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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Endometritis||Drug: Antibiotics||Not Applicable|
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:
- Agreed to have repeat hysteroscopy and a second endometrial biopsy ~4 weeks after the first hysteroscopy and endometrial biopsy
- No evidence of hyperplasia or cancer in the initial endometrial biopsy
- steroid hormone therapy within the preceding one month of recruitment
- Allergy to antibiotic
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Single Group Assignment|
|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|
Experimental: Antibiotic group
This group received antibiotic therapy
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
- 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
- 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
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
|FuXing Hospital,Capital Medical University|
|Beijing, Beijing, China, 100038|
|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|