Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency

Study Overview
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Brief Summary
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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
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The OLIVA device is built of 5 parallel razor blades enclosed by protective cap

Official Title
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in Vivo Activation of Ovarian Cortex in Premature Ovarian Insufficiency

Conditions
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Primary Ovarian Insufficiency

Intervention / Treatment
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* Device: OLIVA device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peri/menopausal women undergoing laparoscopic oophorectomy Exclusion Criteria: Women with ovarian malignancy Women with polycystic ovarian syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ex vivo activation<br>'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<br>* 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<br>|
| Active Comparator: in vivo activation<br>'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<br>* 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<br>|
| Active Comparator: POI OLIVA<br>'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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 30 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary ovarian insufficiency, In-vivo activation