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

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ClinicalTrials.gov Identifier: NCT03571776
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge

Study Description
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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.

Condition or disease Intervention/treatment Phase
Endometrioma Fertility Disorders Procedure: Surgery Procedure: Sclerotherapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, National, assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline AMH Test [ Time Frame: prior and 6 months after both procedures ]
    the value of AMH in ng/mL


Secondary Outcome Measures :
  1. Change from Baseline antral follicles count [ Time Frame: prior and 6 months after both procedures ]
    US antral follicles count

  2. Complications [ Time Frame: 1 month after the procedure ]
    number of participants with complications

  3. Costs [ Time Frame: 1 month after the procedure ]
    costs (euros) of the procedure plus cost of their complications

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03571776


Contacts
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Contact: Amparo Garcia-Tejedor, MDPhD 0034-660.22.34.17 agarciat@bellvitgehospital.cat
Contact: Jordi Ponce, MDPhD jponce@bellvitgehospital.cat

Locations
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Spain
Hospital de Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Amparo Garcia-Tejedor, MDPhD    0034-660223417    agarciat@bellvitgehospital.cat   
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
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Principal Investigator: Amparo Garcia-Tejedor, MDPhD Hospital de Bellvitge. IDIBELL
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Amparo Garcia-Tejedor, Principal Investigator, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03571776    
Other Study ID Numbers: PR031/18
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis