Endometrioma, Fertility Disorders
Conditions
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.
Interventions
PROCEDURESurgery
Laparoscopic ovarian cystectomy
PROCEDURESclerotherapy
US-aspiration and alcohol sclerosis
Sponsors
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, National, assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline AMH Test | prior and 6 months after both procedures | the value of AMH in ng/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Costs | 1 month after the procedure | costs (euros) of the procedure plus cost of their 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 |
Countries
Spain
Outcome results
None listed