled the following inclusion criteria will be recruited:

  1. Pre-menopausal
  2. Agreed to have repeat hysteroscopy and a second endometrial biopsy ~4 weeks after the first hysteroscopy and endometrial biopsy
  3. No evidence of hyperplasia or cancer in the initial endometrial biopsy

Exclusion Criteria:

  1. steroid hormone therapy within the preceding one month of recruitment
  2. Allergy to antibiotic
  3. Concurrent infection which require additional courses of antibiotic therapy before the second endometrial biopsy specimen.

Power calculation: assuming that the spontaneous CD138 conversion (from +ve to -ve) rate is 25% and that the antibiotic therapy results in 60% conversion rate, the total number of subjects required in each arm of the RCT will be 37, accepting a Type I error of 0.05 and a Type II error of 0.1. Assuming a drop-out rate of 10%, 41 subjects will need to be recruited into each arm. Hence, a total of 82 subjects who fulfilled the inclusion criteria will be required.

Recruitment: Women will be recruited form the day case hysteroscopy unit of the Hysteroscopy center, Fuxing Hospital, Beijing, China. The Hysteroscopy center currently carries out ~600 day case hysteroscopy per month. In all cases, endometrial biopsy specimen will be obtained at the time of hysteroscopy for histological evaluation. Since 2013, all endometrial specimens have been routinely examined with the used of CD138 antibody to establish if there is evidence of chronic endometritis, in addition to routine histopathological examination. Previous audit showed that ~15% of subjects had positive staining for CD138 cells. In addition, it is estimated that about 1/5 of subjects undergoing hysteroscopy and biopsy will fulfill the inclusion criteria. Assuming a successful recruitment rate of 75% among those who are eligible, the total number of subjects to be screened will be 3,650 in order to successfully recruit 82 subjects. Given that we carry out ~600 hysteroscopy per month, the recruitment will take ~6-9 months.

Randomization: computer generated Antibiotic therapy: Staff Pharmacist will dispense medication; placebo will consist of vitamin C tablet Consent: written informed consent will be obtained Repeat endometrial biopsy & histological evaluation: The repeat endometrial biopsy will be performed after completion of the the antibiotic therapy. Immunohistochemical study using CD138 antibody will be performed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Placebo-controlled Trial on the Effect of Antibiotic Therapy on Endometrial Response in Women With Chronic Endometritis
Study Start Date : January 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Antibiotic group
This group received antibiotic therapy
Drug: Antibiotics
Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group
Other Name: Levofloxacin and Tinidazole

No Intervention: Control group
This group did not receive antibiotic therapy



Primary Outcome Measures :
  1. The negative rate of the two groups in CD138 positive patients with and without treatment [ Time Frame: six months ]
    patients with positive of CD138 treated by antibiotic were followed for how many patients transform negative in CD138


Secondary Outcome Measures :
  1. Live birth rate of patients with CD138 positive and negative [ Time Frame: one year ]
    To follow up the live birth rate in patients with CD138 positive and negative after antibiotic treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pre-menopausal
  2. Agreed to have repeat hysteroscopy and a second endometrial biopsy ~4 weeks after the first hysteroscopy and endometrial biopsy
  3. No evidence of hyperplasia or cancer in the initial endometrial biopsy

Exclusion Criteria:

  1. Steroid hormone therapy within the preceding one month of recruitment
  2. Allergy to antibiotic
  3. Concurrent infection which require additional courses of antibiotic therapy before the second endometrial biopsy specimen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648698


Locations
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China, Beijing
FuXing Hospital,Capital Medical University
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Fu Xing Hospital, Capital Medical University
Investigators
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Principal Investigator: Dongmei Song, Master FuXing Hospital,Capital Medical University
Study Director: Enlan Xia, Master FuXing Hospital,Capital Medical University
Study Chair: Tinchiu Li, PhD FuXing Hospital,Capital Medical University
Study Director: Xiaoxia Peng, PhD Capital Medical University

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Song Dongmei, Hysteroscopy Center, Fu Xing Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT02648698     History of Changes
Other Study ID Numbers: FuXingH
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Song Dongmei, Fu Xing Hospital, Capital Medical University:
chronic endometritis
CD138
Additional relevant MeSH terms:
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Endometritis
Anti-Bacterial Agents
Antibiotics, Antitubercular
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Levofloxacin
Ofloxacin
Tinidazole
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Alkylating Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents