An observational study in Recurrent Miscarriage, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Chinese University of Hong Kong · Observational
The aim of the study is to estimate the incidence of CE, evaluate the endometrial microorganism of CE, and investigate the therapeutic benefits of antibiotics for women with unexplained recurrent miscarriage and CE.
Eligible women, based on the inclusion and exclusion criteria, will be recruited from the miscarriage clinic in the Prince of Wales Hospital. Endometrial sampling (ES) will alternatively be conducted during mid-luteal phase. In natural cycles, all the subjects will have a daily urine test from day 9 of the menstrual cycle to identify the Luteinizing Hormone (LH) surge. The ES will be obtained precisely 7 days after LH surge. Endometrial samples will be obtained using a Pipelle sampler as an outpatient procedure. The endometrium will be divided into three aliquots. One will be fixed in 4% formalin for 24 hours, routinely processed and embedded in paraffin wax. One will be investigated by microbial culture for infectious agents and one will be sequenced to reveal the endometrial microbiota.
CE will be diagnosed either by the presence of plasma cells and changes in endometrial stromal cells identified using HE and IHC, or by the finding of infectious agents using microbial culture. The selection of antibiotics will be based on the type of infectious agents or empirical, doxycycline 100mg BD po. for 14 days, for women with negative microbial culture. Endometrial biopsy will be repeated at the same time point after antibiotic treatment for women with CE. For persistent subjects with negative culturing, ciprofloxacin 500mg, BD po., and metronidazole 400mg TDS po. for 14 days will be used. The treatment will be repeated for three courses at maximum for women with persistent CE according to their willingness.
102 studies on the registry are indexed under Abortion, Habitual; 21 are open to participants now.
This study's planned enrollment of 175 is close to the median of 161 across 44 observational studies indexed under Abortion, Habitual.
Browse Abortion, Habitual studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be identified and recruited from the miscarriage clinic by clinicians and research assistants and research nurse.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with recurrent miscarriage would be invited to do endometrial sampling (ES) procedure. The ES will be conducted precisely 7 days after LH surge. It will be obtained using a Pipelle sampler as an outpatient procedure.
the incidence of chronic endometritis in local women with unexplained recurrent miscarriage
the incidence of chronic endometritis in local women with unexplained recurrent miscarriage
Time frame: 31 January 2027
Investigate the spectrum of endometrial microorganisms associated with chronic endometritis in this population
Investigate the spectrum of endometrial microorganisms associated with chronic endometritis in this population
Time frame: 31 January 2027
Assess the clinical pregnancy outcomes between cured CE group and non-CE group
Assess the clinical pregnancy outcomes in both cured CE group and non-CE group
Time frame: 31 January 2027
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Jan 2026, 21 months after the start.
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Chinese University of Hong Kong →