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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00118-31 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sclerotherapy | Other | a sclerotherapy will be done in patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Biological | additional blood test will be done 3 and 12 months after endometrioma sclerotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AMH level | 3 months (+/-15 days) after endometrioma sclerotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| AMH level | 12 months (+/-15 days) after endometrioma sclerotherapy | |
| AMH level | AMH level 3 and 12 months after endometrioma sclerotherapy | 12 months after endometrioma sclerotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gil DUBERNARD, Pr | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Femme Mère Enfant | Bron | France | ||||
| Hopital de la Croix Rousse |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Endometrioma recurrence | New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple | 3 months (+/-15 days) after endometrioma sclerotherapy |
| Endometrioma recurrence | New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple | 12 months (+/-15 days) after endometrioma sclerotherapy |
| Lyon |
| 69004 |
| France |
| Hopital Lyon Sud | Pierre-Bénite | 69495 | France |
| D000091662 | Genital Diseases |