Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the role of a substance in the blood and urine called Lipocalin type-prostaglandin (L-PGDS) and its potential use as a marker for diagnosing adenomyosis, a condition where tissue similar to the lining of the uterus grows into the uterine wall, causing pain and other symptoms. Researchers believe that measuring L-PGDS could help identify adenomyosis in its early stages, which is important because this condition can cause chronic inflammation and discomfort. The study will involve women aged 40 to 55 who have been diagnosed with adenomyosis or have other related conditions, as well as women without any uterine problems who are seeking fertility assistance.

To participate in this trial, women must be non-menopausal, have had children, and be scheduled for a specific type of surgery called a total hysterectomy. They will be required to provide their consent and may undergo blood or urine tests to measure L-PGDS levels. Participants can expect to contribute to important research that may improve the understanding and diagnosis of adenomyosis. It’s important to note that some individuals, such as those with certain medical histories or conditions, will not be eligible to participate.

Gender

FEMALE

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.