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

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ClinicalTrials.gov Identifier: NCT03034616
Recruitment Status : Unknown
Verified January 2017 by Ariel Revel, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ariel Revel, Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Device: OLIVA device Not Applicable

Detailed Description:
The OLIVA device is built of 5 parallel razor blades enclosed by protective cap

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: in Vivo Activation of Ovarian Cortex in Premature Ovarian Insufficiency
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: ex vivo activation

'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.

Device: OLIVA device

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


Active Comparator: in vivo activation
'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.
Device: OLIVA device

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


Active Comparator: POI OLIVA
'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
Device: OLIVA device

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 Measures :
  1. Depth of cuts and closeness to blood vessel [ Time Frame: Up to 30 days after procedure ]
    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 :
  1. Proximity of cuts to blood vessel [ Time Frame: Up to 30 days after procedure ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Peri/menopausal women undergoing laparoscopic oophorectomy

Exclusion Criteria:

  • Women with ovarian malignancy
  • Women with polycystic ovarian syndrome

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Responsible Party: Ariel Revel, Principal investigator, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03034616     History of Changes
Other Study ID Numbers: 029416
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ariel Revel, Hadassah Medical Organization:
Primary ovarian insufficiency
In-vivo activation

Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn