Hysteroscopy and CD138+ Plasma Cell Density in Chronic Endometritis | NCT07733713

NCT07733713

Overview

NCT ID: NCT07733713
Lead Sponsor: Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)OTHER
Official Title: Correlation Between Hysteroscopic Signs of Chronic Endometritis and CD138-Positive Endometrial Plasma Cell Density in Women Undergoing Outpatient Hysteroscopy: a Prospective, Single-Centre Observational Study
Brief 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

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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