Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endom… (NCT06864494) | Clinical Trial Compass
RecruitingNot Applicable
Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay
France60 participantsStarted 2025-06-25
Plain-language 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).
Who can participate
Age range
18 Years – 57 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of L-PGDS in vaginal swabs between groups
Timeframe: Day 0
2
Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups