Antimullerian Hormone in Endometriomas

Catalan Institute of Health

Status: Completed

Conditions: Endometriomas

Treatments: Procedure: Surgical technique; Procedure: Alcohol sclerotherapy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02669628

PR314/15

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 2 patient groups

Surgical technique

Description:

Laparoscopic ovarian cystectomy

Treatment:

Procedure: Surgical technique

Alcohol sclerotherapy

Description:

US-aspiration and alcohol sclerosis

Treatment:

Procedure: Alcohol sclerotherapy