Hysteroscopy and CD138+ Plasma Cell Density in Chronic Endometritis

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Conditions studied: Chronic Endometritis

In brief

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

Key facts

Study ID

NCT07733713

Run by

Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)

People needed

100

Starts

2026-09-14

Expected to finish

2026-11-26

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 46. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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