Exploring the Role of Antibiotics in Women with Recurrent Miscarriage and Chronic Endometritis
The Prevalence of Chronic Endometritis and Therapeutic Benefits of Antibiotics in Women With Unexplained Recurrent Miscarriage
This study is testing if antibiotics can help women with unexplained recurrent miscarriages who also have chronic endometritis by checking for infections and seeing how well the treatment works.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06163092 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the incidence of chronic endometritis (CE) in women experiencing unexplained recurrent miscarriage. Eligible participants will undergo endometrial sampling during their menstrual cycle to evaluate the presence of microorganisms associated with CE. The study will also investigate the therapeutic benefits of antibiotics, with treatment tailored based on the identified infectious agents or empirical protocols. Follow-up endometrial biopsies will assess the effectiveness of the antibiotic treatment.
Who should consider this trial
Good fit: Ideal candidates include women aged 20-45 with a history of two or more consecutive miscarriages before 24 weeks of gestation.
Not a fit: Patients with uncorrected uterine anomalies, active pelvic inflammatory disease, or those currently taking other antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatments for women suffering from recurrent miscarriages linked to chronic endometritis.
How similar studies have performed: While the approach of using antibiotics for chronic endometritis in the context of recurrent miscarriage is relatively novel, similar studies have shown promising results in addressing endometrial infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation * Women aged 20-45 years old Exclusion Criteria: * Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural) * Untreated hydrosalpinx * Antiphospholipid syndrome * Known clinical autoimmune disease * Undergoing immunotherapy * Abnormal thyroid function * Abnormal karyotyping of couples * Known immunodeficiency pathologies such as diabetes or HIV * Currently taking other antibiotics or other trial medications or TCM; * Currently or previously involved in other clinical trials with medication intake; * Those with active pelvic inflammatory disease or suspicion of infection etc.
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Jacqueline Pui Wah Chung, MBBS — Chinese University of Hong Kong
- Study coordinator: Stacey Wong, BSc
- Email: staceywong@cuhk.edu.hk
- Phone: 35051764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.