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

in Vivo Activation of Ovarian Cortex in Premature Ovarian Insufficiency

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.

Study Overview

• Status: Unknown
• Conditions: Primary Ovarian Insufficiency
• Intervention / Treatment: Device: OLIVA device

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Peri/menopausal women undergoing laparoscopic oophorectomy

Exclusion Criteria:

• Women with ovarian malignancy
• Women with polycystic ovarian syndrome

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Primary ovarian insufficiency; In-vivo activation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: 029416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO