Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

NCT ID: NCT05613049

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 720 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2028-01-31

Brief Summary

The aim of the study is to investigate the confounding factors of chronic endometritis and therapeutic benefits of antibodies targeting plasma cells in women with reproductive failure.

Detailed Description

Eligible women, based on the inclusion and exclusion criteria, will be recruited from the IVF and/ or miscarriage clinic in the Prince of Wales Hospital/ CUHK medical centre (CUMC). 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. In artificial cycles, 6mg estradiol will be given daily orally from day 2 of the menstrual cycle for 14+/-1-2 days. Transvaginal ultrasound will be performed on day 14 of the estrogen therapy to assess the endometrial thickness and to exclude ovarian activity. If endometrial thickness is ≥8 mm, plasma progesterone level is < 4nmol/L, progesterone will be commenced using either Endometrin (Ferring, Saint-Prex, Switzerland) 100 mg TDS vaginally. ES will be obtained using a Pipelle sampler as an outpatient procedure. The ES will be obtained precisely 5 days after progesterone supplementation.

Immunohistochemical staining will be used to determine plasma cells by using a mouse antihuman monoclonal primary anti-CD138 antibody and anti-CD38 antibody. The total number of plasma cell present in the stroma of the entire specimen will be determined and expressed as plasma cell count per unit area of the specimen. If CE is present, antibiotics will be given following the guideline from the Hospital Authority (HA). Then ES will be taken again to be re-examined by histology and microbiology.

Conditions

IVF

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational group

Patients have 2 or more miscarriage or repeated implantation failure (RIF), or infertile women would be invited to do endometrial sampling (ES) procedure. The ES will be conducted randomly or when women undergo hysteroscopy or obtained precisely 7 days after LH surge. It will be obtained using a Pipelle sampler as an outpatient procedure.

Intervention Type: OTHER

If the CE is high, antibiotics will be given to the patients as usual practice in hospitals.

Interventions

If the CE is high, antibiotics will be given to the patients as usual practice in hospitals.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 20-45 years;

2. Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation12; or

3. Women who failed to conceive after unprotected intercourse for one year; or

4. Women who failed failure to achieve a clinical pregnancy after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos is no less than four for day-2 embryos and no less than 2 for day-5 embryos (blastocysts), with all embryos being of good quality.

Exclusion Criteria

1. Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural);

2. Untreated hydrosalpinx;

3. History of antiphospholipid syndrome;

4. Known clinical autoimmune disease;

5. Undergoing immunotherapy;

6. Abnormal thyroid function;

7. Abnormal karyotyping.

8. Those with active pelvic inflammatory disease or suspicion of infection etc.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Chung Pui Wah Jacqueline

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacqueline Pui Wah Chung, MBBS

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Stacey Wong, BSc

Role: CONTACT

staceywong@cuhk.edu.hk

35051764

JacquelinePui Wah Chung, MBBS

Role: CONTACT

jacquelinechung@cuhk.edu.hk

35051764

Facility Contacts

PUI WAH JACQUELINE CHUNG, MBBS

Role: primary

jacquelinechung@cuhk.edu.hk

+852 35051537

Stacey Wong, Bsc

Role: backup

staceywong@cuhk.edu.hk

+852 35051764

Other Identifiers

2022.339

Identifier Type: -

Identifier Source: org_study_id