Antimullerian Hormone in Endometriomas

Completed

• Conditions: Endometriomas
• Interventions: Procedure: Surgical technique; Procedure: Alcohol sclerotherapy

• Registration Number: NCT02669628
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-01-23
• Study First Submitted QC: 2016-01-27
• Study Start: 2016-02
• Study First Posted: 2016-02-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical technique	Surgical technique	Laparoscopic ovarian cystectomy
Alcohol sclerotherapy	Alcohol sclerotherapy	US-aspiration and alcohol sclerosis

Primary Outcome Measures

Name	Time	Method
AMH Test	6 months	the value of AMH after both procedures in ng/mL

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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