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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective, Randomized, Placebo-controlled Trial on the Effect of Antibiotic Therapy on Endometrial Response in Women With Chronic Endometritis

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

Detailed Summary:

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
Sponsor: Fu Xing Hospital, Capital Medical University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Fu Xing Hospital, Capital Medical University

Dates:
Date Received: December 23, 2015
Date Started: January 2016
Date Completion: March 2017
Last Updated: July 31, 2016
Last Verified: July 2016