Recurrent MiscarriageNCT06163092
Chronic Endometritis and Benefits of Antibiotics in Women With Recurrent Miscarriage
An observational study of Recurrent Miscarriage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Recurrent Miscarriage
- How many people
- 175 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2024to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Subjects will be identified and recruited from the miscarriage clinic by clinicians and research assistants and research nurse.
Who may be able to join
- Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation
- Women aged 20-45 years old
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
PUI WAH JACQUELINE CHUNG, MBBS, +852 35051537, jacquelinechung@cuhk.edu.hk
Stacey Wong, Bsc, +852 35051764, staceywong@cuhk.edu.hk
About this study
Official title: The Prevalence of Chronic Endometritis and Therapeutic Benefits of Antibiotics in Women With Unexplained Recurrent Miscarriage
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.
Read the detailed description
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.
- Conditions
- Recurrent Miscarriage
- Keywords
- chronic endometritis, antibiotics, unexplained recurrent miscarriage women
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
If the CE is high, antibiotics will be given to the patients as usual practice in hospitals.
| Study group | Role | What they receive |
|---|---|---|
| Observational study | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of chronic endometritis in local women with unexplained recurrent miscarriage
the incidence of chronic endometritis in local women with unexplained recurrent miscarriage
Measured: 31 January 2027
Secondary outcomes (2)
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
Measured: 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
Measured: 31 January 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Apr 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
- Investigators
- Jacqueline Pui Wah Chung, MBBS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163092
- Sponsor's protocol ID
- 2023.526
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Chronic Endometritis and Therapeutic Benefits of Antibiotics in Women With Unexplained Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT06163092
- Acronym / sponsor ID
- 2023.526
- Conditions
- Recurrent Miscarriage
- Keywords
- chronic endometritis, antibiotics, unexplained recurrent miscarriage women
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational study | – | –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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects will be identified and recruited from the miscarriage clinic by clinicians and research assistants and research nurse.
Key inclusion criteria (2 listed)
- Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation
- Women aged 20-45 years old
Key exclusion criteria (11 listed)
- Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural)
- Untreated hydrosalpinx
- Antiphospholipid syndrome
- Known clinical autoimmune disease
- Undergoing immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| If the CE is high, antibiotics will be given to the patients as usual practice in hospitals. | Other | Observational study |
Primary outcome
the incidence of chronic endometritis in local women with unexplained recurrent miscarriage
Time frame: 31 January 2027
the incidence of chronic endometritis in local women with unexplained recurrent miscarriage
2 secondary outcomes
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
Time frame: 31 January 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacqueline Pui Wah Chung, MBBS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Miscarriage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey Wong, BSc (35051764, staceywong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of chronic endometritis in local women with unexplained recurrent miscarriage (time frame: 31 January 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.