Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy (ENDOPAL AMH)
Primary Purpose
Endometriosis Ovary
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by

About this trial
This is an interventional basic science trial for Endometriosis Ovary focused on measuring endometrioma, sclerotherapy, ovarian reserve, antimüllerian hormone
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hopital Femme Mère Enfant
- Hopital de la Croix Rousse
- Hopital Lyon Sud
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
sclerotherapy
Arm Description
a sclerotherapy will be done in patients
Outcomes
Primary Outcome Measures
AMH level
Secondary Outcome Measures
AMH level
AMH level
AMH level 3 and 12 months after endometrioma sclerotherapy
Endometrioma recurrence
New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple
Endometrioma recurrence
New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple
Full Information
NCT ID
NCT04461899
First Posted
June 29, 2020
Last Updated
September 22, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT04461899
Brief Title
Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
Acronym
ENDOPAL AMH
Official Title
Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
April 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis Ovary
Keywords
endometrioma, sclerotherapy, ovarian reserve, antimüllerian hormone
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sclerotherapy
Arm Type
Other
Arm Description
a sclerotherapy will be done in patients
Intervention Type
Biological
Intervention Name(s)
Blood test
Intervention Description
additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.
Primary Outcome Measure Information:
Title
AMH level
Time Frame
3 months (+/-15 days) after endometrioma sclerotherapy
Secondary Outcome Measure Information:
Title
AMH level
Time Frame
12 months (+/-15 days) after endometrioma sclerotherapy
Title
AMH level
Description
AMH level 3 and 12 months after endometrioma sclerotherapy
Time Frame
12 months after endometrioma sclerotherapy
Title
Endometrioma recurrence
Description
New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple
Time Frame
3 months (+/-15 days) after endometrioma sclerotherapy
Title
Endometrioma recurrence
Description
New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple
Time Frame
12 months (+/-15 days) after endometrioma sclerotherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil DUBERNARD, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Femme Mère Enfant
City
Bron
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Learn more about this trial
Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
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