Hysteroscopy and CD138+ Plasma Cell Density in Chronic Endometritis

NCT07733713 | Not Yet Recruiting

• 1 other identifier: HYSTO-CD138
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Endometritis

Keywords

CD138; Endometrial Plasma Cells; Syndecan-1; Hysteroscopy; Diagnostic Accuracy; Recurrent Implantation Failure; Recurrent Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• Spearman correlation between CD138-positive endometrial plasma cell count and number of positive hysteroscopic signs of chronic endometritis

  Correlation (Spearman's rho) between the count of CD138-positive endometrial stromal plasma cells, quantified by immunohistochemistry as a continuous variable, and the number of positive hysteroscopic signs among the six Cicinelli criteria (range 0-6). The primary hypothesis is one of equivalence: the true correlation is hypothesized to fall within a pre-specified smallest effect size of interest (SESOI) of \|r\| \< 0.25. Equivalence is assessed using two one-sided tests (TOST) and complemented by a Bayes Factor quantifying the evidence in favor of the null hypothesis, together with the posterior probability that \|r\| is below the SESOI.

  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

Eligibility Criteria

• Age: 18 Years - 46 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18-46 years referred for office hysteroscopy with endometrial biopsy at Centro A.M.B.R.A. (Palermo, Italy), for any clinical indication including recurrent implantation failure, recurrent pregnancy loss, or other reasons. All examinations are performed during the early-to-mid proliferative phase (cycle days 6-12) of a spontaneous, non-progestin-exposed menstrual cycle. Approximately 100 participants will be prospectively enrolled and registered; an additional approximately 20 patients evaluated before study initiation constitute a separate pilot cohort and are not included in this population.

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

Sponsors & Collaborators

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07