Antimullerian Hormone in Endometriomas
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|ClinicalTrials.gov Identifier: NCT02669628|
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment|
|Endometriomas||Procedure: Surgical technique Procedure: Alcohol sclerotherapy|
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.
|Study Type :||Observational|
|Actual Enrollment :||34 participants|
|Official Title:||Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery. A Pilot Study.|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Laparoscopic ovarian cystectomy
Procedure: Surgical technique
US-aspiration and alcohol sclerosis
Procedure: Alcohol sclerotherapy
- AMH Test [ Time Frame: 6 months ]the value of AMH after both procedures in ng/mL
- antral follicles count [ Time Frame: 6 months ]US antral follicles count after both procedures
- tumoral markers: epididimal human protein 4 (HE-4) and CA125 [ Time Frame: 6 months ]the value tumoral markers after both procedures
- complications [ Time Frame: 1 day ]number of participants with complications
- costs [ Time Frame: 1 day ]costs (euros) of the procedures and their complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669628
|Hospital Universitario Bellvitge|
|Hospitalet de Llobregat, Barcelona, Spain, 08908|
|Principal Investigator:||Amparo Garcia-Tejedor, MDPhD||Hospital de Bellvitge. IDIBELL|