NCT06864494

Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay

L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years – 57 Years
• Healthy volunteers: —

Summary

Prostaglandin D2 (PGD2) has anti-inflammatory activity, particularly via Lipocalin type-prostaglandin (L-PGDS). L-PGDS has been studied in pathologies such as sleep apnea, rheumatoid arthritis, asthma and allergic phenomena, but never in adenomyosis. Adenomyosis is a estrogen-dependent multifactorial pathology whose pathophysiology is still poorly defined. This hyperestrogenism causes chronic inflammation, particularly via the activation of the prostaglandin H2 (PGH2) signaling pathway. This would lead to the excess production of prostaglandins E2 (PGE2) and F2a (PGF2a) and the decrease of PGD2 and therefore of L-PGDS, leading to the proliferation of endometrial cells in the myometrium by the epithelial-mesenchymal transition via aromatase. A preliminary study comparing the expression of L-PGDS found a significant decrease in L-PGDS in the uterus of women with adenomyosis lesions versus healthy controls. However, during this study, some information was not collected, including the patients' symptoms, preoperative radiological data and surgical indication. The study authors hypothesize that L-PGDS could be a potential tissue and circulating diagnostic marker of adenomyosis in its early stages. L-PGDS appears to be a good candidate to aid in the diagnosis of adenomyosis via a minimally invasive assay for patients (blood or urine).

Conditions

• Adenomyosis
• Endometriosis

Interventions

Type	Name	Description
PROCEDURE	Endometrial ablation	Performed using a transfer catheter (used for embryo transfers) positioned at the level of the internal cervical orifice in the uterine cavity. Five ml of saline will be injected and collected in a dry tube

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-03-07
• Last updated: 2026-03-18

Locations

1 site across 1 country: France