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Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency (OLIVA)

Primary Purpose

Primary Ovarian Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OLIVA device
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Ovarian Insufficiency focused on measuring Primary ovarian insufficiency, In-vivo activation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Peri/menopausal women undergoing laparoscopic oophorectomy

Exclusion Criteria:

  • Women with ovarian malignancy
  • Women with polycystic ovarian syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    ex vivo activation

    in vivo activation

    POI OLIVA

    Arm Description

    'OLIVA device' in patients that undergo oophorectomy on the cortex of the removed ovary we will perform 5 parallel slashes 3 cm long. this will be followed by investigation by the pathologist as to the depth of cuts.

    'OLIVA device' in patients undergoing oophorectomy before the resection from is pedicle on cortex of the ovary we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels.

    'OLIVA device' in patients with premature ovarian failure and following safety data from arm 2 activation by ovarian slashing will be performed laparoscopically by closed cutting device (OLIVA). follow-up by sonography and hormonal markers of ovarian activity

    Outcomes

    Primary Outcome Measures

    Depth of cuts and closeness to blood vessel
    The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device

    Secondary Outcome Measures

    Proximity of cuts to blood vessel
    The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device

    Full Information

    First Posted
    January 13, 2017
    Last Updated
    January 26, 2017
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03034616
    Brief Title
    Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency
    Acronym
    OLIVA
    Official Title
    in Vivo Activation of Ovarian Cortex in Premature Ovarian Insufficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The OLIVA device will enable to perform shallow slashes on the ovarian cortex in patients undergoing oophorectomy. Prior to the resection of the ovary from the pedicle we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels and later.
    Detailed Description
    The OLIVA device is built of 5 parallel razor blades enclosed by protective cap

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Ovarian Insufficiency
    Keywords
    Primary ovarian insufficiency, In-vivo activation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    ex vivo activation
    Arm Type
    Experimental
    Arm Description
    'OLIVA device' in patients that undergo oophorectomy on the cortex of the removed ovary we will perform 5 parallel slashes 3 cm long. this will be followed by investigation by the pathologist as to the depth of cuts.
    Arm Title
    in vivo activation
    Arm Type
    Active Comparator
    Arm Description
    'OLIVA device' in patients undergoing oophorectomy before the resection from is pedicle on cortex of the ovary we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels.
    Arm Title
    POI OLIVA
    Arm Type
    Active Comparator
    Arm Description
    'OLIVA device' in patients with premature ovarian failure and following safety data from arm 2 activation by ovarian slashing will be performed laparoscopically by closed cutting device (OLIVA). follow-up by sonography and hormonal markers of ovarian activity
    Intervention Type
    Device
    Intervention Name(s)
    OLIVA device
    Intervention Description
    OLIVA device is a laparoscopic device with a standard handle and a tip built of 5 parallel razor blades enclosed by protective cap opened by a separate button. This device will enable to perform shallow slashes on the ovarian cortex following the grasping of the ovary without damaging other abdominal and pelvic organs
    Primary Outcome Measure Information:
    Title
    Depth of cuts and closeness to blood vessel
    Description
    The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device
    Time Frame
    Up to 30 days after procedure
    Secondary Outcome Measure Information:
    Title
    Proximity of cuts to blood vessel
    Description
    The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device
    Time Frame
    Up to 30 days after procedure

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Peri/menopausal women undergoing laparoscopic oophorectomy Exclusion Criteria: Women with ovarian malignancy Women with polycystic ovarian syndrome

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency

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