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Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy

Primary Purpose

Endometriosis Ovary

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CO2 (carbon dioxide) laser vaporisation
Stripping technique
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis Ovary

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 45.
  • Bilateral endometriomas.
  • Endometrioma size > 3 cm.
  • Pain and/or infertility as indication to surgical treatment.

Exclusion Criteria:

  • History of cancer.
  • Suspected malignancy.
  • Evidence of premature ovarian failure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Stripping technique

    Laser technique

    Arm Description

    The endometrioma is removed according to standard surgery.

    The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser

    Outcomes

    Primary Outcome Measures

    Ovarian reserve
    Antral follicular count by ultrasound: number of antral follicles.
    Ovarian volume
    Ovarian volume will be assesses by ultrasound, units given with milliliters

    Secondary Outcome Measures

    Pregnancy rate
    Pregnancy rate will be recorded during the 6 months follow-up

    Full Information

    First Posted
    January 20, 2019
    Last Updated
    January 30, 2019
    Sponsor
    Hospital Clinic of Barcelona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03826355
    Brief Title
    Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
    Official Title
    Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Clinic of Barcelona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometriosis Ovary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    The ultrasonographer will be blinded to the procedure performed in each ovary after surgery. The patient will not be told which procedure has been performed in each ovary. The investigator will not know which procedure has been performed in each ovary until the end of the study. Only the surgeon will know which procedure is performed in each ovary.
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stripping technique
    Arm Type
    Active Comparator
    Arm Description
    The endometrioma is removed according to standard surgery.
    Arm Title
    Laser technique
    Arm Type
    Experimental
    Arm Description
    The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser
    Intervention Type
    Procedure
    Intervention Name(s)
    CO2 (carbon dioxide) laser vaporisation
    Intervention Description
    CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma
    Intervention Type
    Procedure
    Intervention Name(s)
    Stripping technique
    Intervention Description
    Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue
    Primary Outcome Measure Information:
    Title
    Ovarian reserve
    Description
    Antral follicular count by ultrasound: number of antral follicles.
    Time Frame
    7 months
    Title
    Ovarian volume
    Description
    Ovarian volume will be assesses by ultrasound, units given with milliliters
    Time Frame
    7 months
    Secondary Outcome Measure Information:
    Title
    Pregnancy rate
    Description
    Pregnancy rate will be recorded during the 6 months follow-up
    Time Frame
    6 months after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18 and 45. Bilateral endometriomas. Endometrioma size > 3 cm. Pain and/or infertility as indication to surgical treatment. Exclusion Criteria: History of cancer. Suspected malignancy. Evidence of premature ovarian failure.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco Carmona, MD PhD
    Organizational Affiliation
    Hospital Clinic of Barcelona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy

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