Hysteroscopy and CD138+ Plasma Cell Density in Chronic Endometritis (NCT07733713) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Hysteroscopy and CD138+ Plasma Cell Density in Chronic Endometritis
100 participantsStarted 2026-09-14
Plain-language summary
The goal of this observational study is to learn if a hysteroscopy exam alone can find chronic endometritis, a long-lasting inflammation of the lining of the uterus. A hysteroscopy is an exam that looks inside the uterus with a thin camera. Chronic endometritis is usually confirmed with a lab test that counts CD138-positive cells, a type of immune cell, in a small tissue sample from the uterus.
About 100 women will take part. All are already having a hysteroscopy and a tissue sample as part of their fertility care, often after repeated failed embryo transfers or repeated miscarriage.
The main question it aims to answer is:
Do the visual signs seen during hysteroscopy relate closely enough to the CD138 cell count to reliably find chronic endometritis without a lab test?
Participants will:
Have a hysteroscopy exam and a tissue sample from the uterus, both already part of their routine fertility care Have their hysteroscopy video reviewed by two doctors who do not know the tissue sample results Have their tissue sample checked in the lab for CD138 cells
Who can participate
Age range
18 Years – 46 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Woman aged 18-46 years undergoing office hysteroscopy with endometrial biopsy as part of her clinical work-up (including assisted reproduction/PMA pathways), for any indication (recurrent implantation failure, recurrent pregnancy loss, or other).
* Examination performed during the early-to-mid proliferative phase (cycle days 6-12) of a spontaneous cycle not exposed to exogenous progestins
* Written informed consent to participation and to data processing
Exclusion Criteria:
* Current or suspected pregnancy
* Postmenopausal status
* Clinically active pelvic or lower genital tract infection
* Systemic antibiotic use within the preceding 4 weeks
* Use of exogenous progestins or other hormonal therapy within the preceding 4 weeks
* Submucous myoma, endometrial polyp, or synechiae precluding reliable
* assessment of the endometrial surface
* Inability to obtain adequate endometrial tissue for immunohistochemistry
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Spearman correlation between CD138-positive endometrial plasma cell count and number of positive hysteroscopic signs of chronic endometritis
Timeframe: Baseline - single time point; hysteroscopy and endometrial biopsy are performed in the same clinical session, so the interval between index test and reference standard is zero
Trial details
NCT IDNCT07733713
SponsorCentro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)