Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-11-30
Brief Title:
Chronic Endometritis and Benefits of Antibiotics in Women With Recurrent Miscarriage
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
The Prevalence of Chronic Endometritis and Therapeutic Benefits of Antibiotics in Women With Unexplained Recurrent Miscarriage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None