Trial Outcomes & Findings for RCT(Randomized Clinical Trial ) of Antibiotic Therapy in Chronic Endometritis (NCT NCT02648698)

Last Updated: 2022-02-07

Results Overview

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),

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

1-6 months

Results posted on

2022-02-07

Participant Flow

A total of 120 subjects were assessed for eligibility. All of the 120 subjects were enrolled and randomized into the antibiotic group and the control group on a 1:1 ratio.

Participant milestones

Participant milestones
Measure	Antibiotic Group This group received antibiotic therapy Antibiotics: Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group	Control Group This group did not receive antibiotic therapy
Overall Study STARTED	60	60
Overall Study COMPLETED	59	55
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Antibiotic Group This group received antibiotic therapy Antibiotics: Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group	Control Group This group did not receive antibiotic therapy
Overall Study Protocol Violation	1	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiotic Group n=60 Participants This group received antibiotic therapy Antibiotics: Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group	Control Group n=60 Participants This group did not receive antibiotic therapy	Total n=120 Participants Total of all reporting groups
Age, Continuous	31.86 years STANDARD_DEVIATION 4.7 • n=5 Participants	31.93 years STANDARD_DEVIATION 4.8 • n=7 Participants	31.89 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	59 participants n=5 Participants	55 participants n=7 Participants	114 participants n=5 Participants
BMI	22.91 kg/m^2 STANDARD_DEVIATION 3.4 • n=5 Participants	22.28 kg/m^2 STANDARD_DEVIATION 3.5 • n=7 Participants	22.61 kg/m^2 STANDARD_DEVIATION 3.4 • n=5 Participants
Parity	2.15 events STANDARD_DEVIATION 0.9 • n=5 Participants	2.15 events STANDARD_DEVIATION 0.9 • n=7 Participants	2.15 events STANDARD_DEVIATION 0.9 • n=5 Participants
Miscarriage	1.59 events STANDARD_DEVIATION 1.0 • n=5 Participants	1.93 events STANDARD_DEVIATION 1.0 • n=7 Participants	1.75 events STANDARD_DEVIATION 1.0 • n=5 Participants

PRIMARY outcome

Timeframe: 1-6 months

Outcome measures

Outcome measures
Measure	Antibiotic Group n=59 Participants This group received antibiotic therapy Women who were randomized to the treatment group were given oral Levofloxacin 500 mg and Tinidazole 1000 mg daily for 14 days.	Control Group n=55 Participants Women who were randomized to the control group did not receive any antibiotic.
The Conversion Rate of CE (From Positive to Negative)	89.8 Percentage of participants Interval 82.2 to 97.5	12.7 Percentage of participants Interval 3.9 to 21.5

Adverse Events

Antibiotic Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dongmei Song

Department of Hysteroscopic Centre, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China

Phone: 13651294056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place