Chronic Endometritis and Benefits of Antibiotics in Women With Recurrent Miscarriage

NCT06163092 | Recruiting DMC

• 1 other identifier: 2023.526
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Miscarriage

Keywords

chronic endometritis; antibiotics; unexplained recurrent miscarriage women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Investigate the spectrum of endometrial microorganisms associated with chronic endometritis in this population

  31 January 2027

• Assess the clinical pregnancy outcomes between cured CE group and non-CE group

  31 January 2027

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Please kindly see the inclusion criteria. The endometrics sampling is only done for female patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be identified and recruited from the miscarriage clinic by clinicians and research assistants and research nurse.

You may qualify if:

• Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation
• Women aged 20-45 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jacqueline Pui Wah Chung, MBBS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey Wong, BSc

CONTACT

35051764; staceywong@cuhk.edu.hk

Jacqueline Pui Wah Chung, MBBS

CONTACT

35051764; jacquelinechung@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: April 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)