Investigating chronic endometritis in women with reproductive failure
Confounding Factors of Chronic Endometritis in Women With Reproductive Failure
This study is trying to see if treating chronic endometritis with specific antibodies can help women who are having trouble getting pregnant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05613049 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the confounding factors associated with chronic endometritis and the potential therapeutic benefits of antibodies targeting plasma cells in women experiencing reproductive failure. Eligible participants will be recruited from the IVF and miscarriage clinic at the Prince of Wales Hospital/CUHK medical centre. The study will involve endometrial sampling during the mid-luteal phase, with hormonal assessments and ultrasound evaluations to ensure proper timing and conditions for sampling. Immunohistochemical techniques will be employed to quantify plasma cells in the endometrial tissue, which may provide insights into the role of chronic endometritis in infertility.
Who should consider this trial
Good fit: Ideal candidates include women aged 20-45 with a history of recurrent miscarriages or those who have failed to conceive after multiple IVF attempts.
Not a fit: Patients with uncorrected uterine anomalies, untreated hydrosalpinx, or known autoimmune diseases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for women facing infertility due to chronic endometritis.
How similar studies have performed: While similar studies have explored aspects of chronic endometritis, this specific approach focusing on plasma cells and their therapeutic implications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Jacqueline Pui Wah Chung, MBBS — Chinese University of Hong Kong
- Study coordinator: Stacey Wong, BSc
- Email: staceywong@cuhk.edu.hk
- Phone: 35051764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.