Antimullerian Hormone in Endometriomas

Study Overview
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Brief Summary
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The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol sclerotherapy of endometriomas versus conventional surgery.

Detailed Description
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Between 5-10% fertile women are affected by endometriosis, and ovarian endometrioma is present in 17-44% of cases, with 40% of patients with endometriomas being sterile. However, the gold standard treatment is laparoscopic ovarian cystectomy and this therapy is associated with a diminished ovarian reserve, with a significant antimullerian hormone (AMH) decrease. Alcohol sclerotherapy is a new minimal invasive procedure in endometrioma treatment whose potential beneficial effect in fertility preservation is not still demonstrated. The investigators would like to demonstrate that this procedure improves fertility preservation and reduces morbidity and costs in contrast with conventional surgery. Moreover,the investigators would like to demonstrate that this procedure could be performed in different centers with similar results.

Official Title
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Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery. A Pilot Study.

Conditions
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Endometriomas

Intervention / Treatment
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* Procedure: Surgical technique
* Procedure: Alcohol sclerotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Age ≥18 and <40 years Unilocular endometrioma according ultrasounds Endometrioma size: 35-100 mm during > 3 months from diagnosis CA125 <200 IU/mL and HE4 < 70, AMH previous surgery between 1.2-4 ng/mL Exclusion Criteria: Previous ovarian surgery or gynecological cancer Severe extraovarian endometriosis Dermoid or high risk of malignancy cysts Hormonal treatment 3 months before Pregnancy Mental disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical technique<br>Laparoscopic ovarian cystectomy | Procedure: Surgical technique<br>* Laparoscopic surgery<br>|
| Alcohol sclerotherapy<br>US-aspiration and alcohol sclerosis | Procedure: Alcohol sclerotherapy<br>* US-guided sclerotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMH Test | the value of AMH after both procedures in ng/mL | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antral follicles count | US antral follicles count after both procedures | 6 months | 
| tumoral markers: epididimal human protein 4 (HE-4) and CA125 | the value tumoral markers after both procedures | 6 months | 
| complications | number of participants with complications | 1 day | 
| costs | costs (euros) of the procedures and their complications | 1 day |