Measuring L-PGDS levels in blood, urine, vaginal fluid and endometrial tissue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.