Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

NCT05613049 | Recruiting DMC

• 1 other identifier: 2022.339
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF

Keywords

chronic endometritis; confounding factors; reproductive failure; infertility; IVF; infertility women

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  compare the brith rate between the group and cohort

  31 December 2027

Secondary Outcomes (3)

• Compare the pregnancy rate between groups

  31 March 2028

• Compare the miscarriage rate between groups

  31 March 2028

• Compare the implantation rate between groups

  31 March 2028

Study Arms (1)

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.

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 IVF and miscarriage clinic by clinicians and research nurse.

You may qualify if:

• Age 20-45 years;
• Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation12; or
• Women who failed to conceive after unprotected intercourse for one year; or
• 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.

You may not qualify if:

• Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural);
• Untreated hydrosalpinx;
• History of antiphospholipid syndrome;
• Known clinical autoimmune disease;
• Undergoing immunotherapy;
• Abnormal thyroid function;
• Abnormal karyotyping.
• 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

Biospecimen

Retention: NONE RETAINED

Patient will be invited to do endometrial sampling

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; 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

JacquelinePui 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 3, 2022
• First Posted: November 14, 2022
• Study Start: January 26, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)