Anti-mullerian Hormone (AMH) After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial

February 28, 2023 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: Clinical Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital de 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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgery
Laparoscopic ovarian cystectomy
Procedure: Surgery
Laparoscopic ovarian cystectomy
Active Comparator: Sclerotherapy
US-aspiration and alcohol sclerosis
Procedure: Sclerotherapy
US-aspiration and alcohol sclerosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline antral follicles count
Time Frame: prior and 6 months after both procedures
US antral follicles count
prior and 6 months after both procedures
Complications
Time Frame: 1 month after the procedure
number of participants with complications
1 month after the procedure
Costs
Time Frame: 1 month after the procedure
costs (euros) of the procedure plus cost of their complications
1 month after the procedure
Change from Baseline Pain
Time Frame: 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
prior and 6 months after both procedures

Collaborators and Investigators

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

Sponsor

Hospital Universitari de Bellvitge

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 (Actual)

June 5, 2018

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

June 17, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR031/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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