Measuring L-PGDS levels in blood, urine, vaginal fluid and endometrial tissue
L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups.
This project will test whether L-PGDS levels in blood, urine, vaginal fluid and uterine tissue differ between women with adenomyosis, other benign uterine conditions, and healthy controls.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 57 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT06864494 on ClinicalTrials.gov |
What this trial studies
This observational study will collect blood, urine, vaginal samples and endometrial tissue from women with adenomyosis, women with other benign functional uterine pathologies undergoing hysterectomy, and asymptomatic control women attending fertility care at CHU de Nîmes. L-PGDS concentrations will be measured by enzyme-linked immunosorbent assay (ELISA) in all sample types and compared across the groups. The study tests the hypothesis that decreased L-PGDS reflects a prostaglandin imbalance that contributes to inflammation and endometrial cell proliferation in adenomyosis. Clinical data and sample timing will be recorded to correlate L-PGDS levels with symptoms and pathological findings.
Who should consider this trial
Good fit: Ideal participants are non-menopausal women aged 28–57 scheduled for hysterectomy for adenomyosis or other benign uterine conditions, and asymptomatic women aged 18–57 attending the CHU de Nîmes fertility clinic as controls.
Not a fit: Postmenopausal women, patients undergoing surgery for cancer, women outside the specified age ranges, or those unable to attend CHU de Nîmes are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, it could identify L-PGDS as a biomarker to improve diagnosis or understanding of adenomyosis and guide new treatment approaches.
How similar studies have performed: A small preliminary tissue study reported decreased uterine L-PGDS in adenomyosis, but measurement across blood and non-invasive samples is novel and not yet validated.
Eligibility criteria
Show full inclusion / exclusion 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 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).
Where this trial is running
Nîmes
- CHU de Nimes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Stéphanie HUBERLANT — Centre Hospitalier Universitaire de Nīmes
- Study coordinator: Stéphanie HUBERLANT
- Email: stephanie.huberlant@chu-nimes.fr
- Phone: 04.66.68.32.20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.