Endometriomas
Conditions
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.
Interventions
PROCEDURESurgical technique
Laparoscopic surgery
PROCEDUREAlcohol sclerotherapy
US-guided sclerotherapy
Sponsors
Roche Diagnostic Ltd.
Hospital Universitari de Bellvitge
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AMH Test | 6 months | the value of AMH after both procedures in ng/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| complications | 1 day | number of participants with complications |
| costs | 1 day | costs (euros) of the procedures and their complications |
Countries
Spain
Outcome results
None listed