Actively Recruiting

Age: 20Years - 45Years
FEMALE
ID05613049

Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

Led by Chinese University of Hong Kong · Updated on 2025-03-27

720

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore the factors that may confuse the diagnosis of chronic endometritis and to evaluate the potential benefits of antibodies that target plasma cells in women experiencing reproductive failure. The study focuses on women who have had repeated miscarriages, failed to conceive after a year, or faced implantation failure during IVF treatments. The study is observational and is conducted at specialized reproductive health clinics. Participants will undergo endometrial sampling during the mid-luteal phase of their menstrual cycle. In natural cycles, urine tests will track the luteinizing hormone surge to time the sampling precisely seven days later. In artificial cycles, estradiol medication is given to prepare the uterus, followed by progesterone supplementation if specific criteria are met. Endometrial samples are collected using a Pipelle sampler during outpatient visits. If chronic endometritis is detected, antibiotics will be administered following hospital guidelines, and a follow-up sample will be taken to assess treatment response. Throughout the study, women will have their plasma cell levels in the endometrium measured using immunohistochemical staining. Researchers will track important outcomes such as live birth rates and compare pregnancy, miscarriage, and implantation rates across groups. The study includes thorough monitoring through histology and microbiology of repeated endometrial samples. Overall participation lasts up to several years, with the primary results expected by the end of 2027 and further comparisons by early 2028.

CONDITIONS

Brief Title

Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

Who Can Participate

Age: 20Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 to 45 years
  • Women with 2 or more consecutive miscarriages before 24 weeks of gestation
  • Women who have not conceived after one year of unprotected intercourse
  • Women who failed to achieve clinical pregnancy after two consecutive IVF, ICSI, or frozen embryo replacement cycles with good-quality embryos
Not Eligible

You will not qualify if you...

  • Uncorrected uterine anomalies such as septate or bicornuate uterus, or fibroids (submucous/intramural)
  • Untreated hydrosalpinx
  • History of antiphospholipid syndrome
  • Known clinical autoimmune disease
  • Currently undergoing immunotherapy
  • Abnormal thyroid function
  • Abnormal karyotyping
  • Active pelvic inflammatory disease or suspected infection

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 menstrual cycle

Participants undergo endometrial sampling (ES) during the mid-luteal phase. In natural cycles, ES is obtained 7 days after the LH surge. In artificial cycles, participants receive estradiol and progesterone treatment before ES is obtained using a Pipelle sampler as an outpatient procedure.

1 to 2 visits depending on cycle type

Monitoring

Duration - Variable based on treatment response

If chronic endometritis (CE) is diagnosed, participants receive antibiotics as per hospital guidelines, followed by repeat endometrial sampling to reassess histology and microbiology.

1 follow-up visit for re-evaluation

Trial Site Locations

Total: 1 location

1

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

S

Stacey Wong, BSc

J

JacquelinePui Wah Chung, MBBS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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