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Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic ovarian endometriotic cyst
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Infertile woman aged 18-35 years old.
  • Endometriotic ovarian cyst with size less than or equal 5 cm.

Exclusion Criteria:

  • Other than included criteria.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group A; laparoscopic ovarian endometrial aspiration

    group B; laparoscopic ovarian endometrial stripping

    Group c laparoscopic ovarian endometrial de-roofing

    Arm Description

    Laparoscopic ovarian endometrial aspiration will be done for thirty patients with ovarian endometriotic cyst. .

    Laparoscopic ovarian endometrial stripping will be done for thirty patients with ovarian endometriotic cyst.

    Laparoscopic ovarian endometrial de-roofing and bed cauterization will be done for thirty patients with ovarian endometriotic cyst.

    Outcomes

    Primary Outcome Measures

    The antral follicular count which records the number of visible ovarian follicle (2-10 mm mean diameter) seen by transvaginal ultrasound on menstrual cycle( days 2_5)
    Cut point(3-10)

    Secondary Outcome Measures

    Anti mullerian hormone level in blood secreted by antral follicles 2-6 mm diameter in ovary
    Measure in ng/ml cut point is( 0.2-0.7)
    Follicle stimulating hormone in blood secreted by antral follicles on day 2-4 of menstrual cycle
    Cut point is(10-20) measured in international unit/litre

    Full Information

    First Posted
    March 16, 2016
    Last Updated
    April 26, 2016
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02754648
    Brief Title
    Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
    Official Title
    Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with ovarian endometrioma or not?
    Detailed Description
    Primary objective: To assess antral follicular count before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization. Secondary objectives To assess anti mullerian hormone level, follicle stimulating hormone level ,Doppler blood flow before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A; laparoscopic ovarian endometrial aspiration
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic ovarian endometrial aspiration will be done for thirty patients with ovarian endometriotic cyst. .
    Arm Title
    group B; laparoscopic ovarian endometrial stripping
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic ovarian endometrial stripping will be done for thirty patients with ovarian endometriotic cyst.
    Arm Title
    Group c laparoscopic ovarian endometrial de-roofing
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic ovarian endometrial de-roofing and bed cauterization will be done for thirty patients with ovarian endometriotic cyst.
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic ovarian endometriotic cyst
    Primary Outcome Measure Information:
    Title
    The antral follicular count which records the number of visible ovarian follicle (2-10 mm mean diameter) seen by transvaginal ultrasound on menstrual cycle( days 2_5)
    Description
    Cut point(3-10)
    Time Frame
    One month
    Secondary Outcome Measure Information:
    Title
    Anti mullerian hormone level in blood secreted by antral follicles 2-6 mm diameter in ovary
    Description
    Measure in ng/ml cut point is( 0.2-0.7)
    Time Frame
    One month
    Title
    Follicle stimulating hormone in blood secreted by antral follicles on day 2-4 of menstrual cycle
    Description
    Cut point is(10-20) measured in international unit/litre
    Time Frame
    One month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infertile woman aged 18-35 years old. Endometriotic ovarian cyst with size less than or equal 5 cm. Exclusion Criteria: Other than included criteria.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve

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