Actively Recruiting

Age: 18Years - 57Years
FEMALE
ID06864494

L-PGDS Quantification in Genital, Blood, and Urine Samples From Adenomyosis Patients Compared to Two Control Groups

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-03-18

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adenomyosis, a condition linked to excess estrogen causing chronic inflammation that leads to the growth of endometrial cells in the uterus muscle. This research focuses on Lipocalin type-prostaglandin D synthase (L-PGDS), a protein that may help diagnose adenomyosis early through blood or urine tests. The study compares L-PGDS levels in women with adenomyosis, women with other uterine pathologies, and healthy controls to better understand its role and potential as a diagnostic marker. Participants are grouped into those with adenomyosis, those with other uterine conditions, and healthy controls. The study collects samples including vaginal swabs, blood, urine, and tissue from endometrial ablation during surgery. The procedure involves injecting saline into the uterus to collect samples. The study measures L-PGDS concentrations in these samples on the day of collection and again in blood and urine after 6 to 8 weeks. During the study, participants will undergo endovaginal ultrasound or hysterectomy as clinically indicated. Researchers assess L-PGDS levels in various samples and grade adenomyosis severity. The study monitors participants for up to seven weeks and records clinical and imaging data. This observational study lasts from initial sample collection to follow-up evaluations, aiming to improve adenomyosis diagnosis using minimally invasive methods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 57Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients
  • Aged 18 to 57 years
  • Must have given free and informed consent and signed the consent form
  • Must be a member or beneficiary of a health insurance plan
  • For adenomyosis and adenomyosis-negative groups: aged 28 to 57 years, non-menopausal, and scheduled for total inter-ovarian hysterectomy (excluding oncology)
  • For adenomyosis group: diagnosed with adenomyosis
  • For adenomyosis-negative group: diagnosed with a functional uterine pathology other than adenomyosis
  • For control group: asymptomatic with no uterine pathology on endovaginal ultrasound, undergoing assisted reproduction management
Not Eligible

You will not qualify if you...

  • 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 cancer or neoplasia
  • Use of NSAIDs, corticosteroids, or aspirin within 15 days before L-PGDS measurement
  • Current use of estrogen-progestin hormonal contraception
  • Contraindication to MRI for adenomyosis groups
  • Refusal of endovaginal ultrasound for control group
  • Presence of functional ovarian cyst on imaging for control group

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo sample collection including vaginal swabs, blood, urine, and endometrial ablation where applicable.

1 visit (in-person)

Long-term Monitoring

Duration - 7 weeks (range 6 to 8 weeks)

Participants provide follow-up blood and urine samples to monitor L-PGDS concentrations over time.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

CHU de Nimes

Nîmes, France, 30029

Actively Recruiting

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Research Team

S

Stéphanie HUBERLANT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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