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

Not Applicable

Terminated

• Conditions: Endometrioma; Fertility Disorders
• Interventions: Procedure: Sclerotherapy; Procedure: Surgery

• Registration Number: NCT03571776
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-31
• Study Start: 2018-06-05
• Study First Submitted QC: 2018-06-17
• Study First Posted: 2018-06-28
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sclerotherapy	Sclerotherapy	US-aspiration and alcohol sclerosis
Surgery	Surgery	Laparoscopic ovarian cystectomy

Primary Outcome Measures

Name	Time	Method
Change from Baseline AMH Test	prior and 6 months after both procedures	the value of AMH in ng/mL

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain