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Trial record 1 of 1 for:    NCT02669628
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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
Sponsor:
Collaborator:
Roche Diagnostic Ltd.
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 evaluate the ovarian reserve after alcohol sclerotherapy of endometriomas versus conventional surgery.

Condition or disease Intervention/treatment
Endometriomas Procedure: Surgical technique Procedure: Alcohol sclerotherapy

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 Design
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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Ethanol

Groups and Cohorts
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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


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


Secondary Outcome Measures :
  1. antral follicles count [ Time Frame: 6 months ]
    US antral follicles count after both procedures

  2. tumoral markers: epididimal human protein 4 (HE-4) and CA125 [ Time Frame: 6 months ]
    the value tumoral markers after both procedures

  3. complications [ Time Frame: 1 day ]
    number of participants with complications

  4. costs [ Time Frame: 1 day ]
    costs (euros) of the procedures and their complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ultrasound suspicion of ovarian endometrioma (4-10 cm)
Criteria

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
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): NCT02669628


Locations
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Spain
Hospital Universitario Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08908
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Roche Diagnostic Ltd.
Investigators
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Principal Investigator: Amparo Garcia-Tejedor, MDPhD Hospital de Bellvitge. IDIBELL
More Information
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Publications:

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Responsible Party: Amparo Garcia-Tejedor, Dr, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT02669628    
Other Study ID Numbers: PR314/15
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The individual participant data should be available 6 months after the procedure
Additional relevant MeSH terms:
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Endometriosis