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

Catalan Institute of Health

Status: Terminated

Conditions: Fertility Disorders; Endometrioma

Treatments: Procedure: Surgery; Procedure: Sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03571776

PR031/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Surgery

Active Comparator group

Description:

Laparoscopic ovarian cystectomy

Treatment:

Procedure: Surgery

Sclerotherapy

Active Comparator group

Description:

US-aspiration and alcohol sclerosis

Treatment:

Procedure: Sclerotherapy