Endometriosis OvaryENDOPAL AMHNCT04461899
Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
A study testing Blood test in people with Endometriosis Ovary, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep pelvic endometriosis (subperitoneal). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Endometriosis Ovary
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Jul 2020to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient in childbearing age from 18 to 42 years.
- Patient with uni- or bilateral endometrioma(s) without clinical and ultrasound criteria for ovarian carcinoma.
- A sclerotherapy is programmed.
- Patient affiliated to a social security scheme.
- Patient who gave consent for this research.
Who cannot join
- doubt about the endometriotic origin of the cyst
- suspect malignant ovarian disease.
- Pregnant or breastfeeding patient.
- Patient participating in other research with an exclusion period still in progress at the time of inclusion or those included in interventional research that interferes with the study protocol.
- Patient deprived of liberty by judicial or administrative decision.
- Patient (≥ 18 years old) under legal protection or unable to give consent.
- Patient does not speak French.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital Femme Mère Enfant
Bron
Hopital de la Croix Rousse
Lyon, 69004
Hopital Lyon Sud
Pierre-Bénite, 69495
About this study
Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep pelvic endometriosis (subperitoneal).
Surgical management of endometriomas is justified in cases of significant clinical symptoms (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is now well demonstrated that this surgery significantly reduces the ovarian reserve.
Read more
Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas. Several studies demonstrated the effectiveness and safety of this treatment, particularly in terms of preserving fertility. Regarding these reassuring data, many clinicians changed their practices and propose this technique as a first-line surgery.
Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.
The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy. This study is conducted in the Hospices Civils de Lyon, in 3 different sites.
- Conditions
- Endometriosis Ovary
- Being tested
- Blood test
- Keywords
- endometrioma, sclerotherapy, ovarian reserve, antimüllerian hormone
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.
| Study group | Role | What they receive |
|---|---|---|
| sclerotherapy | Other | a sclerotherapy will be done in patients Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH level
Measured: 3 months (+/-15 days) after endometrioma sclerotherapy
Secondary outcomes (4)
AMH level
Measured: 12 months (+/-15 days) after endometrioma sclerotherapy
AMH level
AMH level 3 and 12 months after endometrioma sclerotherapy
Measured: 12 months after endometrioma sclerotherapy
Endometrioma recurrence
New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple
Measured: 3 months (+/-15 days) after endometrioma sclerotherapy
Endometrioma recurrence
New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple
Measured: 12 months (+/-15 days) after endometrioma sclerotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start9 Jul 2020
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis OvaryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gil DUBERNARD, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461899
- Sponsor's protocol ID
- 69HCL20_0002
- Other IDs
- 2020-A00118-31
- Acronym
- ENDOPAL AMH
- Status last verified
- Sep 2023
- First submitted
- 29 Jun 2020
- Last updated
- 25 Sep 2023
- 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 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
- ClinicalTrials.gov ID
- NCT04461899
- Acronym / sponsor ID
- ENDOPAL AMH / 69HCL20_0002
- Conditions
- Endometriosis Ovary
- Keywords
- endometrioma, sclerotherapy, ovarian reserve, antimüllerian hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 8 Jul 2020 (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.
Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep pelvic endometriosis (subperitoneal).
Surgical management of endometriomas is justified in cases of significant clinical symptoms (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is now well demonstrated that this surgery significantly reduces the ovarian reserve.
Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas. Several studies demonstrated the effectiveness and safety of this treatment, particularly in terms of preserving fertility. Regarding these reassuring data, many clinicians changed their practices and propose this technique as a first-line surgery.
Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.
The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy. This study is conducted in the Hospices Civils de Lyon, in 3 different sites.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sclerotherapy | Other | Biological: Blood testa sclerotherapy will be done in patients |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient in childbearing age from 18 to 42 years.
- Patient with uni- or bilateral endometrioma(s) without clinical and ultrasound criteria for ovarian carcinoma.
- A sclerotherapy is programmed.
- Patient affiliated to a social security scheme.
- Patient who gave consent for this research.
Key exclusion criteria (7 listed)
- doubt about the endometriotic origin of the cyst
- suspect malignant ovarian disease.
- Pregnant or breastfeeding patient.
- Patient participating in other research with an exclusion period still in progress at the time of inclusion or those included in interventional research that interferes with the study protocol.
- Patient deprived of liberty by judicial or administrative decision.
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 |
|---|---|---|
| Blood testadditional blood test will be done 3 and 12 months after endometrioma sclerotherapy. | Biological | sclerotherapy |
Primary outcome
AMH level
Time frame: 3 months (+/-15 days) after endometrioma sclerotherapy
4 secondary outcomes
AMH level
Time frame: 12 months (+/-15 days) after endometrioma sclerotherapy
AMH level
Time frame: 12 months after endometrioma sclerotherapy
Endometrioma recurrence
Time frame: 3 months (+/-15 days) after endometrioma sclerotherapy
Endometrioma recurrence
Time frame: 12 months (+/-15 days) after endometrioma sclerotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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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. This study is not recruiting at the moment.
Gil DUBERNARD, Pr principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Endometriosis Ovary, run by Hospices Civils de Lyon at 3 sites 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH level (time frame: 3 months (+/-15 days) after endometrioma sclerotherapy). 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 25 Sep 2023.