NCT06864494Recruiting
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.
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- 25 Jun 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Diseases
- Endometriosis
- NCT number
- NCT06864494
What you commit to
- Study type: Observational
- Planned participants: 60
- From 25 Jun 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or aspirin in the 15 days prior to L-PGDS concentration measurement
Other illness
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 57 years · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.