Levofloxacin Plus Metronidazole Suppositories Versus Levofloxacin Co-administered with Metronidazole Tablets in Chronic Endometritis

NCT06650540 | Not Yet Recruiting DMC

• 2 other identifiers: RCT of chronic endometritisNo. BYSY2023022
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single randomised controlled trial. The investigators plan to randomise 800 participants to the levofloxacin plus metronidazole suppositories versus levofloxacin co-administered with metronidazole tablets for the treatment of chronic endometritis in a 1:1 rate. Primary outcome will be the live birth rate after the embryo transfer.

Conditions

IVF

Keywords

Chronic Endometritis; pregnancy outcomes; pharmacological treatment

Outcome Measures

Primary Outcomes (1)

• live birth rate after the first embryo transfer

  Live birth is defined as the delivery of at least one baby after 22 weeks of gestation Oversight that exhibits any sign of life.

  22 weeks to 43 weeks gestation after the first embryo transfer cycle

Secondary Outcomes (15)

• Clinical pregnancy

  around 7 weeks' gestation after the first embryo transfer cycle

• Ongoing pregnancy

  12 weeks to 43weeks gestation after the first embryo transfer cycle

• Biochemical pregnancy

  about 14 days after embryo transfer

• Miscarriage

  6-22 weeks of gestation

• Cumulative live birth

  6 monti after the first embryo transfer

Study Arms (2)

Levofloxacin Plus Metronidazole Suppositories group

EXPERIMENTAL

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

Drug: Levofloxacin Plus Metronidazole Suppositories

Levofloxacin co-administered with Metronidazole tablets group

ACTIVE COMPARATOR

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

Biological: Levofloxacin co-administered with Metronidazole tablets

Interventions

Levofloxacin Plus Metronidazole Suppositories DRUG

Administer a two-week course of Levofloxacin Plus Metronidazole Suppositories to patients diagnosed with chronic endometritis.

Also known as: Experimental

Levofloxacin Plus Metronidazole Suppositories group

Levofloxacin co-administered with Metronidazole tablets BIOLOGICAL

Administer a two-week course of Levofloxacin in combination with Metronidazole tablets to patients diagnosed with chronic endometritis.

Also known as: Active Comparator

Levofloxacin co-administered with Metronidazole tablets group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Agree and sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking university third hospital

Beijing, 100191, China

Location

Related Publications (1)

• Lin M, Wang Y, Lv X, Lin Z, Zeng Z, Mo D, Shan H, Li R. Administration of levofloxacin combined with metronidazole suppositories prior to in vitro fertilisation in women with chronic endometritis: a protocol of a single-centre, randomised, controlled clinical trial. BMJ Open. 2025 Sep 15;15(9):e098500. doi: 10.1136/bmjopen-2024-098500.

  PMID: 40954081 DERIVED

MeSH Terms

Interventions

Levofloxacin; Metronidazole

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Ming Mei Lin, MD

CONTACT

18500196527; linmingmei2023@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: October 22, 2024
• Primary Completion: October 22, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: the day of publishing the main results, Around 3 years from now
• Access Criteria: please contact the hukailun@bjmu.edu and linmingmei2023@163.com

Locations

CN (1)