AdenomyosisADENO-LNCT06864494
Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay
An observational study of Adenomyosis and Endometriosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 57 years, women only
- Conditions the study is for
- Adenomyosis, Endometriosis
- What is being tested?
- Endometrial ablation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 57 years
- Women only
- Adult
Study population: Multiparous, non-menopausal patients aged between 40 and 55 consulting the gynecology-obstetrics department of the CHU de Nîmes for menometrorrhagia and/or pelvic pain and having an indication for total inter-ovarian hysterectomy plus healthy controls aged between 18 and 43, nulliparous, without uterine pathologies treated at the Nîmes University Hospital's assisted reproduction center for male or idiopathic infertility.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nimes
Nîmes, 30029
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Stéphanie HUBERLANT
About this study
Official title: L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups.
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).
- Conditions
- Adenomyosis, Endometriosis
- Being tested
- Endometrial ablation
- Keywords
- lipocalin-Type Prostaglandin D2 Synthase
- Medical subject headings
- Adenomyosis, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial ablationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with adenomyosis (Adenomyosis +) | Not described Receives: Procedure: Endometrial ablation | |
| Patients with an endometrial pathology other than adenomyosis (Adenomyosis -) | Not described Receives: Procedure: Endometrial ablation | |
| Patients without uterine pathology (control) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of L-PGDS in vaginal swabs between groups
Assessed with immunoenzymatic ELISA (µg/ml)
Measured: Day 0
Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups
Assessed with immunoenzymatic ELISA (µg/ml) Day 0
Measured: Day 0
Secondary outcomes (5)
Concentration of L-PGDS in blood between groups
Assessed with immunoenzymatic ELISA (µg/ml) Day 0
Measured: Day 0
Concentration of L-PGDS in blood between groups
Assessed with immunoenzymatic ELISA (µg/ml) Day 0
Measured: 7 weeks (range 6 to 8 weeks)
Concentration of L-PGDS in urine between groups
Assessed with immunoenzymatic ELISA (µg/ml) Day 0
Measured: Day 0
Concentration of L-PGDS in urine between groups
Assessed with immunoenzymatic ELISA (µg/ml) Day 0
Measured: 7 weeks (range 6 to 8 weeks)
Adenomyosis severity grade
Measured by MRI. Severity grade: minimal (<25%), moderate (25-50%) or severe (>50%) uterine involvement.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start25 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie HUBERLANT, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864494
- Sponsor's protocol ID
- NIMAO/2024-1/SH01
- Acronym
- ADENO-L
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups.
- ClinicalTrials.gov ID
- NCT06864494
- Acronym / sponsor ID
- ADENO-L / NIMAO/2024-1/SH01
- Conditions
- Adenomyosis, Endometriosis
- Keywords
- lipocalin-Type Prostaglandin D2 Synthase
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with adenomyosis (Adenomyosis +) | – | Procedure: Endometrial ablation |
| Patients with an endometrial pathology other than adenomyosis (Adenomyosis -) | – | Procedure: Endometrial ablation |
| Patients without uterine pathology (control) | – | – |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Multiparous, non-menopausal patients aged between 40 and 55 consulting the gynecology-obstetrics department of the CHU de Nîmes for menometrorrhagia and/or pelvic pain and having an indication for total inter-ovarian hysterectomy plus healthy controls aged between 18 and 43, nulliparous, without uterine pathologies treated at the Nîmes University Hospital's assisted reproduction center for male or idiopathic infertility.
Key inclusion criteria (22 listed)
- 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
- Female.
- Aged 28 (≥) to 57 (≤) years.
- Non-menopausal.
Key exclusion criteria (13 listed)
- History of autoinflammatory or autoimmune disease.
- History of atopic or asthmatic conditions.
- History of sleep apnea syndrome.
- Chronic or acute renal failure.
- Liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial ablationPerformed 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 | Procedure or surgery | Patients with adenomyosis (Adenomyosis +), Patients with an endometrial pathology other than adenomyosis (Adenomyosis -) |
Primary outcome
Concentration of L-PGDS in vaginal swabs between groups
Time frame: Day 0
Assessed with immunoenzymatic ELISA (µg/ml)
Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups
Time frame: Day 0
Assessed with immunoenzymatic ELISA (µg/ml) Day 0
5 secondary outcomes
Concentration of L-PGDS in blood between groups
Time frame: Day 0
Concentration of L-PGDS in blood between groups
Time frame: 7 weeks (range 6 to 8 weeks)
Concentration of L-PGDS in urine between groups
Time frame: Day 0
Concentration of L-PGDS in urine between groups
Time frame: 7 weeks (range 6 to 8 weeks)
Adenomyosis severity grade
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie HUBERLANT principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis and Endometriosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie HUBERLANT (04.66.68.32.20, stephanie.huberlant@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of L-PGDS in vaginal swabs between groups (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.