Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 158
- Locations
- 2
- Primary Endpoint
- Change from Baseline AMH Test
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from Baseline AMH Test
Time Frame: prior and 6 months after both procedures
the value of AMH in ng/mL
Secondary Outcomes
- Costs(1 month after the procedure)
- Change from Baseline antral follicles count(prior and 6 months after both procedures)
- Complications(1 month after the procedure)
- Change from Baseline Pain(prior and 6 months after both procedures)
Investigators
Amparo Garcia-Tejedor
Principal Investigator
Hospital Universitari de Bellvitge