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NCT Number: NCT06864494

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

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).

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Key information

Conditions

Adenomyosis Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

18 year–57 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Nimes

Nîmes, 30029, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Pascal PHILIBERT

PRINCIPAL_INVESTIGATOR

Stéphanie HUBERLANT

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Endometrial ablation

Procedure

Performed using a transfer catheter (used for embryo transfers) positioned at the level of the internal cervical orifice in the uterine cavity. Five ml of saline will be injected and collected in a dry tube

Primary outcomes

  1. Concentration of L-PGDS in vaginal swabs between groups

    Time frame: Day 0

    Assessed with immunoenzymatic ELISA (µg/ml)

  2. Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups

    Time frame: Day 0

    Assessed with immunoenzymatic ELISA (µg/ml) Day 0

Secondary outcomes

  1. Concentration of L-PGDS in blood between groups

    Time frame: Day 0

    Assessed with immunoenzymatic ELISA (µg/ml) Day 0

  2. Concentration of L-PGDS in blood between groups

    Time frame: 7 weeks (range 6 to 8 weeks)

    Assessed with immunoenzymatic ELISA (µg/ml) Day 0

  3. Concentration of L-PGDS in urine between groups

    Time frame: Day 0

    Assessed with immunoenzymatic ELISA (µg/ml) Day 0

  4. Concentration of L-PGDS in urine between groups

    Time frame: 7 weeks (range 6 to 8 weeks)

    Assessed with immunoenzymatic ELISA (µg/ml) Day 0

  5. Adenomyosis severity grade

    Time frame: Day 0

    Measured by MRI. Severity grade: minimal (<25%), moderate (25-50%) or severe (>50%) uterine involvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphanie HUBERLANT

CONTACT

[email protected]

04.66.68.32.20

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups.

Acronym: ADENO-L

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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