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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06864494
Acronym
ADENO-L
Enrollment
60
Registered
2025-03-07
Start date
2025-06-25
Completion date
2027-06-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis, Endometriosis

Keywords

lipocalin-Type Prostaglandin D2 Synthase

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).

Interventions

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 57 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
Concentration of L-PGDS in vaginal swabs between groupsDay 0Assessed with immunoenzymatic ELISA (µg/ml)
Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groupsDay 0Assessed with immunoenzymatic ELISA (µg/ml) Day 0

Secondary

MeasureTime frameDescription
Concentration of L-PGDS in blood between groupsDay 0Assessed with immunoenzymatic ELISA (µg/ml) Day 0
Concentration of L-PGDS in urine between groupsDay 0Assessed with immunoenzymatic ELISA (µg/ml) Day 0
Adenomyosis severity gradeDay 0Measured by MRI. Severity grade: minimal (\<25%), moderate (25-50%) or severe (\>50%) uterine involvement.

Countries

France

Contacts

CONTACTStéphanie HUBERLANT
stephanie.huberlant@chu-nimes.fr04.66.68.32.20
PRINCIPAL_INVESTIGATORStéphanie HUBERLANT

Centre Hospitalier Universitaire de Nīmes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026