Actively Recruiting
The Prevalence of Chronic Endometritis and Therapeutic Benefits of Antibiotics in Women With Unexplained Recurrent Miscarriage
Led by Chinese University of Hong Kong · Updated on 2025-03-20
175
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine how often chronic endometritis (CE) occurs in women with unexplained recurrent miscarriage and to study the types of microorganisms involved in CE. It also investigates whether antibiotic treatments can help women who have CE and a history of multiple miscarriages. The study is observational and focuses on women aged 20 to 45 years with two or more consecutive miscarriages before 24 weeks of pregnancy. Women who join the study will undergo endometrial sampling during the mid-luteal phase, timed precisely seven days after their luteinizing hormone (LH) surge, detected by daily urine tests. The sample is collected using a Pipelle sampler during an outpatient visit. The tissue is analyzed for plasma cells, stromal cell changes, and infectious agents through microscopic and microbial tests. If CE is diagnosed, antibiotics are prescribed based on the infection type or given empirically, with treatment repeated up to three times if necessary. Participants will have repeat endometrial biopsies after antibiotic treatment to check for CE persistence. Researchers will monitor the incidence of CE, identify the microorganisms present, and compare pregnancy outcomes between women cured of CE and those without CE. The study involves outpatient procedures, laboratory tests, and clinical follow-ups, continuing until January 2027 to assess the therapeutic effects and pregnancy outcomes.
CONDITIONS
Brief Title
Chronic Endometritis and Benefits of Antibiotics in Women With Recurrent Miscarriage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation
- Women aged 20 to 45 years old
You will not qualify if you...
- Uncorrected uterine anomalies, such as 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 traditional Chinese medicine
- Currently or previously involved in other clinical trials with medication intake
- Those with active pelvic inflammatory disease or suspicion of infection etc.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 1 menstrual cycle
Participants undergo endometrial sampling (ES) using a Pipelle sampler as an outpatient procedure to diagnose chronic endometritis.
1 outpatient visit for endometrial sampling precisely 7 days after LH surge
Duration - Up to 3 courses of 14 days each
Participants diagnosed with chronic endometritis receive antibiotic treatment based on microbial culture results or empirical therapy with doxycycline. Endometrial biopsy will be repeated after antibiotic treatment to assess cure. Additional antibiotic courses may be given if CE persists, up to three courses depending on participant willingness.
1 to 4 outpatient visits for antibiotic treatment and repeated biopsies depending on response
Duration - Up to 1 year
Participants are observed for pregnancy outcomes and resolution of chronic endometritis after treatment.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
S
Stacey Wong, BSc
J
Jacqueline Pui Wah Chung, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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