Anti-mullerian Hormone (AMH) After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial

Study Overview
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Brief Summary
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The purpose of this multicenter study is to compare the ovarian reserve after alcohol sclerosis of the endometriomas against conventional surgery (AMH, follicle stimulating hormone (FSH) and antral follicles count) as well as the complications and costs between the 2 procedures.

Detailed Description
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Clinical Trial Phase III, Multicenter, National, open, parallel-group assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement. Patients with suspected ovarian endometrioma by ultrasound will be randomized into 2 groups: (a) Study Group: echoguided aspiration plus sclerosis with alcohol; (B) Control group: Laparoscopic Cystectomy. Pre-treatment, and 6 months after treatment, AMH values will be determined. Complications, recurrences and costs from each treatment will be collected.

Official Title
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Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial

Conditions
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Endometrioma, Fertility Disorders

Intervention / Treatment
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* Procedure: Surgery
* Procedure: Sclerotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uni- or bilocular endometrioma according ultrasounds Endometrioma size: 30-100 mm when symptoms were present and 50-100 mm if asymptomatics > 3 months from diagnosis Ca125 <200 IU/mL and human epididymis protein 4 (HE4) < 70, Exclusion Criteria: Previous gynecological cancer Symptomatic severe extraovarian endometriosis Dermoid or high risk of malignancy cysts Pregnancy Mental disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, National, assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery<br>Laparoscopic ovarian cystectomy | Procedure: Surgery<br>* Laparoscopic ovarian cystectomy<br>|
| Active Comparator: Sclerotherapy<br>US-aspiration and alcohol sclerosis | Procedure: Sclerotherapy<br>* US-aspiration and alcohol sclerosis<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline antral follicles count | US antral follicles count | prior and 6 months after both procedures | 
| Complications | number of participants with complications | 1 month after the procedure | 
| Costs | costs (euros) of the procedure plus cost of their complications | 1 month after the procedure | 
| Change from Baseline Pain | Visual Analog Score for pain (ranged 1-10). Patients pain evaluation fron 1 no pain to 10 maximum pain considered | prior and 6 months after both procedures |