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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Adenomyosis
• Intervention / Treatment: Procedure: Endometrial ablation

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Stéphanie HUBERLANT; Phone Number: 04.66.68.32.20; Email: stephanie.huberlant@chu-nimes.fr

Study Locations

• France
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nîmes
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Stéphanie HUBERLANT
    • Principal Investigator: Pascal PHILIBERT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Multiparous, non-menopausal patients aged between 40 and 55 consulting the gynecology-obstetrics department of the CHU de Nîmes for menometrorrhagia and/or pelvic pain and having an indication for total inter-ovarian hysterectomy plus healthy controls aged between 18 and 43, nulliparous, without uterine pathologies treated at the Nîmes University Hospital's assisted reproduction center for male or idiopathic infertility.

Description

Inclusion Criteria:

Common inclusion criteria:

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan

Adenomyosis + group:

• Female.
• Aged 28 (≥) to 57 (≤) years.
• Non-menopausal.
• Having an indication for a total inter-ovarian hysterectomy (excluding oncology).
• Suffering from adenomyosis.

Adenomyosis - group:

• Female.
• Aged 28 (≥) to 57 (≤) years.
• Non-menopausal.
• Having an indication for a total inter-ovarian hysterectomy (excluding oncology).
• Suffering from a functional pathology other than adenomyosis.

Control Group:

• Female.
• Aged 18 (≥) to 57 (≤) years.
• Asymptomatic: absence of menometrorrhagia and pelvic pain.
• Support at the medically assisted procreation (MAP) center of the Nîmes University Hospital for male or idiopathic infertility.
• Indication to perform an endovaginal ultrasound as part of MAP management.
• Absence of uterine pathology visualized on endovaginal ultrasound.

Exclusion Criteria:

• History of autoinflammatory or autoimmune disease.
• History of atopic or asthmatic conditions.
• History of sleep apnea syndrome.
• Chronic or acute renal failure.
• Liver failure
• History of active neoplasia or cancer.
• Taking nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or aspirin in the 15 days prior to L-PGDS concentration measurement
• Undergoing estrogen-progestin hormonal contraception.

Adenomyosis groups:

- Contraindication to MRI.

Control Group:

• Endovaginal ultrasound refused by the patient.
• Presence of a functional-looking ovarian cyst on imaging (endovaginal ultrasound and/or pelvic MRI).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with adenomyosis (Adenomyosis +)	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
Patients with an endometrial pathology other than adenomyosis (Adenomyosis -)	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
Patients without uterine pathology (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of L-PGDS in vaginal swabs between groups	Assessed with immunoenzymatic ELISA (µg/ml)	Day 0
Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups	Assessed with immunoenzymatic ELISA (µg/ml) Day 0	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of L-PGDS in blood between groups	Assessed with immunoenzymatic ELISA (µg/ml) Day 0	Day 0
Concentration of L-PGDS in blood between groups	Assessed with immunoenzymatic ELISA (µg/ml) Day 0	7 weeks (range 6 to 8 weeks)
Concentration of L-PGDS in urine between groups	Assessed with immunoenzymatic ELISA (µg/ml) Day 0	Day 0
Concentration of L-PGDS in urine between groups	Assessed with immunoenzymatic ELISA (µg/ml) Day 0	7 weeks (range 6 to 8 weeks)
Adenomyosis severity grade	Measured by MRI. Severity grade: minimal (<25%), moderate (25-50%) or severe (>50%) uterine involvement.	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Stéphanie HUBERLANT, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: lipocalin-Type Prostaglandin D2 Synthase
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Adenomyosis; Endometriosis; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Ablation Techniques; Endometrial Ablation Techniques
• Other Study ID Numbers: NIMAO/2024-1/SH01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No