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Levofloxacin with Metronidazole Suppositories for Chronic Endometritis

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What is being tested

Levofloxacin Plus Metronidazole Suppositories

+ Levofloxacin co-administered with Metronidazole tablets

DrugBiological
Who is being recruted

From 20 to 42 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorPeking University Third Hospital
Study ContactMing Mei Lin, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2024

Actual date on which the first participant was enrolled.

Chronic endometritis is a condition where the lining of the uterus becomes inflamed, often due to infections. This inflammation can lead to difficulties in getting pregnant, miscarriages, and issues with carrying a pregnancy to term. Current treatments usually involve taking antibiotics by mouth, but these can have side effects like nausea and skin rashes, and sometimes they don't work as well as hoped. This study is looking at whether treating the condition with a combination of levofloxacin and metronidazole in different forms might be more effective. The researchers are testing if using metronidazole as a suppository, which is inserted into the vagina, can deliver the medicine more directly to the problem area and improve pregnancy outcomes for women with this condition. In this study, participants are randomly assigned to receive either the standard treatment of oral levofloxacin and metronidazole tablets or a combination of levofloxacin with metronidazole suppositories. The focus is on women aged 20 to 42 who have been diagnosed with chronic endometritis through specific medical procedures. By comparing the pregnancy success rates between these two groups, the study aims to find a better treatment method that could help improve the chances of getting pregnant and having a successful birth. Participants need to have certain health criteria met, and those with other specific medical conditions or allergies to the medications used are not included in the study.

Official TitleLevofloxacin Plus Metronidazole Suppositories Versus Levofloxacin Co-administered with Metronidazole Tablets for the Treatment of Chronic Endometritis: a Randomized Controlled Trial
NCT06650540
Principal SponsorPeking University Third Hospital
Study ContactMing Mei Lin, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

800 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 42 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Infertile patients aged 20-42 years

Hysteroscopy and endometrial biopsy were performed, and the

Pathological diagnosis was chronic endometritis

Serum FSH level on the second day of menstruation was ≤12U/L

Show More Criteria

3 exclusion criteria prevent from participating
Patients with the following diagnoses: submucosal myoma; Uterine malformation or previous surgery for correction of uterine deformity; Intrauterine adhesions; The previous history of pelvic tuberculosis or endometrial tuberculosis or the current pathology suggested endometrial tuberculosis; Endometrial hyperplasia or endometrial cancer

Patients with spouse, previous fetal or child chromosomal abnormalities who plan to undergo preimplantation genetic screening

Patients with a history of allergy to study drugs

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Clinical pregnancy outcomes of the first embryo transfer in patients with chronic endometritis treated with Levofloxacin Plus Metronidazole Suppositories.

Group II

Active Comparator
Clinical pregnancy outcomes after the first embryo transfer in patients with chronic endometritis treated with Levofloxacin co-administered with Metronidazole tablets.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Peking university third hospital

Beijing, ChinaOpen Peking university third hospital in Google Maps
Recruiting soonOne Study Center