Clinical trial NCT06864494: Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay
Official title: L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Adenomyosis
Endometriosis
Keywords: lipocalin-Type Prostaglandin D2 Synthase
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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 40 (≥) to 55 (≤) years.
* Multiparous.
* Non-menopausal.
* Having an indication for a total inter-ovarian hysterectomy (excluding oncology).
* Suffering from adenomyosis.

Adenomyosis - group:

* Female.
* Aged 40 (≥) to 55 (≤) years.
* Multiparous.
* 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 43 (≤) years.
* Nulliparous.
* 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.
* Presence of a functional-looking ovarian cyst on imaging (endovaginal ultrasound and/or pelvic MRI).
* 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.

Primary outcomes:
measure: Concentration of L-PGDS in vaginal swabs between groups
timeFrame: Day 0
measure: Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups
timeFrame: Day 0
Secondary outcomes:
measure: Concentration of L-PGDS in blood between groups
timeFrame: Day 0
measure: Concentration of L-PGDS in blood between groups
timeFrame: 7 weeks (range 6 to 8 weeks)
measure: Concentration of L-PGDS in urine between groups
timeFrame: Day 0
measure: Concentration of L-PGDS in urine between groups
timeFrame: 7 weeks (range 6 to 8 weeks)
measure: Adenomyosis severity grade
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Stéphanie HUBERLANT
role: PRINCIPAL_INVESTIGATOR
References: