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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06163092
Other study ID # 2023.526
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date January 31, 2027

Study information

Verified date February 2024
Source Chinese University of Hong Kong
Contact Stacey Wong, BSc
Phone 35051764
Email staceywong@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 175
Est. completion date January 31, 2027
Est. primary completion date January 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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.

Study Design


Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of chronic endometritis in local women with unexplained recurrent miscarriage the incidence of chronic endometritis in local women with unexplained recurrent miscarriage 31 January 2027
Secondary 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 31 January 2027
Secondary 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 31 January 2027
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