Antimullerian Hormone in Endometriomas

February 21, 2018 updated by: Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge

Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery. A Pilot Study.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Universitario Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with ultrasound suspicion of ovarian endometrioma (4-10 cm)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical technique
Laparoscopic ovarian cystectomy
Procedure: Surgical technique
Laparoscopic surgery
Alcohol sclerotherapy
US-aspiration and alcohol sclerosis
Procedure: Alcohol sclerotherapy
US-guided sclerotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH Test
Time Frame: 6 months
the value of AMH after both procedures in ng/mL
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antral follicles count
Time Frame: 6 months
US antral follicles count after both procedures
6 months
tumoral markers: epididimal human protein 4 (HE-4) and CA125
Time Frame: 6 months
the value tumoral markers after both procedures
6 months
complications
Time Frame: 1 day
number of participants with complications
1 day
costs
Time Frame: 1 day
costs (euros) of the procedures and their complications
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Collaborators

Roche Diagnostic Ltd.

Investigators

  • Principal Investigator: Amparo Garcia-Tejedor, MDPhD, Hospital de Bellvitge. IDIBELL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 23, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR314/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data should be available 6 months after the procedure

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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