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

NCT06864494 | Recruiting

• 1 other identifier: NIMAO/2024-1/SH01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Endometriosis; Adenomyosis

Keywords

lipocalin-Type Prostaglandin D2 Synthase

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Concentration of L-PGDS in blood between groups

  Day 0

• Concentration of L-PGDS in blood between groups

  7 weeks (range 6 to 8 weeks)

• Concentration of L-PGDS in urine between groups

  Day 0

• Concentration of L-PGDS in urine between groups

  7 weeks (range 6 to 8 weeks)

• Adenomyosis severity grade

  Day 0

Study Arms (3)

Patients with adenomyosis (Adenomyosis +)

Procedure: Endometrial ablation

Patients with an endometrial pathology other than adenomyosis (Adenomyosis -)

Procedure: Endometrial ablation

Patients without uterine pathology (control)

Interventions

Endometrial ablation PROCEDURE

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 adenomyosis (Adenomyosis +); Patients with an endometrial pathology other than adenomyosis (Adenomyosis -)

Eligibility Criteria

• Age: 18 Years - 57 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal swabs, endometrial ablation samples, urine, blood

MeSH Terms

Conditions

Adenomyosis; Endometriosis

Interventions

Endometrial Ablation Techniques

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Stéphanie HUBERLANT

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie HUBERLANT

CONTACT

04.66.68.32.20; stephanie.huberlant@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (1)