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A Single-Center, Open-Label, Randomized Controlled Study on the Improvement of Reproductive Tract Microbiota and Clinical Outcomes in Patients with Chronic Endometritis through the Combination of Antibiotics and Oral Lactobacillus GR-1 & RC-14

A Single-Center, Open-Label, Randomized Controlled Study on the Improvement of Reproductive Tract Microbiota and Clinical Outcomes in Patients with Chronic Endometritis through the Combination of Antibiotics and Oral Lactobacillus GR-1 & RC-14

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101908
Enrollment
Unknown
Registered
2025-05-06
Start date
2025-05-06
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Endometritis

Interventions

Antibiotic Treatment:Daily oral antibiotics for 2 weeks
Antibiotic Treatment + Probiotics Group:Daily oral antibiotics for 2 weeks, followed by direct consumption or oral intake of probiotics with room-temperature water, 1 sachet/day, for a total of 4 week

Sponsors

Guangdong Women and Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 42 Years

Inclusion criteria

Inclusion criteria: (1) Age range: 20-42 years old; (2) AMH > 1.1 ng/ml, menstrual cycle 25-37 days, relatively regular; (3) Diagnosis of chronic endometritis: typical hysteroscopic findings of chronic endometritis or pathological CD138 >= 5 cells/HPF; (4) Agree to participate in the study and sign the informed consent form: understand the study procedures and voluntarily participate.

Exclusion criteria

Exclusion criteria: (1) Recent antibiotic treatment: patients who have received antibiotic treatment within the past month, as it may affect the efficacy of probiotics. (2) Recent use of probiotics: patients who have used probiotics within the past two months, to exclude interference from other probiotics. (3) Severe gynecological inflammation or other reproductive system diseases: such as acute pelvic inflammatory disease, severe untreated hydrosalpinx, etc., which may interfere with study results. (4) Significant liver or kidney dysfunction: as hepatic or renal insufficiency may affect the metabolism of drugs and probiotics. (5) Allergy to probiotics or other drugs used in the study. (6) Exclusion of recurrent miscarriage or repeated implantation failure.

Design outcomes

Primary

MeasureTime frame
Clinical Pregnancy Rate After the First Embryo Transfer;

Secondary

MeasureTime frame
Cure Rate of Chronic Endometritis;Differences in the composition of microbial communities in different parts of the reproductive tract in CE patients.;The impact of different treatment methods on the composition of the reproductive tract microbiota.;The correlation between the impact of different treatment modalities on the reproductive tract microbiota and clinical outcomes.;Identify microbial biomarkers significantly associated with CE (Chronic Endometritis).;To reveal how different treatment modalities regulate endometritis through microbe-host interactions using multi-omics integrated analysis.;The impact of different treatment methods on the diversity of the reproductive tract microbiota.;The impact of different treatment methods on the abundance of the reproductive tract microbiota.;Differences in the functionality of microbial communities in different parts of the reproductive tract in CE patients.;

Countries

China

Contacts

Public ContactFenghua Liu

Reproductive medicine center of Guangdong Women and Children Hospital

liushine2006@163.com+86 139 2647 8318

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026